EMC Documentum ElectronicTrial MasterFile Documentum®ElectronicTrial MasterFile Version4.0 UserGuide EMCCorporation CorporateHeadquarters Hopkinton,MA01748-9103 1-508-435-1000

EMC® Documentum® Electronic TrialMaster File

Version 4.0

User Guide

EMC CorporationCorporate Headquarters

Hopkinton, MA 01748-91031-508-435-1000www.EMC.com

Legal Notice

Copyright © 2012-2016 EMC Corporation. All Rights Reserved.

EMC believes the information in this publication is accurate as of its publication date. The information is subject to changewithout notice.

THE INFORMATION IN THIS PUBLICATION IS PROVIDED “AS IS.” EMC CORPORATIONMAKES NO REPRESENTATIONSOR WARRANTIES OF ANY KINDWITH RESPECT TO THE INFORMATION IN THIS PUBLICATION, AND SPECIFICALLYDISCLAIMS IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Use, copying, and distribution of any EMC software described in this publication requires an applicable software license.

For the most up-to-date listing of EMC product names, see EMC Corporation Trademarks on EMC.com. Adobe and Adobe PDFLibrary are trademarks or registered trademarks of Adobe Systems Inc. in the U.S. and other countries. All other trademarksused herein are the property of their respective owners.

Documentation Feedback

Your opinion matters. We want to hear from you regarding our product documentation. If you have feedbackabout how we can make our documentation better or easier to use, please send us your feedback directly [email protected]

Table of Contents

Preface ................................................................................................................................. 7

Chapter 1 Overview ...................................................................................................... 9TMF Structure .................................................................................................. 10File Plans ......................................................................................................... 13Registration Forms ........................................................................................... 15Trial Activation using File Plan Templates .......................................................... 16File Plan Template Updates while Trials are Active ............................................. 18Progress Tracking ............................................................................................. 18Trial Schedule Adjustments ............................................................................... 20Trial Registration Form Lifecycle Model ............................................................. 21Trial Suspension and Locking ............................................................................ 22Clinical Crossover Documents........................................................................... 23

Chapter 2 Roles ........................................................................................................... 25Trial Managers and Product Managers ............................................................... 25Contributors and Investigators .......................................................................... 26Authors and Document Coordinators ................................................................ 28Reviewers and Approvers ................................................................................. 29Inspectors and Auditors.................................................................................... 29Readers............................................................................................................ 30Administrators ................................................................................................. 30

Chapter 3 Set Up and Administer Trials ....................................................................... 31Defining Information in Registration Forms ....................................................... 31Creating a Product Registration Form ............................................................ 32Creating a Clinical Trial Registration Form ..................................................... 34Creating a Clinical Trial Registration Form for Crossover Documents .............. 35Creating a Country Registration Form ........................................................... 36Creating a Site Registration Form .................................................................. 37Registration Form Lifecycle Models ............................................................... 38Product Registration Form Lifecycle .......................................................... 38Clinical Trial Registration Form Lifecycle ................................................... 40Clinical Trial Country Registration Form Lifecycle ...................................... 41Clinical Trial Site Registration Form Lifecycle ............................................. 42

Restricting Access to Registration Forms ........................................................ 43Assign Users and Groups to their Roles ......................................................... 43

External Trial Participant Registrations .............................................................. 44Security Considerations for Internal and External Users .................................. 45Giving Access to External Trial Participants.................................................... 46Verifying External Trial Participant Access ..................................................... 47

3

Table of Contents

Creating a File Plan........................................................................................... 48Creating a File Plan Template ........................................................................ 49File Plan Template Activation ........................................................................ 51Activating the File Plan Template .................................................................. 51Creating Registration Forms for the Trial........................................................ 51Associating a File Plan Template with a Product Registration Form ................. 52Associating a File Plan Template with a Trial Registration Form ...................... 52Associating a File Plan Template with a Country Registration Form................. 53Associating a File Plan Template with a Site Registration Form........................ 54Building the File Plan for the Trial.................................................................. 54File Plan Validation....................................................................................... 54Validating the File Plan ................................................................................. 55Adjusting the Trial Schedule.......................................................................... 55Activating the File Plan for a Clinical Trial ..................................................... 55Activating the Trial ....................................................................................... 56eTMF Folder Structure .................................................................................. 56Product-level TMF Placeholders and Documents ............................................ 57

Updating the eTMF Structure with Changes....................................................... 58Viewing Clinical Trial Progress.......................................................................... 58Locking a Clinical Trial ..................................................................................... 58Registration Form Changes that apply to Existing Documents ............................. 59Changing a Product Code for a Product ......................................................... 59Changing Product-related Information for a Product ...................................... 60Changing Clinical Trial Information............................................................... 60Moving Trial Documents to a Different Product.............................................. 61Changing the Location of a Site ..................................................................... 61Changing the Name of a Site ......................................................................... 62Associating Multiple Products with a Clinical Trial ......................................... 63

Chapter 4 Import and Index Trial Documents .............................................................. 65Import and Indexing Process ............................................................................. 65Placeholders..................................................................................................... 67Finding a Placeholder ....................................................................................... 67Finding a Placeholder using a Public Search ....................................................... 67Viewing Placeholder Properties ......................................................................... 68Finding a Registration Form .............................................................................. 68Import Documents............................................................................................ 69Importing from the Welcome Page................................................................. 69Importing to a Placeholder ............................................................................ 69Importing to a Registration Form................................................................... 69

Indexing a Document in the Finalize Indexing List.............................................. 70Indexing a Document in the Doc List ................................................................. 70Finding a Document ......................................................................................... 71

Chapter 5 Uploading Site-Based Documents for Investigation .................................... 73Accessing the Investigator Workspace................................................................ 73Viewing the Site Registration Forms .................................................................. 73Viewing the Missing and Key Documents for a Site ............................................ 74Importing Documents to a Placeholder .............................................................. 74

Chapter 6 Create Trial Documents ............................................................................... 75Controlled Documents ...................................................................................... 75

4

Table of Contents

Creating a Document .................................................................................... 76Creating a Clinical Crossover Document ........................................................ 77Associating a Crossover Document with a Regulatory Application .................. 78Creating a Reference Document..................................................................... 78

File Naming and Versioning .............................................................................. 78Omitting a Placeholder ..................................................................................... 79Reinstating a Placeholder .................................................................................. 80Document Updates ........................................................................................... 80Editing a Document ...................................................................................... 80Checking in a Document ............................................................................... 80Sharing a Document across Sites.................................................................... 81

Configuring Content Templates ......................................................................... 81Creating a Content Template ......................................................................... 82Modifying a Content Template ...................................................................... 82

Importing and Exporting Multiple Documents ................................................... 83Creating a TMF Bulk Import-Export Package for a Trial .................................. 84Refreshing the Value Assistance for the Bulk Import-ExportSpreadsheet ................................................................................................. 85Zip and Export the TMF Bulk Import-Export Package ..................................... 85Populating the Bulk Import-Export Spreadsheet ............................................. 88Importing the Document Package ZIP File ..................................................... 89Starting the Bulk Import of Documents .......................................................... 89

Chapter 7 Review and Approve Trial Documents ......................................................... 91Workflow Process ............................................................................................. 91Document Review and Approval....................................................................... 94Launching the Collaborative Editing Workflow .............................................. 94Launching the Review Workflow................................................................... 95Self-approving a Document........................................................................... 95

Performing Tasks in a Workflow ........................................................................ 95Viewing the Audit Trail................................................................................. 97Categorizing Inbox Tasks .............................................................................. 97

Processing Documents in a Workflow ................................................................ 98Collaborative Editing .................................................................................... 98Editing a Document in a Workflow ................................................................ 98Consolidating Document Changes................................................................. 99Reviewing Documents in a Review Task ...................................................... 100Reviewing Document Feedback from Reviewers .......................................... 101Approving Documents ............................................................................... 102Reviewing Document Feedback from Approvers .......................................... 102

Working with Final Documents ....................................................................... 103Suspending a Document ............................................................................. 103Withdrawing a Document ........................................................................... 104Deleting Documents Permanently................................................................ 104Superseded Documents .............................................................................. 105Expiry Review of Documents ...................................................................... 105Updating the Expiry Review Date for a Document........................................ 106

Viewing Document Status ............................................................................... 106Viewing Workflow Progress ............................................................................ 107Workflow Task Performer Changes .................................................................. 108Updating Workflow Task Performers ........................................................... 108Stopping a Workflow .................................................................................. 109Delegating a Task as a Workflow Supervisor ................................................ 109Delegating a Task as a User ......................................................................... 110

5

Table of Contents

Reassigning Roles....................................................................................... 110

Chapter 8 Inspect a Trial ............................................................................................ 111Locating Documents ....................................................................................... 111Finding Documents .................................................................................... 111

Finding Documents using Facets ..................................................................... 112Viewing Documents and their Properties ......................................................... 112Viewing Documents Side-by-side .................................................................... 112Adding Notes................................................................................................. 113Viewing and Deleting Notes............................................................................ 113Viewing the Document History ....................................................................... 113Deleting and Restoring a Document................................................................. 113Export the Doc List to Microsoft Excel.............................................................. 114Additional Menu Functions............................................................................. 114Additional Menu Functions for Trial Registration Forms ............................... 114Additional Menu Functions for TMF Placeholders ........................................ 116Additional Menu Functions for TMF Documents .......................................... 117

Chapter 9 Find Documents ........................................................................................ 119

6

Preface

This guide describes the default behavior of EMC Documentum Electronic Trial Master File(Documentum eTMF), part of the EMC Documentum for Life Sciences solution suite. This solution isbuilt on the Documentum D2 web application and Documentum platform.

Documentum D2 is a web-based application that enables users to store, retrieve, and managedocuments in a Documentum repository. It is highly customizable through a configurationapplication that does not require programming knowledge. Documentum D2 consists of thefollowing components:

• Documentum D2 Configuration (D2-Config): The configuration application that enables you toconfigure settings for security, workflows, document classification, and the client user interface.

• Documentum D2 Client (D2 Client): The main application that is used to interact withdocuments in the repository.

Additional Documentum D2 components that are used in Documentum eTMF are:• Documentum D2 Office Integration (O2): Microsoft Office and Outlook propertiessynchronization for documents and email.

• Documentum D2 PDF Integration (C2): PDF file control for watermarking and controlledprinting.

Intended AudienceThis guide is intended for those who use the EMC Documentum Electronic Trial Master File solution,part of the EMC Documentum for Life Sciences solution suite.

Revision History

Revision Date Description

June 2016 Added a note about annotations not supportedin Microsoft Excel or Microsoft PowerPointnative formats in Editing a Document in aWorkflow, page 98.

Added a note in the section, .

7

Preface

Revision Date Description

Added a note about the Track Changes featurein Microsoft Word 2013 in Editing a Documentin a Workflow, page 98.

June 2015 Initial publication.

8

Chapter 1Overview

The Trial Master File (TMF) is a centralized global repository of documents related to a clinical studyor trial. Researchers use the terms clinical study and clinical trial interchangeably. Throughoutthe lifetime of a drug product or treatment, investigators can initiate any number of trials in orderto prove the safety and efficacy of the therapy. These studies generate significant amounts ofdocumentation, which must be stored in the TMF for compliance purposes.

Some of these documents are submissible and must be included in regulatory submissions to a healthauthority in order to gain approval for sale of the drug product. Other documents in the TMF providesupporting evidence, but they are not part of the regulatory submissions. The health authorityusually mandates that organizations retain the entire TMF throughout the lifetime of the product.The health authority can inspect and audit the TMF documents at any time.

The EMC Documentum Electronic Trial Master File (Documentum eTMF) solution, part of the EMCDocumentum for Life Sciences solution suite, enables Life Sciences organizations to address thechallenge of capturing, collating, storing, securing, and retaining massive amounts of documentsfrom clinical studies conducted at numerous sites and countries around the world. DocumentumeTMF, built on Documentum, is used in enterprise-scale information management applications inLife Sciences and supports TMF management in conformance with the latest industry standards.

With this solution, you can:

• Plan your TMF for clinical trials based on predefined file plan templates

• Provide placeholders for clinical document authors, study monitors, and other participants tofind, upload, and create content

• Bulk-upload existing or externally-produced documents, such as documents delivered by externalContract Research Organizations (CROs)

• Obtain document metadata automatically to facilitate search and discovery and to reduce theneed for manual data entry

• Use predefined review and approval workflows, electronic sign-off, and secure auditing to enable21 CFR-11 compliance

• Monitor the progress of clinical trials globally

• Extend trials to new countries and new sites

• Delegate planning to national country and local site managers while maintaining centralizedcontrol to ensure compliance

• Facilitate Inspection-Readiness through collection, completion, and missing document reportingon Products, Trials, and Sites

9

Overview

• Manage access to trials based on user roles

• Lock down trial-related documents when the trial is complete

• Integrate the solution with your Clinical Trial Management System (CTMS) in order tosynchronize CTMS-controlled information with your Documentum eTMF system

This section contains the following topics:

• TMF Structure, page 10

• File Plans, page 13

• Registration Forms, page 15

• Trial Activation using File Plan Templates, page 16

• File Plan Template Updates while Trials are Active, page 18

• Progress Tracking, page 18

• Trial Schedule Adjustments, page 20

• Trial Registration Form Lifecycle Model, page 21

• Trial Suspension and Locking, page 22

• Clinical Crossover Documents, page 23

TMF StructureThe organization of the TMF is fully configurable, but the standard installation has filing areas, zones,and sections. Each section contains one or more artifacts (document types). The standard installationsupports all of the zones, sections, and artifacts defined in the DIA TMF 2.0 reference model.

The TMF supports the following filing areas:

• Central Trial Documents: Contains global trial-level documents applicable to all countries and allsites for a particular trial, except when you specify otherwise.

• Country-specific: Contains national documents. These artifacts are applicable to all sites withina particular country. A trial can have several country-specific filing areas. The system canautomatically create a separate filing area for each country conducting a trial.

• Site-specific: Contains site-specific artifacts that are applicable to an individual site. The systemcan automatically create a separate filing area for each site conducting a trial.

Above the trial level, there is an additional General Documents filing area that enables the filing ofproduct-level (or compound-level) documents. These documents pertain to all trials conducted forthe product and are therefore shared across the trials.

10

Overview

The following figure illustrates the folder structure in the standard installation grouped by productcode and trial phase within the Clinical cabinet:

You can change the general filing structure and naming conventions by modifying the DocumentumD2 auto-filing and auto-naming rules using Documentum D2 Configuration, known as D2-Config.For example, in a small-to-medium size organization, you can remove the top-level (product group)folders to make it easier to navigate the structure. Similarly, if you do not want to group the TMFfolders by study phase, you can remove the clinical study phase folder level so that the TMF foldersfor each study appear directly underneath the product folder.

11

Overview

The following figure shows the filing areas for each trial:

Each filing area is divided into zones and sections containing the artifacts (TMF documents), whichby default are named and numbered in accordance with the DIA TMF reference model. This ispredefined in a Documentum D2 taxonomy (the TMF Classification by Artifact taxonomy). End usersdo not have to think about TMF document naming and numbering conventions or where they shouldput documents in the structure. They select the appropriate artifact name (document type) and thesystem auto-files, numbers, and names the document in accordance with the preconfigured taxonomy.

12

Overview

The following figure shows the predefined TMF Classification by Artifact taxonomy in DocumentumD2 (viewed as a Microsoft Excel spreadsheet):

You can modify and extend the taxonomy using D2-Config. The standard installation contains apredefined DIA TMF 2.0 reference model. You can extend the taxonomy to include customer-specificartifacts or to support additional reference models. Documentum eTMF supports multiple referencemodels, so you can implement the latest standard reference models as they emerge or providedifferent reference models for different parts of the business using their own terminology.

File PlansThe system generates the folder structure automatically according to a predefined file plan. A fileplan is a Microsoft Excel spreadsheet specifying the expected artifacts in each filing area. The fileplan specifies whether artifacts are required (must-have), recommended (should-have), or optional(could-have) documents. Before activating the trial, Trial Managers usually set up the file plan basedon predefined templates. The file plan also specifies the cardinality rules for each artifact. Cardinalityrules define whether each artifact is repeatable (more than one document can be provided) andthe minimum number of expected documents in each case. The system uses this information todetermine the level of completion of each artifact.

13

Overview

The following figure shows an example Microsoft Excel spreadsheet file plan:

In the Scope column of the file plan, you can specify:

• Product: Defines a product-level artifact filed in the General Documents filing area.

• Trial: Defines a Central Trial Documents artifact.

• All Countries: Defines a country-level artifact for each country conducting a trial.

• Specific Country: Defines an individual country-level artifact for a particular country.

• All Sites: Defines a site-level artifact for each site conducting a trial, which you can restrict toa particular country.

• Specific Site: Defines an individual site-level artifact for a particular site.

You can also redefine the same artifact at different levels in separate rows of the spreadsheet. Forexample, you can define an artifact that is required at the trial level and optional at the site level.

Creating a File Plan, page 48 provides more information on configuring and using file planspreadsheets.

When you activate a trial, the system processes the file plan spreadsheet. This processing includescreating placeholder documents (or just placeholders) for each expected artifact, filing thoseplaceholders into the configured folder structure, assigning security to the folders and placeholders,and enabling the collection of documents for that trial. This folder structure helps documentcontributors to identify the documents they should provide and upload the relevant content fileinto each placeholder.

As end users upload content for the placeholders, the system automatically removes the placeholdersas appropriate. Repeatable artifacts enable users to provide multiple documents for the same artifact.Each document is automatically given a unique item number (or sequence number) in that case,which is appended to the standard artifact number. The system retains the placeholder to enable

14

Overview

the uploading of additional documents until the expected number is reached, at which time theplaceholder is removed. If a repeatable placeholder has an expected count of "0" (infinite), the systemnever automatically removes the placeholder.

Placeholders enable the system to track the progress of the TMF and to identify missing documentsin the reports. The placeholders can be empty (no-content) documents or they can provide initialcontent, such as a blank form for the users to fill in. In the standard installation, the placeholders aregenerated as contentless objects. To provide initial content, you can configure content templates foreach artifact, or for a set of artifacts, and enable them for use with the relevant placeholders. Theplaceholders also provide most of the required document attributes automatically, so users only needto enter document-specific metadata.

Configuring Content Templates, page 81 provides more information.

End users do not need to create and manage, or even be aware of, the folder structure. The systemgenerates it automatically based on the predefined file plan. If the file plan changes or the trialextends to new countries and sites, the system recognizes that new placeholders are required for thenew artifacts and creates the corresponding folders for the new countries and sites automatically.If end users delete documents, the system automatically regenerates placeholders for the missingdocuments.

The TMF reconciliation process completes these tasks. It compares the current state of the TMF withits file plan, generates any missing placeholders, removes placeholders that are no longer required,and updates the progress statistics on the registration form for the trial. The validity and progressof each entry in the file plan automatically synchronizes the status with the master file plan. Theycan use this information to identify and correct file plan configuration errors. They can also use thefeedback for detailed progress monitoring of active trials.

Registration FormsDocumentum eTMF uses Registration Forms to model the entities and their metadata which makeup a clinical trial. Documents and placeholders inherit registration form metadata when they areassociated to one of these entities.

There are four types of registration forms related to TMFs:

• Product Registration Form: Registers product codes and product-specific information, such aschemical names, trade names, and generic names.

• Clinical Trial Registration Form (Trial Registration Form): Registers individual trials. Each trialis associated with a product registration and must have a unique trial ID. Clinical CrossoverDocuments, page 23 provides more information about clinical trial registration form for crossoverdocuments between Documentum R&D and Documentum eTMF.

• Country Registration Form: Registers the countries where the sites participating in a trial arelocated. A trial can have multiple Country Registration Forms, but each Country RegistrationForm is associated to one trial.

• Site Registration Form: Registers the individual sites that participate in the trial. Just as forCountry Registration Forms, a trial can have multiple Site Registration Forms, but each SiteRegistration Form pertains to one trial and must relate to a pre-registered country (a CountryRegistration Form) for that trial. This means that if the same site participates in three differenttrials, there will be three registration forms for that site - one for each trial.

15

Overview

The relationships between the various registration forms define a hierarchy that reflects the structureof the TMF as shown in the following figure:

In the preceding example, product X registers with three trials (CTX0001, CTX0002, and CTX0003).The first trial is in one site only, in the US. The second is in two separate sites within the US. The thirdis in two separate sites in different countries – one in Sweden (SV) and one in Germany (DE).

You can create these registration forms manually and maintain them directly in Documentumusing the D2 Client application. You can also create all types of registration forms automaticallythrough the TMF Software Development Kit (SDK), a Web Services API that enables Documentum tosynchronize with Clinical Trial Management Systems (CTMS). The SDK allows CTMS to create andupdate registration forms in the Documentum eTMF system. And changes to those registration formsare automatically represented in your trial. For example, if a new site is recruited for an ongoing trial,that information is entered into your CTMS system. The CTMS issues a call to the TMF SDK, creatingthe site registration form. The TMF reconciliation method runs and creates the placeholders andfolders for the new site. The reports automatically update (because the placeholders and registrationforms exist), and collection of the expected documents can begin.

Using the TMF SDK to integrate with your CTMS system requires development effort. For additionalassistance, contact EMC IIG Professional Services.

Trial Activation using File Plan TemplatesActivating a Trial Registration Form causes the system to generate the initial TMF structure, based onits file plan, and to monitor the progress of the TMF in relation to the file plan. You always activateTMFs at the Trial Registration Form level and not at the Product, Country, or Site level. Activating aProduct, Country, or Site Registration Form makes that registration form available for use. It does notcause the system to generate any TMF placeholders.

16

Overview

At a minimum, you must create a Product Registration Form and a Trial Registration Form foreach trial. You must create a file plan at the Trial Registration Form level before activating the trial.Country and Site Registration Forms are optional and can be added incrementally. However, if youknow the initial countries and sites conducting the trial in advance, it is better to establish countryand site registrations for them before activating the trial. This enables you to add country-specificand artifact-specific artifacts to the file plan. In the absence of country and site registrations, you canonly add All Countries and All Sites entries to the file plan. These artifacts then apply to all countriesand sites that are later registered, which may not be your intent.

The file plan is stored as the main content of the Trial Registration Form in Documentum, in MicrosoftExcel format. While you can build the file plan from scratch, users typically compile it from a set ofpredefined file plan templates associated with the various registration forms. A file plan template is apredefined file plan spreadsheet defining a subset of the artifacts that are normally associated with aparticular product, trial, country, or site. Although you always activate trials at the trial level, it ispossible to associate file plan templates with registration forms at any level.

If you use predefined file plan templates at various levels, you can build a default file plan for a trialautomatically before activating it. To create a default file plan, you use the Load File Plan contextmenu option, which is available after you select a Trial Registration Form. This option compiles afile plan in top-down order from any file plan templates associated with registration forms for thetrial at the product, trial, country, and site levels. You must have at least one product-level file plantemplate or trial-level file plan template to create a file plan. File plan templates at the countryand site levels are optional.

The default file plan at the trial level can inherit parts of the file plan templates from other levels.The following figure provides an example of how the system compiles the default file plan for a trialfrom a hierarchy of file plan templates:

17

Overview

It is not necessary to define file plan templates at all levels. In practice, Trial Managers are most likelyto create file plan templates only at the product level and in some cases at the trial level. You can useproduct-level file plans to provide a list of standard artifacts that usually apply to all trials relatedto a particular product, or set of related products, and make these default rules (overridable) ormandatory rules (non-overridable) to enforce compliance with business policies. It is also possible todelegate file planning to the regions using country-level and site-level file plans, if necessary.

File Plan Template Updates while Trials areActiveIf you update a file plan template, for example, with the addition of planned artifacts, the new artifactscan transfer automatically into the file plans for the active trials that refer to those templates. Thesefile plan updates result from the cumulative update feature of the trial reconciliation process. It isoptional and enabled by default, but you can disable it using D2-Config, if necessary. When enabled,the reconciliation process checks the relevant file plan templates at each level on each cycle (thosethat make up the default file plan) and ensures that none of the artifacts listed on those templates aremissing from the current file plan. If they are missing, the system adds the missing artifacts to the fileplan before validating and reconciling it. In this way, the system includes all new file plan templateentries in the file plans for the active trials that refer to them. However, existing entries in the file plando not change. If Trial Managers change the default file plan, their changes are preserved.

Likewise, if Trial Managers delete rows from the file plan, the system can add the deleted rowsback to the file plan automatically on the next reconciliation cycle if they are present in a file plantemplate. You can prevent this by changing the inclusion rule setting to Not Required for the relevantartifacts, instead of deleting them completely. The reconciliation process ignores these entries andautomatically deletes any placeholders that exist for them.

You should mark artifacts as Not Required in the file plan instead of deleting them. This preservesa record of the artifacts that were originally in the file plan in case you decide to reinstate them inthe future.

Progress TrackingThe trial reconciliation process creates missing placeholders and removes placeholders that are nolonger required. The trial reconciliation process also finds completed documents in the TMF andcompares the number of completed documents for each artifact with the expected document count inthe corresponding row of the file plan. The process uses this information to determine how manydocuments are missing or how many additional completed documents over and above the expectednumber exist, if any. Additional completed documents count as extra documents but do not influencethe overall level of progress. For example, if 4 documents are expected for a particular artifact and 3complete documents are provided, the artifact is 75% complete. If 4 documents are provided, it is100% complete. If 5 documents are provided, it is still 100% complete, with 1 extra document.

A document is complete if it is both Current (the latest version) and Final (in the Final lifecycle state).Work-in-progress documents (index and draft documents), non-current versions, and withdrawndocuments are not complete. After you upload documents into the system, end users must review,approve, and mark them as Final before the system counts them as complete.

18

Overview

The system records progress information automatically in three places:

• In the Trial Registration Form properties, you can view progress summary statistics using theProgress Summary menu option of the registration form.

• In the tmf_progress_history registered table in Documentum, information can be used to createtrend reports (progress history over time).

• In the file plan spreadsheet, the Status column for each row contains progress information, ifavailable. In this way, the file plan spreadsheet acts as a detailed progress report.

The following figure shows a progress statistics example for a trial:

The following example shows progress details for each artifact recorded in the file plan (viewed inMicrosoft Excel):

19

Overview

Trial Schedule AdjustmentsIn the Trial Registration Form properties, or through the Adjust Schedule menu option, you can timeconstrain the trial by entering planned start and end dates for each stage in the file plan.

The following figure shows an example of defining a trial schedule:

With this trial scheduling information, the system can report on overall progress and can indicatewhether the trial is on track (condition Green), close to limits (Amber), or behind schedule (Red),depending on the current progress compared to the expected progress over time. The system allowsfor a certain amount of slack time at the start of the trial, during which no progress is expected toallow for setup and initial document preparation. It projects the expected level of progress for thecurrently active stage depending on the elapsed time since the planned start date. If progress is abovethis limit, the system sets the condition code to Green. If progress is just below the limit, it sets thecondition code to Amber. If progress is well below the limit, it sets the condition code to Red. TrialManagers can use this information to assess the general risk of overrun for the trial. This is just anindication of the risk of overrun and may not necessarily be cause for concern, given that documentsare often completed and uploaded in batches.

You do not have to plan a trial in stages. For example, you can put all of the artifacts in a file plan instage 1. However, planning a trial in stages enables each stage to activate sequentially or in paralleland you can track the overall progress of each stage. For example, you can put all of the initialtrial set-up artifacts in stage 1, the main artifacts in stage 2, and the finalization (trial closeout and

20

Overview

summary reporting) artifacts in stage 3. Then you can activate stage 2 (roll over the trial to the nextstage) when the stage 1 artifacts are completed.

Trial Registration Form Lifecycle ModelTrial Registration Forms have a predefined lifecycle configuration to enable Clinical Trial Managers tomanage the TMF in an orderly way.

The following figure illustrates the lifecycle state transitions:

In this figure, the solid lines represent lifecycle menu actions that Trial Managers who are assignedto the form can perform. The Unlock function is a special case. It is further restricted to membersof the Controlled Document Administrators group (cd_admingroup). In order to unlock a lockedtrial, users must be members of this group in addition to being a Trial Manager. The dotted lines

21

Overview

represent lifecycle transitions carried out automatically by the system on completion of the process.The Initializing, Refreshing, Locking, and Unlocking states are transitory states, indicating that thesystem is processing the TMF in the background.

The display does not refresh automatically when background processing completes, so the statusof the registration form may have changed without indication. Users can force a display refresh byclicking the current folder icon in the folder tree browser.

The preceding figure does not show some functions that do not cause the status of the TrialRegistration Form to change: Load File Plan, Validate, Adjust Schedule, Progress Summary, and thestandard functions including Edit, Check out, and Check in. The Load File Plan function appears asReload File Plan in the context menu while the trial is active to emphasize the fact that it can replacethe existing file plan (subject to user confirmation). You should preserve a copy of the current fileplan by creating a new version of the Trial Registration Form before using this function.

Documentum eTMF provides a Documentum D2 Batch Lifecycle configuration to enable you toactivate, refresh, and roll over Trial Registration Forms automatically on a schedule, as required. Forexample, you can refresh the TMFs automatically using an overnight job. It is very important that youschedule the Documentum D2 Batch Lifecycle job to run during quiet periods, if possible, in order tominimize the impact of this additional background processing on the end users.

Trial Suspension and LockingYou may need to suspend document preparation activity temporarily for a particular study duringan investigation or audit. A Trial Manager can suspend a trial by changing the Trial RegistrationForm status from Active to Suspended using the Suspend menu option. While the Trial RegistrationForm is in the Suspended state, the system prevents additional documents related to that trial fromchanging to the Final state. Auditors and investigators scrutinize the current set of Final documents,but they do not usually have access to other documents, such as work-in-progress versions.

End users can continue to upload work-in-progress documents and send them for review andapproval. If they try to make new documents Final (including new versions of existing documents),they receive a message indicating that they cannot make the document Final because the associatedtrial is currently suspended. In this way, the trial suspension protects the set of Final documents for astudy. Once the investigation or audit completes, the Trial Managers can revert the Trial RegistrationForm to the Active state using the Resume menu option. In the Active state, end users can continueto make additional documents Final.

In addition to suspending a trial, Trial Managers can also lock the trial using the Lock menu option.Locking a trial causes all of the documents associated with the trial as well as the Trial RegistrationForm to lock. Once locked, end users cannot edit or modify the documents. The file plan also locksbecause of this process. Locking does not prevent users from uploading additional work-in-progressdocuments, but like a suspended trial, the system prevents them from making new documents Final.

Trial Managers usually lock trials when they are complete to preserve the final set of documents.It is possible to reverse the process by unlocking the trial, if necessary, to enable further documentchanges. In the standard installation, the Unlock function is restricted to those Trial Managers whoare also members of the Controlled Document Administrators group (cd_admingroup). These TrialManagers should only use the Unlock function in exceptional circumstances.

22

Overview

Clinical Crossover DocumentsAccording to the DIA reference models, certain TMF artifacts may be shared between the TMFand Clinical Research and Development (R&D) domains. These documents are known as clinicalcrossover documents in the Life Sciences solution.

To support crossover documents, the system enables you to create clinical TMF documents inDocumentum eTMF and if Documentum R&D is installed, the system autolinks these documents tothe Clinical domain in Documentum R&D. The Documentum R&D lifecycle-related functionalitysuch as Associate Regulatory Application is enabled for these TMF documents.

If only Documentum eTMF is installed, the system does not autolink the TMF documents toDocumentum R&D. When Documentum R&D is installed, a migration utility is provided to enableexisting TMF documents to be autolinked to Documentum R&D.

Conversely, if only Documentum R&D is installed, the existing R&D clinical documents that arecrossovers are created as R&D documents, but not linked to Documentum eTMF. When TMF isinstalled, you can use the migration utility to convert the crossover documents to TMF documentsand autolink to Documentum eTMF.

Only Clinical TMF artifacts are supported. Artifacts such as Regulatory Admin documents cannot beconsidered as crossover documents. Crossover documents have the same control category in bothDocumentum R&D and Documentum eTMF. Crossover documents created in Documentum R&D areassumed to be trial-level or product-level documents in Documentum eTMF.

TMF placeholders for crossover documents are not included in Documentum R&D. Crossover onlyapplies to TMF documents. However, if a placeholder for a trial-level TMF document is versionedto create a draft 0.1 version, it becomes a TMF document and is cross-linked to Documentum R&Daccordingly.

Clinical trial registration forms can be created either in Documentum R&D or eTMF:

• If created in Documentum eTMF, the initial state of the clinical trial registration form is Planning.If TMF file planning is enabled, a file plan is provided to activate the trial. Otherwise, theregistration form can be activated without a file plan.

• If created in Documentum R&D, the initial state of the clinical trial registration form is Active withTMF file planning disabled. To enable TMF file planning, TMF must also be installed, and the stateof the registration must be reverted to Planning. Existing R&D documents are not automaticallylinked into TMF when this happens. After it is TMF-enabled, the registration form cannot beTMF-disabled and reverted back to a Documentum R&D-only trial registration form.

23

Overview

24

Chapter 2Roles

A role is a type of group that contains users or other groups that are assigned a specific role. Rolesprovide a means of defining groups that have a particular function within a system. For example,pharmaceutical companies manage their huge set of documentation the assignment of roles suchas Authors, Reviewers, Approvers, Managers, and so on. Each role can have one or more peopledesignated to perform the activity.


• Trial Managers and Product Managers, page 25

• Contributors and Investigators, page 26

• Authors and Document Coordinators, page 28

• Reviewers and Approvers, page 29

• Inspectors and Auditors, page 29

• Readers, page 30

• Administrators, page 30

Trial Managers and Product ManagersTrial Managers and Product Managers manage the documentation for their respective areas. Theycreate and manage the registration forms that users use to import and create documents. They alsomanage the placeholders for Trial Master File (TMF) documents. For example, Product Managersmanage product registration forms and Clinical Trial Managers, known as Trial Managers, manageclinical trial, country, and site registration forms. Clinical Trial Managers also set up and maintain thefile plan for clinical trials and monitor the progress of active trials.

The following table lists Trial Manager tasks and provides links to the instructions:

Task Instructions

Set up and manage registration forms Defining Information in Registration Forms,page 31

Assign users and groups to the default roles onthe registration forms

Assign Users and Groups to their Roles, page 43

Register external trial participants External Trial Participant Registrations, page 44

25

Roles

Task Instructions

Create file plans for clinical trials Creating a File Plan, page 48

Update clinical trials Updating the eTMF Structure with Changes,page 58

Monitor clinical trial progress Viewing Clinical Trial Progress, page 58

Make registration form changes that apply toexiting documents

Registration Form Changes that apply toExisting Documents, page 59

Import and export multiple documents Importing and Exporting Multiple Documents,page 83

Import and Index documents Chapter 4, Import and Index Trial Documents

Create documents Chapter 6, Create Trial Documents

View document status Viewing Document Status, page 106

Find documents using Public searches Chapter 9, Find Documents

Contributors and InvestigatorsContributors, External Contributors, and Investigators import and index Trial Master File (TMF)documents. They can use the quick action buttons on the Welcome page to import and index thedocuments. The Welcome page also contains a status that shows the number of documents thatare ready for indexing.

Contributors can browse the eTMF structure; search for placeholders, registration forms, anddocuments; drag and drop files on the placeholders; and index the files. Chapter 4, Import and IndexTrial Documents provides more information.

The following table lists Contributor, External Contributor, and Investigator tasks and provideslinks to the instructions:

Task Instructions

Search for placeholders Finding a Placeholder, page 67

Finding a Placeholder using a Public Search,page 67

Search for registration forms Finding a Registration Form, page 68

Import documents Importing to a Placeholder, page 69

Importing to a Registration Form, page 69

Index documents Indexing a Document in the Finalize IndexingList, page 70

Indexing a Document in the Doc List, page 70

Search for documents Finding a Document, page 71

Access the Investigator workspace Accessing the Investigator Workspace, page 73

26

Roles

Task Instructions

View site registration forms Viewing the Site Registration Forms, page 73

View placeholders and key documents Viewing the Missing and Key Documents for aSite, page 74

Import a document to a placeholder Importing Documents to a Placeholder, page 74

27

Roles

Authors and Document CoordinatorsAuthors create documents and submit them for collaborative editing and review. They canself-approve most TMF documents.

Documentum eTMF has a Contributor role in addition to the Author role, which only importdocuments. Authors can import documents and create documents from templates.

Document Coordinators manage the publication of controlled documents. Authors can act asDocument Coordinators on most TMF documents.

Authors and Document Coordinators monitor the progress of document workflow tasks. They canchange workflow task performers and stop the workflows.

The following table lists Author and Clinical Coordinator tasks and provides links to the instructions:

Task Instructions

Create controlled documents Creating a Document, page 76

Import and Index documents Chapter 4, Import and Index Trial Documents

Send a document for collaborative editing Launching the Collaborative Editing Workflow,page 94

Send a document for review Launching the Review Workflow, page 95

Self-approve documents Self-approving a Document, page 95

Edit a document in a collaborative editingworkflow

Editing a Document in a Workflow, page 98

Consolidate document changes from eachreviewer

Consolidating Document Changes, page 99

Review document feedback from reviewers Reviewing Document Feedback from Reviewers,page 101

Approve TMF documents in a Review workflow Approving Documents, page 102

Work with Final documents Working with Final Documents, page 103

View the document history Viewing the Audit Trail, page 97

Delete and restore a document Deleting and Restoring a Document, page 113


View workflow progress Viewing Workflow Progress, page 107

Change workflow task performers Workflow Task Performer Changes, page 108

Manage placeholders Placeholders, page 67

Viewing Placeholder Properties, page 68

Omitting a Placeholder, page 79

Reinstating a Placeholder, page 80

Find documents using Public searches Chapter 9, Find Documents

28

Roles

Reviewers and ApproversReviewers review documents using annotations and edit documents. Approvers are responsiblefor approving controlled documents. Authors can self-approve most TMF documents. ExternalReviewers peer review or collaborate during the authoring of documents. For example, an externalreviewer can be an expert in the relevant field of medicine.

Reviewers and Approvers complete workflow tasks and can browse and search for TMF documents.

The following table lists Reviewer tasks and provides links to the instructions:

Task Instructions

Performing workflow tasks Performing Tasks in a Workflow, page 95

Review and edit documents in a collaborativeediting workflow

Editing a Document in a Workflow, page 98

Review and annotate documents in a workflow Reviewing Documents in a Review Task, page100


Delegate a task to another user Delegating a Task as a User, page 110

Inspectors and AuditorsInspectors and internal Clinical Auditors have read-only access to audit logs as well as Final,Superseded, and Expired documents. They can view document content, history, and properties. TheConcurrent View enables them to compare two documents side-by-side. They can also add notes,also known as Inspector Notes, to documents.

The following table lists Clinical Inspector and Auditor tasks and provides links to the instructions:

Task Instructions

Browse and search for TMF documents Locating Documents, page 111

Compare two documents side-by-side Viewing Documents Side-by-side, page 112

Add a note, delete a note, and view notes Adding Notes, page 113

Viewing and Deleting Notes, page 113

View the document history Viewing the Document History, page 113

View document properties Viewing Documents and their Properties, page112

Export content to Microsoft Excel Export the Doc List to Microsoft Excel, page 114

29

Roles

ReadersReaders have read-only access to Final versions of documents. They browse for, search, and readdocuments. If any documents are category 1 and issue To Be Read (TBR) notifications, readers mayreceive a workflow task to acknowledge the TBR.

The following table lists Reader tasks and provides links to the instructions:

Task Instructions

Browse and search for TMF documents. Locating Documents, page 111

Performing workflow tasks Performing Tasks in a Workflow, page 95

AdministratorsAdministrators can access administrative functions, but they do not have access to controlleddocuments.

The following Administrator tasks are available in the Administration view (known as theAdministration widget):

• Administer group membership

• Administer dictionaries

• Administer taxonomies

The EMC Documentum D2 User Guide provides more information.

30

Chapter 3Set Up and Administer Trials

This section is for Trial Managers, also known as Business Administrators, who set up and administerclinical trials. It is also for Product Managers who set up and manage product registration forms.


• Defining Information in Registration Forms, page 31

• External Trial Participant Registrations, page 44

• Creating a File Plan, page 48

• Updating the eTMF Structure with Changes, page 58

• Viewing Clinical Trial Progress, page 58

• Locking a Clinical Trial, page 58

• Registration Form Changes that apply to Existing Documents, page 59

Defining Information in Registration FormsManagers have the ability to create registration forms, which model trial entities in the Trial MasterFile (TMF) system. New documents inherit specific attribute values from registration forms whenusers create or import documents in the repository. Registration forms enable users to createdocuments with consistent and accurate properties. Registration forms also correctly assign users foreach role in the workflow.

While managers have the ability to manually create registrations, most of the information suppliedin these forms is managed by other systems such as Clinical Trial Management System (CTMS) ormaster data management system. Therefore, Documentum eTMF supplies an SDK to integrateexternal systems and allow those systems to create and manage registration forms.

Registration forms are not versioned. Before using a registration form to create documents, verifythat all of the information is consistent and accurate. When you change registration form properties,the changes usually apply to the documents that users create after the change. However, ProductManagers and Trial Managers can make changes that apply to existing documents.

31

Set Up and Administer Trials

Registration forms:• Define the product codes and trial identifiers that can be selected in the document propertiesscreens in the Classification tab when a new document is created.

• Provide default metadata for the relevant documents and placeholders to inherit, which may beread-only at the document/placeholder level.

• Simplify the document creation process for the Authors by reducing data entry.

• Restrict the use of certain product codes and trial IDs to specific user groups.

• Define default role assignments to apply to the relevant documents, which can be read-only atthe document level.

• Enable the appropriate managers to control of the overall status of a product, trial, or project.

• Can disable an entire product or trial by preventing documents from being made Final.

Registration Forms, page 15 provides additional information.

The following topics describe how to create registration forms:

• Creating a Product Registration Form, page 32

• Creating a Clinical Trial Registration Form, page 34

• Creating a Clinical Trial Registration Form for Crossover Documents, page 35

• Creating a Country Registration Form, page 36

• Creating a Site Registration Form, page 37

Creating a Product Registration Form

Product Registration Forms define product codes and product-related metadata. These forms relateproducts to the appropriate product identification codes and are required to create the ClinicalTrial Registration Forms.

1. Log in as a member of the cd_product_managers group.

2. From the Browser, navigate to the Product Library and select a related Product Registration Form.

3. Select New > Content from the menu bar.

4. In the Creation profile field, select Product Management.

5. In the Document Type field, select Product Registration Form and click Next.

6. On the Edit properties page, select or type information in the fields associated with following tabs:• Product Info: Enter values to the Product Code field and the DIA Reference Model specifiedattribute information for the product.

Note: When providing product-specific information in the grid, you can leave certain fields,such as Drug Substance Name and INN, blank as the data for these fields might not beavailable when you initially create the Product Registration Form. However, when you wantto update these blank fields, you cannot update the existing row. Instead, you must create aduplicate row in the grid with the new data, as shown in the following image:

32


Use the steps provided in Changing Product-related Information for a Product, page 60 toupdate product information.

• Trial Master Files:

— Enable product-level file plan: Select to associate a predefined product-level file plantemplate with this form. This field is optional and can be set up after you create the form.

— TMF Template: If you enable a product-level file plan, select a file plan template. You canonly use a product-level file plan template that is in the Active state.

• Access Control:

— Product Managers: Add the users who can manage this registration form. Add themanagers to the to the cd_product_managers group, if necessary.

— Primary User Group: Add the groups that can author documents related to the ProductRegistration Forms. You should test the registration form before allowing users to access it.

Hover your cursor over the fields to show additional information.

7. Click Next.The system saves the form in the Product Library cabinet. The initial status is Active.

33


Related topic:

• Product Registration Form Lifecycle, page 38

Creating a Clinical Trial Registration Form

The Clinical Trial Registration Form defines clinical trial metadata, including product-relatedmetadata, which documents related to a particular clinical trial can inherit.

1. Verify that the file plan template is in the Active state if you plan to associate the Clinical TrialRegistration Form with a file plan template.

2. Log in as a member of the cd_clinical_trial_managers group.



5. In the Creation profile field, select Clinical Trial Management for eTMF.

6. In the Document Type field, select Trial Registration Form and click Next.

7. On the Registration tab, type or select information to identify the trial. The Clinical TrialIdentifier (Clinical Trial ID) is case sensitive. For example, if there is already a Clinical Trial IDnamed Abc, the system allows you to create a Clinical Trial ID named abc.

8. To associate a file plan template with the registration form, select Enable TMF file planning andin the TMF Template field, select the file plan template.

9. Verify the information on the Trial Info, Access Control, and Default Users / Groups tabs. Thesetabs inherit information from the Product Registration Form.You can specify default TMF Authors in theDefault Users / Groups tab. This setting only appliesto the Trial Master File placeholder documents generated by the system when the Clinical TrialRegistration Form is activated. The default setting for this field is cd_clinical_doc_authors, whichmeans that all members of the Clinical Document Authors group can edit and replace the contentof the system-generated TMF placeholders. You can also create an Authors sub-group for aparticular trial and configure it using this setting.

10. If you enable TMF file planning, on the Trial Master File tab:

a. Select the number of planned stages.

b. In the Time constraints area, select whether to time constrain the trial. If the trial istime-constrained, provide planned start and end dates for each stage together with a slackperiod (to allow for set up and initial document preparation). Associating a File PlanTemplate with a Trial Registration Form, page 52 provides more information.

c. If you select Staged - planned start /end dates defined for each range, select how to activatethe trial.

d. If you select more than one planned stage, in the Rollover field, select how to move to thenext stage.

e. Select the Activation Level for the TMF file plan. This controls the overall scope of the fileplan. The system ignores artifacts below the selected activation level. For example, if youselect Trial, the TMF file plan ignores country and site-level artifacts.

34


11. Click Next.The system saves the form in the Clinical Trial Library cabinet. If the directory structure doesnot exist, the system creates it. The initial status is Planning.

Related topics:

• Associating a File Plan Template with a Trial Registration Form, page 52

• Building the File Plan for the Trial, page 54

• Validating the File Plan, page 55

• Clinical Trial Registration Form Lifecycle, page 40

• Additional Menu Functions for Trial Registration Forms, page 114

Creating a Clinical Trial Registration Form forCrossover Documents

To support the creation of crossover documents, the system enables you to create a Clinical TrialRegistration Form that is common to both Documentum eTMF and Documentum R&D. Creating thisregistration form is only enabled when you have both Documentum eTMF and Documentum R&Dinstalled. You need to make additional configuration changes in D2-Config to enable crossover acrossboth solutions. The EMC Documentum for Life Sciences Installation Guide provides the configurationsteps.




4. In the Creation profile field, select Clinical Trial Management for eTMF or Clinical TrialManagement.

5. In the Document Type field, select Trial Registration Form and click Next.

6. On the Project Info tab, type or select information to identify the trial. You can select a productfrom the Product Code list. This contains a list of all products whose status is Active in therepository. Based on the selected product, a list of projects is displayed in the Project Namethat you can choose from.

7. On the Trial Info tab, type or select information to identify the trial. The Clinical Trial Identifier(Clinical Trial ID) is case sensitive. For example, if there is already a Clinical Trial ID named Abc,the system allows you to create a Clinical Trial ID named abcTo associate a file plan template with the registration form, select Generate TMF planningand in the TMF Template field, select the file plan template. Ensure that you have a File Planexisting in the system.

8. Verify the information on the Access Control, and Default Users / Groups tabs. These tabsinherit information from the Product Registration Form.

9. On the Trial Master File tab:


35


b. In the Time constraints area, select whether to time constrain the trial. If the trial istime-constrained, provide planned start and end dates for each stage together with a slackperiod (to allow for set up and initial document preparation). Associating a File PlanTemplate with a Trial Registration Form, page 52 provides more information.



e. Select the Activation Level for the TMF file plan. This controls the overall scope of the fileplan. The system ignores artifacts below the selected activation level. For example, if youselect Trial, the TMF file plan ignores country and site-level artifacts.


Related topics:


• Associating a File Plan Template with a Trial Registration Form, page 52



• Creating a Clinical Crossover Document, page 77


Creating a Country Registration Form

Clinical Trial Country Registration Forms (Country Registration Forms) register the countries whichwill have sites participating in a particular clinical trial so that you can plan and upload country andsite-specific documents for that trial. Country Registration Forms are unique to a particular trial andyou cannot reuse them across trials. For example, if you have sites in Germany participating in twoclinical trials, you will need to have two country registration forms for Germany, one for each trial.

You can add Country Registration Forms at any time, either before activating the trial or while thetrial is active. For example, you can add Country Registration Forms as the trial rolls out to new sitesin new countries. You can then register sites for each country. Creating a Site Registration Form, page37 provides additional information.


2. From the Browser, navigate to the Clinical Trial Library and select a related Trial RegistrationForm.



5. In the Document Type field, select Country Registration Form and click Next.

36


6. On the Registration tab, type or select information in the fields as needed.

7. To associate this form with a predefined country-level file plan template:

a. On the Trial Master File tab, select Use country-level TMF file plan.

b. In the TMF Template field, select the file plan template.

8. Verify the information on the Access Control tab. It inherits information from the TrialRegistration Form.


Related topic:

• Clinical Trial Country Registration Form Lifecycle, page 41

Creating a Site Registration Form

Clinical Trial Site Registration Forms (Site Registration Forms) register the sites which will participatein a particular clinical trial so that you can plan and upload site-specific documents for that trial. SiteRegistration Forms are unique to a particular trial and you cannot reuse them across trials. Forexample, if you have the same site participating in two clinical trials, you need to have two siteregistration forms, one for each trial.

You can add Site Registration Forms at any time, either before activating the trial or while the trial isactive. For example, you can add Site Registration Forms as the trial rolls out to new sites. A sitename and Principal Investigator is associated with each site to facilitate site identification.

Register the country in which the site resides before registering the site. Creating a CountryRegistration Form, page 36 provides additional information.


2. From the Browser, navigate to the Clinical Trial Library and select a related Country RegistrationForm.



5. In the Document Type field, select Site Registration Form and click Next.

6. On the Registration tab, type or select information in the fields as needed.

7. To associate this form with a predefined site-level file plan template:

a. On the Trial Master File tab, select Use site-level TMF file plan.

b. In the TMF Template field, select the file plan template.

8. Verify that the information is correct on the Access Control tab. It inherits information from theCountry Registration Form.

9. Click Next.

37


The system saves the form in the Clinical Trial Library cabinet. If the directory structure does notexist, the system creates it. The initial status is Active.

Related topic:

• Clinical Trial Site Registration Form Lifecycle, page 42

Registration Form Lifecycle Models

The lifecycles of the registration forms indicate the status of a particular product, trial, or projectdocument.

Documents referring to a product code cannot be made Final while the registration form is in theSuspended or Withdrawn state.

When a Trial Registration Forms is set to Suspended or Completed, documents associated with thattrial cannot be made Final. This provides control for Clinical Trial Managers and ensures that thecurrent set of Final documents is not modifiable while the trial registration is in these states.

Temporary suspension of a trial may be necessary on occasion if the trial is the subject of aSerious Adverse Event (SAE) investigation or audit. However, this does not necessarily preventwork-in-progress documents related to the trial from being created, reviewed, and approved in themeantime. When the trial registration is reactivated, the additional documents can then bemade Final.

• Product Registration Form Lifecycle, page 38

• Clinical Trial Registration Form Lifecycle, page 40

• Clinical Trial Country Registration Form Lifecycle, page 41

• Clinical Trial Site Registration Form Lifecycle, page 42

Product Registration Form Lifecycle

The following table describes the lifecycle states in the Product Registration Form Lifecycle Model:

The following figure illustrates the lifecycle state transitions in the Product Registration FormLifecycle Model:

38


State Description

Active Indicates that the Product is active in the system and availablefor document creation.

Inactive Indicates that the registration form is inactive in the system andnot available for users in the system. Documents referring to thisproduct code cannot be made Final while the Product RegistrationForm is in the Inactive state.

39


Clinical Trial Registration Form Lifecycle

Documents referring to this trial registration cannot be made Final while the Trial Registration Formis in the Suspended, Completed, or Locked states.

Trial Registration Form Lifecycle Model, page 21 provides detailed information.

The following figure illustrates the lifecycle state transitions in the Clinical Trial Registration FormLifecycle Model (Trial Registration Form Lifecycle Model):

The following table describes the lifecycle states in the Clinical Trial Registration Form LifecycleModel:

State Description

Active Indicates a trial has been planned and activated by the trialmanager. Documents can be processed and made Final.

40


State Description

Completed Indicates a trial or project that has finished (no longer active).

Planning This is the initial lifecycle state for a Clinical Trial RegistrationForm. While the registration form is in this state, the TrialManagers can enable TMF file planning and pre-configure the fileplan templates using the Trial Planning lifecycle menu function.When ready, they use the Activate lifecycle menu function toactivate the trial, which prompts the user to confirm or adjust theplanned start dates, end dates, and slack periods, then launchesthe template reconciliation process.

Initializing Indicates a transient state that the TMF template constructionprocess is running in the background.

Suspended Indicates a trial that was suspended for some reason, such as aSerious Adverse Event (SAE) report that is being investigatedor a manufacturing issue. Registration Form is in a frozen state.Documents relating to the trial can still be prepared, but cannotbe made Final. Consequently, the current set of Final documentsis protected from further changes.

Locked Locks a clinical trial to prevent changes to and uploading of TMFdocuments.

Clinical Trial Country Registration Form Lifecycle

Documents referring to this country code cannot be made Final while the Clinical Trial CountryRegistration Form is in the Inactive state.

The following figure illustrates the lifecycle state transitions in the Clinical Trial Country RegistrationForm Lifecycle Model:

41


The following table describes the lifecycle states in the Clinical Trial Country Registration FormLifecycle Model:

State Description

Active Indicates a country has sites which are participating in the trial.The registration form is in an active state. Documents can beprocessed and made Final.

Inactive A frozen state, documents relating to the country can still beprepared, but cannot be made Final. The current set of Finaldocuments is protected from further changes.

Clinical Trial Site Registration Form Lifecycle

Documents referring to this site code cannot be made Final while the Clinical Trial Site RegistrationForm is in the Inactive state.

The following figure illustrates the lifecycle state transitions in the Clinical Trial Site RegistrationForm Lifecycle Model:

The following table describes the lifecycle states in the Clinical Trial Site Registration Form LifecycleModel:

State Description

Active Indicates a site is participating in a trial. The registration form isin an active state. Documents can be processed and made Final.

Inactive A frozen state, documents relating to the site can still be prepared,but cannot be made Final. The current set of Final documents isprotected from further changes.

42


Restricting Access to Registration Forms

Administrators can restrict access to Registration forms using the following methods:• Control user access: Restrict access to registration forms by creating specific group forms forthe appropriate functional area group. For example, set up a confidential trial that consists ofdocuments visible to a new group with specified users. Then define this group as the ClinicalTrial Managers on the Access Control tab of the Trial Registration Form. Only these users canview the registration form and create documents that refer to this trial. Additional restrictionscan also be imposed by changing the lifecycle state of the form.

• Control lifecycle states: By changing the lifecycle status of a registration form, administratorscan preserve the current set of Final documents relating to a particular product, trial, or project.The project, trial, or entire product line is frozen when the associated registration forms in oneof these states.— Clinical Trial Registration Form: Restrict access to a Trial Registration Form by changing thestatus of the form to Halted or Completed. Documents referring to a particular Trial cannot bemade Final while the Trial is in a Halted or Completed state.

— Product Registration Form: Restrict access to a Product Registration Form by changing thestatus of the form to Inactive. Documents referring to a particular Trial Registration Formcannot be made Final while the Product Registration Form is in a Inactive state.

While the registration form remains frozen, users can create, review, and approve documents.However, users cannot release the documents to an Final state until the appropriate registrationforms are reverted to an Active state.

Assign Users and Groups to their Roles

Use this procedure to change the default users and groups assigned to the roles on the Clinical Trial,Country, or Site Registration Forms.

Log in as a member of the cd_clinical_trial_managers group.

1. Right-click a Clinical Trial, Country, or Site Registration Form and select Properties.

2. On the Default Users / Groups tab, select the users and groups for the default roles that appearwhen users create documents that refer to this registration form. For example, On the Reviewerstab, select the default users and groups responsible for reviewing the documents created withthis registration form. Authors can adjust these settings when they create documents.

3. Click OK.

43


External Trial Participant RegistrationsManagers can give external trial participants TMF access at the site and country levels by adding themto the relevant registration forms at those levels. Registering participants at the site level providesaccess to the documents and placeholders for that site, as well as the documents and placeholdersfor the country, trial, and product associated to the site. Registering participants at the country levelprovides access to the documents and placeholders for that country, all sites registered for thatcountry, and to the trial and product documents and placeholders to which the country is registered.

External trial participant roles include inspectors, investigators, external contributors, and externalreviewers. Administrators can define additional roles, if necessary. The document access for aparticular role depends on the registration form used to provide the access:

• Site-level registration form: Provides access to the documents and placeholders for that site, aswell as the documents and placeholders for the country, trial, and product associated to the site.

• Country-level registration form: Provides access to the documents and placeholders forthat country, all sites registered for that country, and to the trial and product documents andplaceholders to which the country is registered.

You can also limit the duration of the access for external trial participants. You can define when theaccess begins and when it expires. For example, in preparation for an inspection, a clinical trialmanager adds an inspector for a specified time for a set of studies.

When a clinical trial manager activates a site or country registration form, the system automaticallycreates a hierarchy of access control groups for the external trial participants.

44


The following figure illustrates the access control group hierarchy for external trial participants:

The system only adds users to a participant role group if their registration is valid as defined bythe registration form manager. The registration form and its associated trial registration form, ifapplicable, must also be active. If a trial registration form is no longer active, such as when it is in aPlanning state, the system revokes access to all participants. If the trial registration form reactivates,the groups repopulate to reinstate access.

Related topics:

• Security Considerations for Internal and External Users, page 45

• Giving Access to External Trial Participants, page 46

• Verifying External Trial Participant Access, page 47

Security Considerations for Internal and External Users

Trial Managers can add internal users as external trial participants for a particular site or country.When trial managers grant internal users additional access rights as external trial participants,Documentum security grants the users the highest level of security. For example, if an internal userwith Read access becomes an External Contributor for a specific site, the user has Read access toeverything and receives Write access to specific site documents and to country, trial, and productdocuments related to that site.

45


The system automatically sends an email notification to the Trial Manager of the associatedtrial whenever an external participant is enabled or disabled for that trial. To receive the emailnotifications, you must have the SMTP server integrated with Documentum.

Giving Access to External Trial Participants1. Log in as a member of the cd_clinical_trial_managers group.

2. Locate a site-level or country-level registration form for a particular trial. The selected countryor site registration form must be in the Active lifecycle state.

3. Right-click the registration form and selectManage External Participants.

4. Complete the external participant information as defined in the following table:

Column Description

User Name Begins Enter the first few letters of the user name tofilter your selection options in the User Namefield.

User Name Select the Documentum user name of theparticipant for the selected registration form.

Full name Displays the real-life name of the selectedDocumentum user.

Email Address Displays the email address of the participant.

Role Select the role of the participant for thecountry or site.

Valid From (Optional) Select the date that the access of theparticipant begins.

Valid To (Optional) Select the date that the access of theparticipant expires.

Enable Select the checkbox to enable system access forthe participant as specified in the country orsite registration form.

Clear the checkbox to remove access for theparticipant.

Status Displays whether the participant is currentlyenabled in the system. If the participant isenabled in the system, the status is Active. Ifthe participant is not enabled in the system,the status is Inactive.

5. To add another participant below another participant, right-click a row and select Insert row. Toremove a participant, right-click a row and select Delete row.

6. To provide access to documents for another site or country repeat this procedure using a relevantsite or country registration form.

46


7. Click OK.

8. Right-click the registration form again and selectManage External Participants. Verify that thestatus of the participants is correctly set to Active or Inactive in the Status column.

Related topic:

• Verifying External Trial Participant Access, page 47

Verifying External Trial Participant Access1. Log in as a member of the cd_clinical_trial_managers group.

2. Browse or search for a country-level or site-level registration form for a particular trial.

3. Right-click the registration form and selectManage External Participants.

4. In the Status column, verify that the status of the participants is correctly set to Active or Inactivein the Status column.

5. Adjust the participant settings as required.

6. Click OK.

7. If you changed participant access settings, right-click the registration form again and selectManage External Participants. Verify that the updated statuses appear correctly as Active orInactive in the Status column.

47


Creating a File PlanA Trial Master File (TMF) is a compilation of essential documents that get collected as a clinicaltrial progresses in order to ensure regulatory compliance. A file plan enables you to specify therelevant document types (artifacts) that users should provide at each stage of the clinical trial. The fileplan also enables you to define a hierarchical file structure and metadata for the documents at thefollowing levels in the TMF structure:

• Product

— Trial

— Country

— Site

After you create and activate the file plan, it automatically creates the hierarchical file structure andthe document placeholders for all active stages within the file structure. Contributors and Authorscreate and import documents and associate them to the placeholders. TMF system properly names,files, and secures the documents.

A file plan is always associated with a clinical trial and is stored as a Microsoft Excel file of the TrialRegistration Form. Depending on the configuration, the file plan can cover all of the levels in thefile structure (Product, Trial, Country, and Site) by using TMF templates. TMF templates, knownas file plan templates, associate with registration forms at one or more levels in the hierarchicalstructure to update and maintain the file plan.

File Plan Templates are Microsoft Excel spreadsheets that contain the TMF Taxonomy (Schema) thatenables you to select and plan the document types for the trial. The system compiles the file plan fromfile plan templates starting with the product-level file plan template (if there is one), followed by thetrial-level file plan template, any country-level file plan template, and any Site-level file plan template.

A file plan should have at least one file plan template defined at the Product or Trial level. In mostsituations, you create a file plan from either a product-level file plan template or a trial-level file plantemplate:

• Product-level file plan template: Defines artifacts that should apply to all trials related to aparticular product. You can require or recommend specific artifacts at the product level to ensurecompliance with business rules or practices. You can redefine recommended product artifacts atthe trial, country, and site levels when necessary.

• Trial-level file plan template: Defines artifacts for an individual trial. If you have multiple trials,consider creating multiple trial-level file plan templates to define common artifacts for differenttypes of trials. You can then select the appropriate trial level template when creating a file planfor a trial.

File Plans, page 13 provides detailed information.

Complete the following procedures to create a file plan from a product-level or trial-level file plantemplate:

• Creating a File Plan Template, page 49 (Create a file plan template at the product level or triallevel.)

• Activating the File Plan Template, page 51

• Creating Registration Forms for the Trial, page 51

48


• Associating a File Plan Template with a Product Registration Form, page 52 (For a product-levelfile plan template)

• Associating a File Plan Template with a Trial Registration Form, page 52 (For a trial-level fileplan template)



• Adjusting the Trial Schedule, page 55

• Activating the Trial, page 56

Creating a File Plan Template

A file plan should have at least one file plan template defined at the Product or Trial level. In mostsituations, you create a file plan from either a product-level file plan template or a trial-level file plantemplate.




4. In the Document Type field, select Template File Plan and click Next.

5. In the Level field, select the level that the template applies to in the file structure.

6. In the Template Name field, type a name for the file plan template. The file plan templateapplies to all trials.

7. On the Access Control tab, verify the default access. It restricts access to the file plan.

8. Click Next, select the File Plan Sample Spreadsheet, and then click Next.

9. If requested, select a folder on your local file system for your checked out content on the localfile system.

10. On the File Planworksheet of the blank TMFMaster Template Microsoft Excel spreadsheet, selectinformation from the drop-down lists as described in the following table:

File Plan Column Name Description

Stage (Optional) Leave this field blank or select a relevantstage number. You can use up to five stages.

You can assign each row to a stage. When activatingthe trial, you get an option to activate the stages. Youcan activate the stages incrementally or in parallel.

Artifact Name Unique artifact name as defined in the taxonomy.

Inclusion Rule Shows whether the artifacts are required,recommended, or optional.

49


File Plan Column Name Description

Scope Shows the level in the hierarchical file structure(product, trial, country, or site) for each artifact. If youselect All Countries or All Sites, the system creates aunique placeholder for each country or site registeredfor the trial.

Country (where applicable) This field is only used when the Scope field is SpecificCountry.

Site (where applicable) This field is only used when the Scope field is SpecificSite.

Repeatable? • Select Y (Yes) to allow more than one document forthe placeholder.

• Select N (No) to allow only one document for theplaceholder.

Expected # docs (per location) Minimum number of documents expected for theplaceholder to be regarded as complete:

• If Repeatable is No and this field is 0, the artifact isconsidered optional. If Repeatable is Yes and thisfield is 0, the artifact is considered infinitemeaningthat the system never removes the placeholder andthe artifact shows asmissing until the placeholder isomitted. Select 0 for optional documents.

• Select 1 or more for repeatable required documents.

Can be overridden • Select Y (Yes) to allow users to redefine this artifactin a lower-level file plan template.

• Select N (No) to prevent users from redefiningthis artifact. In that case, users can contact theappropriate manager to make changes.

11. Do not update the columns to the right of the Can be overridden? column. The system uses theValidity, Locations, Status, and Source columns to record validation errors, placeholder counts,current progress, and template source origin information.

12. Do not update the Schema worksheet. The system automatically updates the schema. Theinformation in the drop-down lists on the File Plan worksheet comes from the schema.

13. Save the Microsoft Excel Spreadsheet in Microsoft Excel 97-2003 format (.xls format).

14. On the Check in page, click Check In and Finish. The file plan template has a status of Planning.The system saves the file plan template in the Clinical Trial Library/Templates folder. Userscannot use the file plan template until it is set to Active.

50


File Plan Template Activation

You can only use file plan templates in the Active lifecycle state. This enables you to edit and reviewthem before making them active.

Only one version of a file plan template can be Active at any time. If you edit the Active version andcheck-in the changes to create a new version, your new version reverts to the Planning state. Thesystem uses the previous Active version until the next version becomes Active, at which point theprevious Active version becomes Superseded. The system always uses the latest Active version ofthe file plan template.

You associate the file plan template with a registration form at the same level in the hierarchicalstructure. Registration forms hold attributes values that documents inherit. Your file plan templatemust have an Active version before you can associate it with a registration form.

You can withdraw a file plan template at any time. The system withdraws all versions when youdo this, including the currently Active version.

Trial Activation using File Plan Templates, page 16 provides additional information.

Activating the File Plan Template1. In the Browser, navigate to the Clinical Trial Library/Templates folder and locate the file plan

template.

2. To activate the file plan template, right-click the file plan template and select Activate. SelectYes to confirm.To withdraw the file plan template at any time, right-click the file plan template and selectWithdraw.

Creating Registration Forms for the Trial

Create trial and product registration forms for the trial. Country and site registration forms areoptional. You must associate at least one file plan template with the Product Registration Form or theClinical Trial Registration Form. You do not have to associate file plan templates at the lower levels(Country Registration Form and Site Registration Form). If you associate file plan templates at thelower levels, the file plan templates merge together to update the file plan.

51


1. Create a Product Registration Form. Creating a Product Registration Form, page 32 providesinstructions.• If you have a Product-level file plan template, associate it with the Product RegistrationForm. Associating a File Plan Template with a Product Registration Form, page 52 providesinstructions.

2. Create a Clinical Trial Registration Form. Creating a Clinical Trial Registration Form, page 34provides instructions.• If you have a trial-level file plan template, associate the trial-level file plan with the ClinicalTrial Registration Form. Associating a File Plan Template with a Trial Registration Form, page52 provides instructions.

3. Create a Clinical Trial Country Registration form (optional). It is not necessary to associate it witha file plan template. Creating a Country Registration Form, page 36 and Associating a File PlanTemplate with a Country Registration Form, page 53 provide instructions.

4. Create a Clinical Trial Site Registration form (optional). It is not necessary to associate it witha file plan template. Creating a Site Registration Form, page 37 and Associating a File PlanTemplate with a Site Registration Form, page 54 provide instructions.

Trial Activation using File Plan Templates, page 16 and Registration Forms, page 15 provide moreinformation.

Associating a File Plan Template with a ProductRegistration Form

To use TMF file planning, associate at least one file plan template at the product or trial level (ProductRegistration Form or Clinical Trial Registration Form). If you have a product-level file plan template,associate it with a Product Registration Form.

1. Right-click a Product Registration Form and click Properties.

2. On the Trial Master Files tab of the Edit Properties page, select Enable product-level file plan.

3. In the TMF Template field, select the product-level file plan template.

4. If you are unable to select the product-level file plan template as expected in a registration form,on the Doc List for the file plan template, verify that the status is Active.

5. Click OK.

Associating a File Plan Template with a TrialRegistration Form

To use TMF file planning, associate at least one file plan template at the product or trial level (ProductRegistration Form or Clinical Trial Registration Form). If you do not have a product-level file plantemplate defined, associate the trial-level file plan template with a Clinical Trial Registration Form.

1. Right-click a Clinical Trial Registration Form and select Properties.

52


2. On the Registration tab, select Enable TMF file planning.

3. In the TMF Template field, select the trial-level file plan template.

4. On the Trial Master File tab:


b. In the Time constraints field, select whether to time constrain the trial.• If the trial is time-constrained, you can provide planned start and end dates for each stagetogether with a slack period (to allow for set up and initial document preparation). Thesystem determines whether or not trial progress is on track based on the elapsed timeand it assigns condition codes:— Green: On track

— Amber: Close to limits (slight risk)

— Red: Behind schedule (serious risk)

Condition codes appear in the eDRG reports.

• If the trial is not time-constrained, you do not enter planned start and end dates. Thesystem measures progress in terms of the number of documents completed compared tothe number expected, but it does not assign a condition code.



e. Select the Activation Level for the file plan template. This controls the overall scope of thefile plan. The system ignores artifacts below the selected activation level. For example, if youselect Trial, the file plan template ignores country and site-level artifacts.You can change the activation level at any time. For example, you can change the activationlevel to Site to increase the scope of the trial to include country and site-level artifacts.

5. Click OK.

Associating a File Plan Template with a CountryRegistration Form1. Right-click a Clinical Trial Country Registration Form and click Properties.

2. On the Trial Master File tab, select Use country-level TMF file plan.

3. In the TMF Template field, select the country-level file plan template.

4. Click OK.

53


Associating a File Plan Template with a Site RegistrationForm1. Right-click a Clinical Trial Site Registration Form and click Properties.

2. On the Trial Master File tab, select Use site-level TMF file plan.

3. In the TMF Template field, select the site-level file plan template.

4. Click OK.

Building the File Plan for the Trial

The file plan building process compiles a file plan from the relevant file plan templates and discardsthe current file plan if there is one. You can preserve a copy of the current file plan for futurereference. To do this, check out the Clinical Trial Registration Form and check it in again to createanother version before using this function.

1. Right-click the Clinical Trial Registration Form, select Load File Plan, and click Yes.This copies the file plan templates to the file plan.

2. Right-click the file plan for the Clinical Trial Registration Form and select Edit. Add additionalartifacts as needed.


4. Check in the modifications to the repository either to make a new version or to replace the currentversion of the Clinical Trial Registration Form.

File Plan Validation

Before activating a file plan, you should validate the file plan to ensure that the entries in the fileplan are correct, consistent, and that required settings are not missing. Validation also updates thevalue assistance in the file plan spreadsheet to ensure that country codes, site IDs, and artifact namelists are correct. If you have recently added country or site registrations to the trial, re-validate thefile plan to make it current.

When validating a file plan, the system records the results in the validation Status column of thefile plan spreadsheet.

File Plans, page 13 provides more information.

Related topic:


54


Validating the File Plan1. Right-click the file plan for the Clinical Trial Registration Form, select Validate, and click Yes.

2. Right-click the file plan and select Edit. Review the validations on the File Plan worksheetand make any necessary changes.

3. Save theMicrosoft Excel Spreadsheet in Microsoft Excel 97-2003 format (.xls format).Check in the modifications to the repository either to make a new version or to replace the currentversion of the Clinical Trial Registration Form.

Adjusting the Trial Schedule1. Right-click the Clinical Trial Registration Form and select Adjust Schedule.

2. In the Clinical Trial Schedule dialog box, review and adjust the trial activation settings includingthe Planned Start Dates and the Planned Completion Dates as required.

3. Click OK.Trial Schedule Adjustments, page 20 provides information on setting the trial schedule.

Activating the File Plan for a Clinical Trial

Activating the file plan for a clinical trial activates the trial. Activating the trial causes the system tocreate placeholders for the artifacts specified in the file plan. The placeholders are in the Required,Recommended, or Optional lifecycle state depending on the inclusion rule set when creating the fileplan. Each placeholder contains a copy of the relevant template document and has version 0.0. Theversion 0.0 indicates that the document is a placeholder. When there is no available content templatefor an artifact, the system creates the placeholder as an object without content.

The reconciliation process generates placeholders for missing and repeatable artifacts as needed andexamines the existing placeholders and documents in the TMF folder structure to determine whethereach item is reconciled, redundant, or duplicated:• Reconciled: A placeholder is considered reconciled if it is non-repeatable and a separatenon-placeholder document exists with the same artifact number, trial ID, country code, and siteID. In that case, the system automatically deletes the placeholder.

• Redundant: A non-placeholder document is considered redundant if the artifact is designatedas Not Required for the current or preceding stages in the TMF template configuration or isnot referenced at all in any stage.

• Duplicated: A non-placeholder document is considered duplicated if another non-placeholderdocument exists with the same trial ID, artifact number, country code, and site ID that was createdbefore it. They system only counts the first instance in progress reports.

The system continually monitors progress against the file plan. While the trial is active, the currentprogress details update automatically by the system on a daily basis. You can also force an updateon demand at any time using the Refresh menu option. The system records progress in the Statuscolumn of the file plan spreadsheet. You can also use the Progress Summary menu option to view theprogress of the trial.

55


Progress Tracking, page 18 provides additional information.

Related topic:

• Activating the Trial, page 56

Activating the Trial1. Right-click the clinical trial registration form and select Activate.

2. Click Yes to confirm the trial activation.The system creates placeholders in the Clinical cabinet as defined in the file plan. The file planshow a status of Initializing and then changes to Active.

eTMF Folder Structure

Documentum eTMF uses a default folder structure using the zones and sections as defined by theDIA TMF Reference Model Version 2.0. At each level (Product, Trial, Country, and Site) the zone andsection folders are created.

TMF Structure, page 10 provides detailed information.

When a placeholder document is checked-out, edited, and checked-in, the next version is checked-inautomatically as version 0.1 and is reset to the Draft lifecycle state. The document can then continueto be edited, reviewed, approved, and made Final, according to its Control Category. Placeholderscan also be deleted and reverted to the initial placeholder version 0.0 by a system administrator.For Clinical documents, each Control Category 1–3 document that is a TMF artifact should bepreconfigured in the relevant Documentum D2 creation matrix. Control Category 4 documentsshould not be used in TMFs.

56


The default folder structure is:

Product-level TMF Placeholders and Documents

Product-level TMF placeholders and documents can potentially be shared across multiple trials. Ifa product-level placeholder is marked as Not Required in the file plan for a particular trial, or thefile plan entry is removed from the file plan, the system only deletes the placeholder itself if othertrials do not reference it. Likewise, if a trial is reset from Active to Planning, the system deletes alltrial-specific placeholders (at or below the trial level), but product-level placeholders used in that trialare only deleted if they are not in use in other trials.

The system tracks this by establishing relations (dm_relation links) between the Clinical TrialRegistration Form and the product-level placeholders it uses. This happens automatically when

57


the trial activates or refreshes. You can view these relations by selecting an active Clinical TrialRegistration Form and clicking the Relations tab.

Updating the eTMF Structure with ChangesAfter changing the file plan, you can start the file plan reconciliation process to update the eTMFfolder structure and placeholders.

1. Right-click the clinical trial registration form that contains the file plan and click Refresh.

2. In the Confirmation dialog box, click Yes to reprocess the file plan.The registration form status changes to Refreshing while the update is in progress. The systemadjusts the eTMF structure and placeholders in the Clinical cabinet as defined in the file plan.When the update is complete, the status changes to Active.

3. To check the validity of the file plan, right-click the file plan again and click View.Related topic:

• File Plan Validation, page 54

Viewing Clinical Trial Progress1. Log in as a Trial Manager.

2. To update the trial information, right-click the clinical trial registration form, click Refresh, andthen click Yes.

3. Right-click the clinical trial registration form and select Progress Summary. The ProgressSummary shows current information about the trial. Progress Tracking, page 18 provides moreinformation.

Locking a Clinical TrialLock a clinical trial to prevent changes to TMF documents after closing the trial.

1. Log in as a Trial Manager.

2. In the Browser, navigate to the clinical trial registration form that contains the file plan.

3. Right-click the file plan and select Lock. Users cannot edit properties or content for the clinicaltrial.

58


Registration Form Changes that apply toExisting DocumentsWhen users create documents or the system creates placeholders, the documents and placeholdersinherit attribute values from the registration form. When you change registration form properties,the changes only apply to new documents or placeholders that are created after the change. Forcompliance purposes, this is the default behavior. However, in some situations, it may be necessaryto apply changes to registration form properties down to the existing documents and placeholders.For example, if you change the product code for a product, the change should affect not just newdocuments but also existing documents and placeholders for that product.

Documentum eTMF enables Product Managers and Trial Managers to make the following changesthat apply to existing documents:

• Changing a Product Code for a Product, page 59

• Changing Product-related Information for a Product, page 60

• Changing Clinical Trial Information, page 60

• Moving Trial Documents to a Different Product, page 61

• Changing the Location of a Site, page 61

• Changing the Name of a Site, page 62

• Associating Multiple Products with a Clinical Trial, page 63

These functions are restricted to the registration form managers.

Note: There are no predefined rules governing the conventions for product codes and trial IDs due tovarying customer requirements. Administrators can constrain these fields through regular expressionpattern matching in D2-Config as necessary. For example, Administrators can customize these fieldsto alphanumeric only plus certain characters such as underscores, hyphens, and spaces based on theirrequirements. The EMC Documentum D2 Administration Guide provides more information.

Changing a Product Code for a Product

Use this procedure to reassign an existing product to a new product code. The change affects not onlythe Product Registration Form, but also all of the documents associated with the existing productcode, including historical versions. It also affects the Clinical Trial, Country, and Site RegistrationForms associated with the product.

1. Log in as a Product Manager.

2. Right-click a product registration form with a status of Active and select Change Product Code.

3. In the Change Product Code dialog box, type the new product code. Product codes are casesensitive. For example, if there is already a product code named Emc, the system allows you tocreate a product code named emc.

4. Select Click Here to Validate. Review the validation result.

59


5. To modify the product code, clear the Click here to validate checkbox and repeat from theprevious step.

6. When you are ready to apply the change, click OK. This procedure updates the relateddocuments and registration forms to refer to the new product code, including historic versionsof these objects.

Changing Product-related Information for a Product

As users create product-related documents, the documents and placeholders automatically inheritproduct-related metadata from the relevant Product Registration Form, such as Compound IDs,Trade Names, and Generic Names. Use this procedure to update this product information and applythe changes to the relevant documents and placeholders.

This procedure affects only current versions of the documents. In order to preserve a record ofthe product information that was in force during document creation, the system does not affecthistoric versions.

1. Log in as a Product Manager.

2. Right-click a product registration form with a status of Active and select Update Product Info.

3. In the Change Product Information dialog box, make the necessary changes and click OK.The system applies these settings to the relevant documents and registration forms. Thisprocedure does not affect historic versions of these objects.

Changing Clinical Trial Information

Similar to changing product information, use this procedure to change trial-related information inthe clinical trial registration form. The system applies these settings to the relevant documents andplaceholders. This procedure does not affect historic document versions.

60



2. Right-click a clinical trial registration form with a status of Planning, Active, or Completed,and select Update Trial Info.

3. In the Change Clinical Trial Information dialog box, make the necessary changes and click OK.

Moving Trial Documents to a Different Product

Use this procedure to move a trial and its associated documents, placeholders, and registrationforms to a different product.


2. Right-click a clinical trial registration form with a status of Planning, Active, or Completed, andselect Reassign to Product.

3. In the Reassign clinical trial documents to a different product dialog box, select the newproduct code.

4. To reassign the trial to the selected product, select Click here to confirm the operation.

5. When you are ready to apply the change, click OK. The system applies these settings to therelevant documents and registration forms. This procedure affects historic versions of theseobjects.

Changing the Location of a Site

Use this procedure to associate a site with a different country.

1. Log in as a Trial Manager or a clinical trial site registration form manager.

2. Right-click a clinical trial site registration form with a status of Active and select Change SiteLocation.

3. In the Reassign a site to a different country dialog box, select the new country (and state, ifapplicable) and click OK.

61


The system updates the site-level documents to refer to the new country. The system alsorenames site-level TMF documents and placeholders. These updates do not affect historicversions of these documents.

Changing the Name of a Site

Use this procedure to change the site name, which is the description of the site. It does not changethe internal site code.

1. Log in as a Trial Manager or a clinical trial site registration form manager.

2. Right-click a clinical trial site registration form with a status of Active and select Change SiteName.

3. In the Rename site dialog box, type the site name and select Click here to validate. Reviewthe validation result.

62


4. To modify the site name, clear the Click here to validate checkbox.

5. When you are ready to apply the change, click OK. The system updates the site-level documentsand placeholders to refer to the new site name. The system also renames site-level TMFdocuments and placeholders. These updates do not affect historic versions of these documents.

Associating Multiple Products with a Clinical Trial

A clinical trial or study is associated with a single primary product, but can also be associated withother products. This is because there may be other products that the trial or study references oruses. By associating multiple products to the trial, users can access documents that are associatedwith other trials.


2. Right-click a clinical trial registration form with a status of Active and select Associate SecondaryProducts.

3. In the dialog box, in the Secondary Product List field, add the product codes that you want toassociate with the trial. You can also remove product codes that are no longer used or referencedby the documents in the study from the list.

4. To validate the change, select Click Here To Validate. If the validation results are invalid, theNeeded Studies field lists all the products that should be associated with the trial.

5. If the changes are valid, click OK.

63


64

Chapter 4Import and Index Trial Documents

This section is for Contributors, Authors, Trial Managers, External Contributors, and Investigatorswho import and index trial documents.


• Import and Indexing Process, page 65

• Placeholders, page 67

• Finding a Placeholder, page 67

• Finding a Placeholder using a Public Search, page 67

• Viewing Placeholder Properties, page 68

• Finding a Registration Form, page 68

• Import Documents, page 69

• Indexing a Document in the Finalize Indexing List, page 70

• Indexing a Document in the Doc List, page 70

• Finding a Document, page 71

Import and Indexing ProcessImporting documents into the Trial Master File (TMF) structure in the Documentum repositoryis a two-step process:

• Import: Import documents from your computer into the repository.

• Index: View the document content and compare it with the information in the documentproperties. Select and verify the document information and then save the document properties.

When importing TMF documents, the system considers the role of the user, that is, the user isa member of the clinical_doc_contributor or cd_clinical_doc_authors_tmf (a subgroup undercd_clinical_doc_authors) group.

After you import the documents, the documents have a status of Index, which means that they areready to index. After you index, verify, and save the document information, the status changes toFinal. Documentum eTMF automatically files the documents in the correct location in the TMFstructure based on the indexing selections.

65

Import and Index Trial Documents

The system sends email notifications on a daily basis to the contributors of the documents withthe Index status listing the documents that need to be indexed. The message includes hyperlinksfor each document that needs indexing; clicking a document hyperlink locates the document in theDoc List. The notifications are generated through a Documentum job that is scheduled to triggeron a daily basis. To receive the email notifications, you must have the SMTP server integrated withDocumentum.

Documentum eTMF uses the following import and indexing process for TMF Documents:

The following table describes the ways that you can import files:

Import type Description

Import button on Welcome page You can import files directly from the Welcome page byclicking the Import button. Document properties are emptyupon completion of the import.

Import to Placeholder You can locate a placeholder for a document and then dragand drop the document onto the placeholder (or select theplaceholder and select Import > File from the menu). Thesystem automatically populates the document properties withinformation from the placeholder.

Import to Registration Form You can locate a registration form for a document and thendrag and drop the document onto a registration form (or selectthe registration form and select Import > File from the menu).If you have multiple documents of different types associatedto the same product, trial, country, or site, you can importto a registration form and then index the document-specificinformation later. The system automatically populates thedocument properties with information from the selectedregistration form.

66


PlaceholdersWhen a trial activates, the system creates placeholders for the documents specified in the file plan.There are three types of placeholders:

• Required: Documents must be created for this placeholder. These documents are required andmust be final to complete the eTMF.

• Recommended: Documents should be created for this placeholder and made final to complete theeTMF. You need to provide a reason to remove this type of placeholder from the eTMF.

• Optional: Documents can be created for this placeholder and made final. These documents arenot required to complete the eTMF.

Placeholders have a version of 0.0. The Status column in the Doc List shows the type of placeholder.

The system automatically removes placeholders as users create or import content for them. If aplaceholder has more than one expected document, the placeholder remains to enable the importof additional documents. Each document created for a placeholder receives a unique sequencenumber, appended to the artifact number.

After receiving the expected number of documents, the system removes the placeholder. If a userdeletes a document, the corresponding placeholder regenerates automatically when the trial isrefreshed.

Finding a Placeholder1. Log in as a Contributor.

2. Click Browse & Search.

3. Click Find Documents.

4. In the Choose field, select Find Placeholders.

5. Select the document Scope (level within the TMF structure), and then select a trial, country, or site.

6. Click Run. The placeholders appear in the Doc List.

Finding a Placeholder using a Public Search1. Log in as a Clinical Author, Contributor, or Trial Manager.

2. Click Browse (Author or Trial Manager) or Browse & Search (Contributor)

3. Click Search.

4. In the Searches > Public Searches folder, double-click the Find Clinical Trial Documents orPlaceholders search query.

5. In the Choose field, select Find Placeholders.

6. In the Query Form dialog box, select the document Scope (level within the TMF structure) andthen select a trial, country, or site.

67


7. Click Run.

Viewing Placeholder PropertiesThe properties of a placeholder provide information on the documents expected and completedfor that placeholder.

1. In the Doc List, right-click a placeholder and select Properties.

2. On the Classification tab, notice the following placeholder properties as described in thefollowing table:

Field Description

TMF Inclusion Shows the placeholder type.

Number of documents expected Shows the number of documents expectedfor this placeholder. Optional placeholdershave a value of 0 (zero) and you can uploadany number of documents for optionalplaceholders.

You can change the expected number ofdocuments, if necessary.

Number of documents completed Shows the number of documents that arecurrent and in the Final state.

Finding a Registration Form1. Log in as a Contributor.


3. Click Find Registrations.

4. Select an optional filter or leave the fields blank to find all registration forms.

5. Click Run.

68


Import DocumentsThis section contains the following topics:

• Importing from the Welcome Page, page 69

• Importing to a Placeholder, page 69

• Importing to a Registration Form, page 69

Importing from the Welcome Page1. Log in as a Clinical Author (cd_clinical_doc_authors_tmf) or Contributor.

2. On theWelcome page, click Import.

3. On the Select files page, select one or more documents to import from your local file systemand the file format.

4. Select Same creation profile for all files and click Next.

5. The uploaded document is ready for indexing and appears on the QC & Index view in theFinalize Indexing area with a status of Index.

Importing to a Placeholder1. In the Doc List, select a placeholder.

2. Drag and drop one or more documents from your computer onto the placeholder. Alternatively,select Import > File from the menu and select the documents to import by navigating yourfile system.

3. On the Select files page, select the document to import from your local file system and thefile format.

4. Select Same creation profile for all files and click Next. The file automatically inherits therelevant properties of the placeholder. The uploaded document is ready for indexing and appearsin the Finalize Indexing area with a status of Index.

Related topic:


Importing to a Registration Form1. In the Doc List, select a registration form.

2. Drag and drop one or more documents from your computer onto the registration form.Alternatively, select Import > File from the menu and select the documents to import bynavigating your file system.

69



4. Select Same creation profile for all files and click Next.

5. The file automatically inherits the relevant properties of the registration form. The importeddocument appears in the Finalize Indexing list. The document has a status of Index, a version of0.1, and is ready for indexing.

Related topic:


Indexing a Document in the Finalize IndexingList1. In the Finalize Indexing list, select a document.

2. In the Document Viewer, review the document content.

3. If you did not select a placeholder before importing the document, do the following:

a. In Edit Properties, select a scope (level within the TMF structure) and the details required forthe document.

b. In the Name Contains field, start typing the name of the placeholder.

c. In the Placeholder field, select the placeholder for the document.

4. Verify the information and click Save. The file is removed from the Finalize Indexing list and thedocument status changes to Final.

Indexing a Document in the Doc List1. In the Doc List, locate a document with a status of Index.

2. To view the document content, right-click the document and select View.

3. Right-click the document and select Properties.

4. If you did not select a placeholder before importing the document, do the following:

a. In the Properties, select a scope (level within the TMF structure) and the details required forthe document.

b. In the Name Contains field, start typing the name of the placeholder.

c. In the Placeholder field, select the placeholder for the document.

5. Verify the information in the remaining fields and clickOK. The document status changes to Final.

70


Finding a Document1. Log in as a Contributor.


3. Click Find Documents.

4. In the Choose field, select Find Documents.


6. Click Run.

71


72

Chapter 5Uploading Site-Based Documents forInvestigation

The Investigator workspace enables investigators to import and access documents based on their sites.


• Accessing the Investigator Workspace, page 73

• Viewing the Site Registration Forms, page 73

• Viewing the Missing and Key Documents for a Site, page 74

• Importing Documents to a Placeholder, page 74

Accessing the Investigator Workspace1. Log in as an Investigator.

The Welcome page appears, which lists the number of site that you are assigned to. The page alsolists the number of workflows assigned to you, if any.

2. ClickMy Sites to view information about the product, trial, and your sites.

3. ClickMy Tasks to view the workflow tasks assigned to you.

Viewing the Site Registration FormsThe Investigator workspace lists all the site registration forms for the sites that you are assigned to.

1. On theWelcome page, clickMy Sites.The Site Selection widget lists all the site registration forms for the sites where you are assignedas an investigator. Only forms with the status of Active are listed.

2. Select a site registration form and under Properties, view the properties of the selectedregistration form. Note that you cannot edit the properties of the form.

73

Uploading Site-Based Documents for Investigation

Viewing the Missing and Key Documents fora SiteFor a selected site registration form, theMissing Documents widget lists the placeholders. Theplaceholders are organized based on their status, that is, Required, Recommended, and Optional.When you select a placeholder, the Pending Documents widget lists the documents that are indexedand need to be uploaded.

The Key Documents widget lists the key documents, which includes all product-level, trial-level,country-level, and site-level documents, for that site. External investigators can view only thosedocuments based on the security access provided.

Select a document under Key Documents and click Document Viewer to view the document. TheProperties widget displays the properties of the selected document. Double-click the document todownload it to your system.

Importing Documents to a Placeholder1. UnderMissing Documents, select a placeholder.

2. Drag and drop one or more documents from your computer onto the placeholder. Alternatively,select Import > File from the menu and select the documents to import by navigating yourfile system.


4. Select Same creation profile for all files and click Next. The file automatically inherits therelevant properties of the placeholder. The uploaded document appears in the PendingDocuments area with a status of Index.

74

Chapter 6Create Trial Documents

This section is for Authors, and Trial Managers who create Trial Master File (TMF) documents fromtemplates.


• Controlled Documents, page 75

• File Naming and Versioning, page 78

• Omitting a Placeholder, page 79

• Reinstating a Placeholder, page 80

• Document Updates, page 80

• Configuring Content Templates, page 81

• Importing and Exporting Multiple Documents, page 83

Controlled DocumentsDocumentum eTMF uses placeholders and registration forms to store clinical trial, country, site,and product information. The documents that you create inherit values from the placeholders andregistration forms and automatically populate the Properties of the document. There are severalmethods of inheriting data:• Inherit data from a TMF placeholder: Import or create a document using a TMF placeholder.

• Inherit data from an existing document: Create a document using a similar document.

• Inherit data from a registration form: Import or create multiple different documents related to aparticular site or trial. Search for or Navigate to a related registration form in the Clinical TrialLibrary cabinet and then import or create a document.

The document inherits the initial properties from the selected source. The information from theselected source appears in the Properties of the document after saving it.

To create or import Clinical or Clinical Trial Master File (TMF) documents, users must be members ofthe cd_clinical_doc_authors group.

75

Create Trial Documents

The following table shows the location of TMF placeholders, clinical documents, and clinicalregistration forms in the repository:

Type Repository Location

TMF placeholders Cabinets > Clinical

Clinical documents Cabinets > Clinical

Clinical trial registration forms Cabinets > Clinical Trial Library

This section contains the following topic:• Creating a Document, page 76

• Creating a Clinical Crossover Document, page 77

• Associating a Crossover Document with a Regulatory Application, page 78

Creating a Document1. Log in as a member of the Author group based on the type of document.

2. From the repository, select a related document or registration form.


4. In the Creation profile field, select a functional area, such as Trial Master File (TMF) Document.Your role determines the document creation options that appear.

5. In the Document Type field, select the document to create and click Next.

6. On the Edit properties page, select or type information in the required fields. Typically, authorslet the system populate the unrequired fields.If you select or type data in the non-required fields, the new information overrides the valuesinherited from the registration forms. In some cases, such as keywords, the system merges thedata. The document properties populate from the selected placeholder or registration formwhen you save the document.

7. Click Next. The document appears in its native format.

8. From the application, edit the content as needed.To view the content, refresh the screen. For example, if the native format is Microsoft Word,press Ctrl-A and then F9 to update the content. The EMC Documentum D2 Administration Guideprovides information on configuring Microsoft Office products to show D2 properties.When you are finished, save and close the document.

9. Click Check In and Finish.The system creates the document with a minor version number and file name. The documentis checked in. Based on the document type and Control Category, the document is assigned alifecycle. The system also stores the document in a directory structure based on the required fieldson the Edit Properties page. When you save the document, information from the product and thedomain registration forms appear in the document Properties and the Advanced Properties.

76


Related topics:

• File Naming and Versioning, page 78

• Additional Menu Functions for TMF Documents, page 117

Creating a Clinical Crossover Document

Before creating a clinical crossover document, follow the instructions provided in Creating a FilePlan, page 48 and activate the Clinical Trial Registration Form created for crossover documents. Afteryou have activated the Clinical Trial Registration Form, follow these steps to create the crossoverdocument:

1. Log in as a member of the Author group.

2. From the repository, browse to the Clinical cabinet and in the Doc List, select the templatecrossover document. Alternatively, you can select the Clinical Trial Registration Form that is inthe Active state.


4. In the Creation profile field, select Trial Master File (TMF) Document.

5. In the Document Type field, select the crossover document to create and click Next.

6. On the Edit properties page, select or type information in the fields associated with following tabs:

a. Classification: Provide information about the TMF artifact. If you selected the placeholder,the information gets inherited.

b. Product Info: Provide the product-related information.

c. Regulatory Application Info: If you know the regulatory application to associate with thisdocument, you can select it now or associate it later once you create the document.

d. Process Info: Shows the default users defined in the registration form. Verify the participantsin the workflow and update as needed.

e. Click Next. The document appears in its native format.

7. From the application, edit the content as needed. When you are finished, save and close thedocument.

8. Click Check In and Finish.The system creates the document with a minor version number and file name. The document ischecked in. Based on the document type and Control Category, the document is assigned a lifecycle.The system also stores the document in a directory structure based on the required fields on the EditProperties page. When you save the document, information from the product and the domainregistration forms appear in the document Properties and the Advanced Properties.

In the Locations widget, you can verify that the document is a crossover document by checking forthe Documentum eTMF path and the autolinked Documentum R&D path for the same document.

77


Associating a Crossover Document with a RegulatoryApplication

Use this procedure to associate a crossover document with a regulatory application form defined inthe system.

1. In the Doc List, right-click a crossover document and select Associate Regulatory ApplicationForm.

2. In the Application Forms field, select the registration application form, which represents theRegulatory Application, and click OK.

Related topics:


• Creating a Clinical Trial Registration Form for Crossover Documents, page 35

Creating a Reference Document

If you want to use a product-level document, which belongs to another study or trial, in your trial,you can create a copy of the original document. This is known as a reference document. The contentof the original document is shared with the reference document along with the security settings andfiling location to match those of the study. This enables users to share the reference document insteadof the actual document. Reference documents also help you identify studies that a product-leveldocument should be associated with.

1. Log in as a member of the Author group.

2. Click the Browse button.

3. In the Browser, navigate to the folder where the document you want to create a referenceof resides.

4. In the Doc List, right-click the document and click Assign to Study.

5. In the dialog box, in the Select related studies field, add or remove the studies that you assign thedocument to. The studies that are listed are all that is within the product or references the product.

6. Click OK.The Relations widget displays the newly-created references to the different studies. You cannavigate to the location of the referenced document from this widget. The reference documenthas a status of Reference and a reference is created for all versions of the original document.

File Naming and VersioningThe document name is automatically assigned based on the naming schema: <artifactnumber><artifact name> - <document ID>

78


Where the artifact number and name are up to 230 characters and the document ID is a 9 digitincremental number.

For example, when the artifact number and name is 02.01.02 Protocol and the document ID is000000001, the name displayed in the D2 Client workspace is: 02.01.02 Protocol - 000000001

Note: For artifacts marked as repeating in the file plan, the system appends a sequence number tothe artifact number to track the different instances of the documents. In the previous example, if theProtocol artifact was marked as repeatable, the name of the first instance of the document wouldbe: 02.01.02.01 Protocol - 000000001

When uploading TMF documents, duplicate item numbers are sometimes appended to the artifactnumbers. This is due to the presence of shared (cross-site) documents.

Caution: The system generates the document_id from a 9-digit counter, which allows 100million unique document IDs. In D2-Config, the size of the counter can be increased by editingthe _Document_ID auto naming configuration. However, the document_id attribute in thecd_controlled_doc object type is a ten character string. When the digits are increased above10, the cd_controlled_doc object type must also be changed.

If the counter value on the _Document_ID auto naming configuration is reset after creatingdocuments, subsequent document IDs might not be unique. Consequently, you should not resetthis counter value in a production repository.

Document versions are minor (v 0.1) until they are made Final. Documents in an Final state havemajor version numbers (v 1.0).

The initial version for a placeholder is 0.0. When a placeholder document is checked-out, edited,and checked-in, the next version is checked-in automatically as version 0.1 and is reset to the Draftlifecycle state. The document can then continue to be edited, reviewed, approved, and made Final,according to its Control Category. Placeholders can also be deleted and reverted to the initialplaceholder version 0.0 by a system administrator.

Related topics:


• Additional Menu Functions for TMF Placeholders, page 116

Omitting a PlaceholderTo indicate that a Recommended or Required placeholder is no longer needed, you can mark it asomitted. Users cannot upload documents to a placeholder with a status ofOmitted. The trial progresssummary records the number of omitted placeholders and will no longer report the placeholder onmissing document reports.

1. Right-click a placeholder and select Omit.

2. For Recommended placeholders, in the Change State dialog box, select the reason for theomission and click OK.

79


Related topics:



Reinstating a PlaceholderYou can reinstate an omitted placeholder to its previous state to allow the addition of content forthe placeholder.

1. Right-click an omitted placeholder and select Reinstate.

2. Click Yes to confirm the change.

Document UpdatesThis section contains the following topics:

• Editing a Document, page 80

• Checking in a Document, page 80

• Sharing a Document across Sites, page 81

Editing a Document1. Log in as a member of the Author group based on the type of document.

2. In the Doc List, locate the document.

3. Right-click the document and select Edit. The document is checked out to the user.

4. Update, save, and close the document.

Checking in a Document1. In the Doc List, locate the document.

2. Right-click the document and select Check in.

3. The document is checked in and can be self-approved or added to a workflow.

80


Related topic:

• Launching the Collaborative Editing Workflow, page 94

Sharing a Document across Sites

You can link a site-level document in the TMF to additional site-level folders or unlink them from thefolders, if necessary.

1. In the Doc List, locate a site-level TMF document.

2. Right-click the document and select Share across sites.

3. Select Enable cross-site sharing.

4. In Other Sites, select the sites to share the TMF document.

5. Click OK.Related topic:


Configuring Content TemplatesThe content for a newly-created document is based on a content template. Depending on thedocument that a user creates, Documentum eTMF automatically selects one or more appropriatecontent templates.

A member of the template authors group for a specific domain can create or modify content templatesfor that domain. The artifacts (document types) that a template author assigns to a content templatecontrol the templates that are available to users when documents are created. When a contenttemplate is created the version of 0.1 is assigned with status set to Draft. The template author canthen send the document to the template approvers of the corresponding domain for approval. Onlythe Approved versions of templates are available for selection when users create a new document.

When configuring document templates, review www.Adobe.com for information on the fonts thatappear correctly in PDFs. The fonts used must be available on the client machines and the RenditionServer. The Rendition Server embeds the fonts into the PDF. When Adobe Acrobat cannot find thefonts specified in the content template, it generates a message that warns the user that it is usingalternative fonts in the PDF version. This problem can cause information loss or reformatting issues.Avoid these issues by using fonts that are compatible with Adobe Acrobat.

Topics in this section include:

• Creating a Content Template, page 82

• Modifying a Content Template, page 82

81

http://www.adobe.com


Creating a Content Template1. Log in as a member of the template author group for a particular domain (for example,

cd_clinical_template_author).


3. On the Fill creation profile page:

a. In the Creation profile field, select the management profile or domain. To create a contenttemplate for a Trial Master File (TMF) document, select Clinical Trial Management for eTMF.

b. In theDocument Type field, select the content template type. To create a content template fora TMF document, select Clinical Content Templates.

c. Click Next.

4. On the Edit properties page:

a. Type a name for the template in the Name field.

b. In the Applicable Artifacts area, select artifacts (document types) to use for the templatefrom the List Assistance dialog box, and click OK.This template will be available for selection when documents with listed artifacts are created.

c. Click Next. The content template appears in the Templates/D2 folder.

5. Select your content template and then select Import > New version from the menu bar.

6. In the Import dialog box, select a template file to import and click OK.

7. In the Checkin dialog box, select a version for the template and click OK.

Modifying a Content Template

You can modify a content template and the artifacts associated with the template. The artifacts thatyou assign to the content template control the templates that appear to users when they create adocument.

1. Log in as a member of template author group for a particular domain (for example,cd_clinical_template_author).

2. In the Browser, navigate to the Templates/D2 folder.

3. Right-click the content template and select Edit to adjust the template in its native format.

4. Exit, save, and check in the template.

5. To adjust the applicable artifacts, right-click the content template and select Properties.

6. In the Properties dialog box, adjust the selected applicable artifacts.Include an artifact (document type) if you want this content template available for users creatingthat document type. Remove an artifact if you do not want this content template available tousers creating that document type. For example, if you remove the Analysis Datasets artifact,this content template no longer appears to authors who create this type of document.

7. Click OK to update the content template properties.

82


Importing and Exporting Multiple DocumentsDocumentum eTMF uses document packages to import and export Trial Master File (TMF)placeholders, documents, and associated document information (metadata). Clinical Trial Managerscreate a document package in the repository and zip the package to export it to the local file system.The ZIP file contains a Contents folder that contains documents and an Index.xls Microsoft Excelspreadsheet that contains metadata. Trial managers can electronically send the package to a recipientwho can work on the documents and metadata on their own computer, without connecting to theTMF system.

The recipient can unzip the document package, view the document package contents, and openthe Index.xls spreadsheet. The recipient can use the spreadsheet to add documents from their filesystem or to modify the content files in the package. They can also update the metadata in theMicrosoft Excel spreadsheet.

The Index.xls file, also known as the bulk import-export spreadsheet, is not the same as a TMF fileplan spreadsheet. The following figure shows an example bulk import-export spreadsheet:

Users populate the File List worksheet with information about the documents they want to import.The File List worksheet contains the metadata for each document. It contains references to either thecontents of the document package or to local file names if they are adding files to the package.

The Schema worksheet defines the form and content of the spreadsheet. This information ispreconfigured for system use. The values in the drop-down lists on the File List worksheet comefrom the schema.

Note: An Alias column has been added to the Schema worksheet to enable dictionary aliases tobe specified. For example, you can add a "Synonym" alias to the "TMF Unique Artifact Names"dictionary and override the default artifact display names in this column. If a dictionary alias is notspecified or blank, the locale setting is used for dictionary lookups. The default locale is "en" (English)although this can also be specified in the schema settings.

After updating the document package, the recipient zips the modified document package for importinto the repository. The document package, also known as the TMF bulk import-export package,imports into the repository as a new version of the package. When importing multiple documentsusing the bulk import-export spreadsheet, the system only imports and updates changed files.

83


Complete the following procedures to create document packages, export them to the local file systemfor modifications, and then import them back into the repository:

• Creating a TMF Bulk Import-Export Package for a Trial, page 84

• Zip and Export the TMF Bulk Import-Export Package, page 85

• Populating the Bulk Import-Export Spreadsheet, page 88

• Importing the Document Package ZIP File, page 89

• Starting the Bulk Import of Documents, page 89

Creating a TMF Bulk Import-Export Package for a Trial1. Log in as a member of the cd_clinical_trial_managers group.

2. In the Clinical Trial Library cabinet of the Browser, select a clinical trial registration form andthen select New > Content from the menu bar.


4. In the Document Type field, select Bulk Import / Export Package and click Next.

5. Configure the TMF bulk import-export package properties as described in the following table:

Field Description

Package Name Type the name of the bulk import-export task.

Description Type a description of the TMF bulk import-export package.

Product Name Select the product name (for example, compound name)associated with the clinical trial.

Clinical Trial ID Select the unique ID for the clinical trial.

Study Phase Shows the study phase for the selected clinical trial.

Study Name Shows the study name for the selected clinical trial.

The Product Name and Clinical Trial ID automatically populate as defined in the registrationform.

6. Click Next. The system files the bulk import-export spreadsheet in the Document Packagessubfolder below the clinical trial registration form and sets the status to New.

7. Zip and export the TMF bulk import-export package for offline review and updates. Zip andExport the TMF Bulk Import-Export Package, page 85 provides more information.The ZIP operation automatically refreshes the value assistance for the bulk import-exportspreadsheet. To update and view the value assistance before zipping the package, you can refreshthe spreadsheet. Refreshing the Value Assistance for the Bulk Import-Export Spreadsheet, page85 provides more information.

84


Refreshing the Value Assistance for the BulkImport-Export Spreadsheet

The bulk import-export spreadsheet contains a Schema worksheet that controls many of the fieldsand labels on the File List worksheet. Some of the fields on the Schema worksheet populate basedon characteristics of the trial. For example, the registered countries and sites for a trial populate theSchema worksheet so that a user can select these values on the File List worksheet. If you register anew site with the trial, refresh the value assistance for the Schema worksheet to add the new values.

1. In the Browser, navigate to your bulk import-export spreadsheet.

2. Right-click the spreadsheet and select Refresh.

3. Click Yes to confirm the drop-down list updates.

Zip and Export the TMF Bulk Import-Export Package

After creating a document package, you can specify the documents and placeholders to include in thepackage. The system creates a ZIP file that contains metadata and any content files for the selecteddocuments and placeholders.

1. In theDocument Packages folder, right-click the TMF bulk import-export package and select Zip.

2. Configure the TMF bulk import-export package contents as described in the following table:

Field Description

Include in the package Select whether to include placeholders, documents, or bothin the package.

File Format Select whether to include PDF renditions, native contentfiles, or both in the package.

Scope Select whether to include all documents (artifacts); productand trial-level documents; country and site documents for aspecific country; or site-specific documents.

Sites If you select site-specific documents, select the sites toinclude in the package.

Countries If you select country and site documents, select thecountries to include in the package.

From Date

To Date

To filter the documents in the package by creation date,select a date range. Leave the date fields blank if you do notwant to filter by creation date.

To select documents created since a particular date, select aFrom Date but not a To Date.

If you click a date field and press Delete to clear it, press theTab key to refresh the Number of items field.

85


Field Description

Number of items Shows the number of items in the package. If the numberof items is 0, you cannot create a package.

Allow other document types tobe added

Enables users to include other reference model documenttypes in the package. Clear this option to restrict thedocument types to those document types defined in thepackage.

3. ClickOK. The TMF bulk import-export package status changes to Zipped. To refresh the packagestatus, click the Document Packages folder in the repository.

4. To check the status of the zipped package, right-click the package and select Properties. Thepackage properties show the results of the last operation.

86


If necessary, you can rezip an invalid package by selecting it and repeating this procedure usingdifferent selection criteria. You do not have to create another package.

5. To export the zipped TMF bulk import-export package:

a. Select the zipped package and select Content > Export from the menu bar.

b. Select a folder on the local file system to export the zipped package.

6. Unzip the contents of the zipped TMF bulk import-export package to a clean folder on the localfile system. The Documentum metadata file extracts into a Microsoft Excel spreadsheet namedIndex.xls. The content files and PDF renditions extract into the Contents subfolder. If yourpackage includes only placeholders, the zip file only contains the Index.xls file.

7. Edit the Index.xls file (bulk import-export spreadsheet) to add and modify content files andupdate associated metadata. If necessary, you can attach the zipped package to an email andsend it to another user.

Related topic:

• Populating the Bulk Import-Export Spreadsheet, page 88

87


Populating the Bulk Import-Export Spreadsheet1. In the Microsoft Excel bulk import-export spreadsheet, click the Enable Content button to enable

the macros.

2. On the File Listworksheet, specify the documents and metadata to add or modify as described inthe following table:

Column Description

Filename To select a content file, double-click an empty cell in theFilename column. The system automatically copies the fileto the Contents subfolder and points to that file. If there isa file with the same name in the Contents subfolder, thesystem renames the file with a unique name.

This field is blank for placeholders until you add content.

To edit an included file, click a hyperlink to open the fileand then modify and save the file. After importing andunzipping the file, the system detects the changes in the file.

Artifact Name Select the document type.

Item number Use this column to import multiple documents forrepeatable artifacts. Repeatable artifacts can have morethan one document. You can insert multiple rows into thespreadsheet and number the documents in sequence from 1.

If you leave this column blank or set it to 0 (zero) andthe artifact is repeatable, the system creates a documentand assigns the next item number in sequence to itautomatically. If the artifact is not repeatable, it creates anew version of the document if a document exists.

Scope Select the location of the document in the Trial Master File.

Country (where applicable) For country-level documents, select the country. Thisfield is optional for site-level documents. For product ortrial-level documents, leave this field blank.

Site (where applicable) For site-specific documents, select the site; otherwise, leavethis field blank.

Document Title Type the document name.

Keywords Type keywords for the document. Type multiple values asa comma-separated value list such as 1,2,3.

Status Type the lifecycle state of the imported document. Forexample, you can type Final to import the document asFinal versions.

If you leave this field blank, the Unzip operation uploadsthe new content files as Draft documents by default.

Hover your cursor over the column heading cells to view additional information.

88


3. To help identify the documents or placeholders, you can view the read-only fields highlighted inlight blue. The read-only fields include Version, Validity, and the Repository Path of the importedor exported item. The Validity column shows any validation errors.

4. Do not update the Schema worksheet. The system automatically updates the schema. Theinformation in the drop-down lists on the File List worksheet comes from the schema.


6. If the bulk import-export package is on your local file system:

a. Delete the original ZIP file package.

b. Recreate the ZIP file package using the following structure:• <package_name>.zip

— Index.xls (This file is the updated bulk import-export spreadsheet)

— Contents (This subfolder contains all of the content files for import or export.)

— artifact.doc

— artifact2.pdf

c. Import the TMF bulk import-export package ZIP file. Importing the Document Package ZIPFile, page 89 provides more information.

Importing the Document Package ZIP File

After zipping a document package, you can import an updated version of that package into thesystem to update the objects in the package. For example, you can create a document package ZIP filefor a specific site that contains all of the placeholders. You can send the ZIP file to the site monitorwho can update the bulk import-export spreadsheet and add documents to the placeholders. The sitemonitor can then send you an updated ZIP file to import into the system.


2. In the Document Packages folder, select the zipped TMF bulk import-export package to update.

3. Select Import > New Version from the menu bar.

4. Select the TMF bulk import-export ZIP file on your local file system and click OK. The status stillshows as Zipped since it contains a ZIP file.

5. Click the Versions tab to verify the new document package version.

6. Process the TMF bulk import-export ZIP file in the repository. Starting the Bulk Import ofDocuments, page 89 provides more information.

Starting the Bulk Import of Documents

After you import an updated ZIP file into the document package, the system processes it when a trialmanager or other user with the appropriate permissions performs an unzip operation. The Unzipuses the information in the bulk-import spreadsheet to update the object metadata and content.

89


1. In the Browser, right-click the TMF bulk import-export ZIP file and select Unzip.

2. Specify how to extract the TMF bulk import-export package ZIP file contents as described inthe following table:

Field Description

Extract Select whether to extract all documents (artifacts); productand trial-level documents; country-specific documents; orsite-specific documents.

Including unplanned content Select whether to enable the import of unplanneddocuments. Unplanned documents do not havecorresponding placeholders in the repository.

Select this option to import unplanned content and createTMF documents in the repository.

Clear this option to import only planned content in therepository.

3. Click OK. The status changes from Unzipping to Unzipped.If the import is successful, the contents of the TMF bulk import-export package ZIP file importinto the repository in the location specified by the bulk import-export spreadsheet. The statusof the package changes to Unzipped. Right-click the package and select Properties to view thepackage status. You can also open the unzipped bulk import-export spreadsheet and check theValidity column to verify that the affected rows processed correctly.If the import is unsuccessful, the status changes to Invalid. If the package status is invalid,right-click the package and select Properties to view the error message. Manually correct thepackage, check it in as a new version, and reprocess the package.

4. Navigate to the Clinical cabinet to view the files created from the ZIP file.

90

Chapter 7Review and Approve Trial Documents

This section is for Authors, Document Coordinators, Reviewers, Approvers, and Trial Managers whoparticipate in the review and approval of Trial Master File (TMF) documents.


• Workflow Process, page 91

• Document Review and Approval, page 94

• Performing Tasks in a Workflow, page 95

• Processing Documents in a Workflow, page 98

• Working with Final Documents, page 103

• Viewing Document Status, page 106

• Viewing Workflow Progress, page 107

• Workflow Task Performer Changes, page 108

Workflow ProcessA workflow is a series of tasks that users perform on documents. Tasks appear in their inboxes withdocuments and instructions on how to complete the tasks. For example, an author starts a workflowby sending a document to one or more reviewers using a review workflow. When the workflowstarts, the system automatically sends the document to all the specified reviewers to perform a reviewtask. Each reviewer receives a review task. When all the reviewers finish their tasks, the workflowends. The workflow creates separate tasks for each user participating in the workflow.

There are two main types of workflow users:

• Workflow task performers: These users complete tasks in a workflow.

• Workflow supervisors: These users initiate the workflow. Workflow supervisors are usuallyAuthors or Document Coordinators. Authors can act as document coordinators on Trial MasterFile (TMF) documents.

The Life Sciences solution provides four category levels to secure documents as the documentsprogress through the tasks of a workflow. The solution assigns the control categories internallybased on the document type. These control categories are invisible to end users. The document typedetermines the workflows that can be applied to the document within a particular control category.

91

Review and Approve Trial Documents

Documentum eTMF uses the following workflows for TMF documents:

Workflow Description

Collaborative Editing Sends a document to a group of Reviewers for initial feedbackor collaborative authoring. The Reviewers coauthor thedocument and edit the document at the same time. Authorscan incorporate the changes into the document and makeadditional revisions.

Submit for Review and Approval(Category 2)

Sends a document for review and approval.

A Reviewer can review the document by accepting the taskor reject it by annotating the document and sending it backto the Author for correction. If a document has annotations,the system auto-rejects the document and sends it back to theAuthor in the Draft state. If the Reviewer accepts the task, thedocument goes to the Approvers. The Approver can approvethe document or send it back to the Author.

If the Approver rejects a reviewed document, the documentreturns to the Author in the Draft state. After the Authoraccepts the task and makes the required changes to thedocument, the Author can skip the review task and send thedocument directly to the Approver for approval.

Approvers might have to electronically sign off on thedocument depending on its type. An Author cannot be anApprover on the same document.

Submit for Review-FormatApproval (Category 2)

Sends a document for review, format review, and approval.

A Reviewer can review the document by accepting the taskor reject it by annotating the document and sending it backto the Author for correction. After the Author makes thenecessary changes, the document is sent to the Reviewer again.If a document has annotations, the system auto-rejects thedocument and sends it back to the Author in the Draft state.

If the Reviewer accepts the task, the document goes to theFormat Reviewer. The Format Reviewer reviews the documentand can either accept the task and move the document forwardor can reject the task, annotate the document, and send it backto the Author. If a document has annotations, the systemauto-rejects the document and sends it back to the Author inthe Draft state. The Author can make changes to the revieweddocument and send it to the Reviewer or Format Reviewer foranother review. The Author can also skip the review roundand send the document directly to the Approver.

If the Format Reviewer accepts the task, the document goesto the Approver. The Approver can approve the documentor send it back to the Author.

92


Workflow Description

If the Approver rejects a document, the document returns tothe Author in the Draft state. After the Author accepts the taskand make the required changes to the document, the Authorcan skip the review tasks and send the document directly tothe Approver for approval.

Approvers might have to electronically sign off on thedocument depending on its type. An Author cannot be anApprover on the same document.

Submit directly for Approval(Category 2)

Sends a document for approval without a review. An Authorcannot be an Approver on the same document.

Submit for Review (Category 3) Sends a document for review. If you select multiple Reviewers,the workflow sends the documents to all of them at the sametime.

A Reviewer can review the document by accepting the taskor annotate the document and send it back to the Author.If a document has annotations, the system auto-rejects thedocument and sends it back to the Author in the Draft state.

The Author receives a task to either finalize the document orto revise it and send it back to the Reviewer.

Submit for Delegated Approval(Category 3)

Sends a document to a delegated Approver for approvalwithout a review. Reviewers are the delegated Approvers forthe document.

Content Template Approval Sends a content template for approval.

After creating the content template, the template Author sendsthe document to the template Approver for approval.

The template Approver can approve the document or sendit back to the Author. If the Approver rejects a document,the document returns to the Author in the Draft state. TheApprover must electronically sign off on the document onapproval.

Authors generally use these workflows one after the other. Authors initially send documents forcollaborative editing. After incorporating the changes in the document, they can send the documentto other Reviewers before they finalize it.

The following figure illustrates the typical order of the Documentum eTMF workflows:

93


In addition to using workflows that involve other Reviewers, Authors can self-approve and finalizeTMF documents directly by changing the lifecycle state of the document to Final.

Document Review and ApprovalThis section contains the following topics:

• Launching the Collaborative Editing Workflow, page 94

• Launching the Review Workflow, page 95

• Self-approving a Document, page 95

Launching the Collaborative Editing Workflow1. Log in as a member of an Author or Document Coordinator group.

2. Right-click a document and select Submit for Collaborative Editing.

Note: The document type determines the workflows that can be applied to the document.

3. In the Planning / Sending of Workflow dialog box:

a. On the Recipients tab, verify the participant group fields. Modify the recipients as needed.

b. ClickNotifications to type information about the document. The participants of the workflowreview theWorkflow notes as the document completes task processing.

c. Click Attachments to add additional content required for processing workflow tasks.

d. Click Planning and Follow-up to select a date for planning and following up on the task inthe workflow.

4. Click Send to send the document to the specified user in the workflow.

94


Related topics:

• Collaborative Editing, page 98

Launching the Review Workflow1. Log in as a member of an Author or Document Coordinator group.

2. Right-click a document and select Submit for Review / Approval.

Note: The document type determines the workflows that can be applied to the document.

3. In the Planning / Sending of Workflow dialog box:

a. On the Recipients tab, fill in the participant group fields.

b. ClickNotifications to type information about the document. The participants of the workflowreview theWorkflow notes as the document completes task processing.

c. Click Attachments to add additional content required for processing workflow tasks. Youcan add multiple documents to the same workflow in theWorkflow documents field.

d. Click Planning and Follow-up to select a date for planning and following up on the task inthe workflow.

4. Click Send to send the document to the specified participant in the workflow.Related topics:

• Reviewing Documents in a Review Task, page 100

• Reviewing Document Feedback from Reviewers, page 101

• Approving Documents, page 102

Self-approving a Document1. In the Doc List, right-click a document and select Self-approve and make

“Effective/Approved/Final”.

2. Fill in the fields, if required, and click OK.

Performing Tasks in a WorkflowAs documents progress in an Documentum eTMF workflow, users are assigned tasks based on theirrole. For example, Reviewers perform reviewing tasks and Approvers perform approving tasks.Documentum eTMF provides defined groups for each role.

In the workflows for controlled documents, task participants have five days to perform a task. Taskparticipants receive messages in their Tasks inbox to remind them that a task requires attention.Messages are sent when a workflow task participant does not perform the task in three days, amessage notifies the task participant that they have two days to complete the task. Tasks that are not

95


complete within two days are rejected. A message is also sent to the workflow initiator (usually theAuthor) that the task is not complete.

The following actions are standard workflow actions for processing tasks:• Acquire Task: Confirms that the task has been read and received.

• Accept Task: Confirms that the task has been completed and its quality accepted. Depending onthe type of workflow that is run, this label might vary.

• Reject Task: Confirms that the task is completed or its quality was not acceptable. Depending onthe type of workflow that is run, this label might vary.

• Abort workflow: Closes the workflow. Administrators and workflow supervisors can performthis task.

The following table lists the respective default labels for accepting and rejecting a task in eachworkflow.

Workflow and Step Accept Task Label (PositiveResponse)

Reject Task Label (NegativeResponse)

Collaborative Editing

Step 1: Coauthor/Review Edits Complete NA

Step 2: Primary Author Changes Consolidated NA

Submit for Review and Approval (Category 2)

Step 1: Review Reviewed Without Comments Reviewed With Comments

Step 2: Approval Approve Reject

Submit directly for Approval (Category 2)

Step 1: Approve Approve Reject

Submit for Review-Format Approval (Category 2)

Step 1: Review Reviewed Without Comments Reviewed With Comments

Step 2: Formatting Formatting Complete NA


Submit for Review (Category 3)

Step 1: Review Reviewed Without Comments Reviewed with Comments

Submit for Approval (Category 3)


The EMC Documentum D2 User Guide provides additional information on performing standardDocumentum D2 tasks in a workflow.

Related topics:

• Viewing the Audit Trail, page 97

• Categorizing Inbox Tasks, page 97

96


Viewing the Audit Trail

Documentum eTMF audits events for controlled documents. The system does not audit events fornon-controlled documents.

1. Click Tasks to open the tasks view.

2. To view the audit trail for a task, navigate to theWorkflow Task List, select a task, and thenclick the Audit tab.

3. To view the audit trail for a document, select a document and click the Audit tab.

4. To export the report information in a portable format, right-click the Audit tab and select Exportto Excel.

Categorizing Inbox Tasks1. Click Tasks.

2. Click the down arrow on theWorkflow Task List tab and select Switch widget.

3. Select the Tasks browser widget. The tasks in the inbox appear in different categories.

4. In another area, add theWorkflow Task List widget. For example, click the + tab (Add widget)next to the Task Attachment tab and select theWorkflow Task List widget.

97


5. In the Tasks browser, click a category to view the tasks in theWorkflow tasks list tab.

Processing Documents in a WorkflowThe following topics describe how to process documents in a workflow:

• Collaborative Editing, page 98

• Editing a Document in a Workflow, page 98

• Consolidating Document Changes, page 99

• Reviewing Documents in a Review Task, page 100


• Approving Documents, page 102

• Reviewing Document Feedback from Approvers, page 102

Collaborative Editing

In the Collaborative Editing workflow, Authors and Reviewers edit documents in the Editing:<document_name> task. The Author originating the workflow incorporates the changes into thedocument from the Reviewer feedback. When the Collaborative Editing workflow finishes, you cansend the document to the Review workflow.

Follow these procedures to edit documents:

• Editing a Document in a Workflow, page 98

• Consolidating Document Changes, page 99

Editing a Document in a Workflow1. Depending on the workflow, log in as a member of an Author or Reviewer group.

98


2. In theWorkflow Task List, select the task.

3. In Task Attachment, select the document and then select Content > Review and Edit PersonalCopy from the menu bar. If the document contains annotations from others Reviewers, selectContent > Review and Edit Consolidated Copy. You can verify if the document has annotationsin the Relations tab.

Note: D2 supports adding and editing annotations only in the Microsoft Word native format. Theannotations functionality does not work for other formats such as Excel, PowerPoint, and so on.See the EMC Documentum D2 User Guide for more information about annotations.

In Collaborative Editing workflow, when a document is opened in the Word 2013 native formatduring the Review phase, a Reviewer can disable the Track Changes feature in Word and modifythe original content in the document. However, this negates the purpose of the collaborativeediting as the other Reviewers in the workflow will not know if any changes were made to thedocument. As there is no option to lock the disabling of Track Changes in Word 2013, you mustnot disable Track Changes for documents opened in Word 2013 in the Collaborative Editingworkflow.

4. Edit the document in its native format and save the changes.

5. Click Relations, right-click the document with annotations, and select Check in.

6. In theWorkflow Task List, right-click the task, select Edits Complete, add a comment, andclick OK.When the task is rejected, the document is routed to the Author (workflow initiator) in theEditing task.

Consolidating Document Changes1. Log in as a member of an Author group.

2. Click the Tasks button to open the tasks view.


4. In Task Attachment, select the document and then select Content > Checkout and MergeChanges from the menu bar.

5. Edit the document in its native format, accept or reject the changes, and save the document.

6. Right-click the document, and select Check in.

7. Right-click the task and select Changes Consolidated.

8. In the Task dialog box, add comments and select one of the options:• Select End Workflow to stop the workflow.

• Select Return the document to the Reviewers to continue editing the document.

9. Click OK.

10. If the document can be self-approved, right-click the document, select Self-approve and make“Effective/Approved/Final”, and click OK. If this option is not available, the document mustbe formally-reviewed and approved before it becomes Final.

99


Reviewing Documents in a Review Task

In the Review tasks of the TMF document review workflow, Reviewers review documents.

The Author, who originates the workflow, reviews the feedback received from the Reviewers in aseparate workflow task.

1. Log in as a member of a Reviewer group.



4. Select the document from the Task Attachment area.

5. To review and annotate the PDF document format:

a. In the Task Attachment area, double-click the document and annotate the PDF.

b. When you finish reviewing the document, save and close it.

c. To check in the annotations, click Relations, right-click the document with annotations,and select Check in.

6. To annotate the document in its native format, for example, in Microsoft Word:

a. In the Task Attachment area, select the document and then select Content > Review andEdit Personal Copy from the menu bar. If the document contains annotations from othersReviewers, select Content > Review and Edit Consolidated Copy. You can verify if thedocument has annotations in the Relations tab.

b. Edit the document in its native format and save the changes.

c. To check in the annotations, click Relations, right-click the document with annotations,and select Check in.

7. For Control Category 2 documents, after reviewing the document, in theWorkflow Task List,right-click the task and select Reviewed Without Comments or Reviewed With Comments todemote the document to Draft and send a task to the Author for additional changes.

8. For Control Category 3 documents, after reviewing the document, in theWorkflow Task List,right-click the task and select one of the following options:• Reviewed Without Comments: This option assigns Reviewed status to the document andmakes it ready to be promoted to Approved.

• Reviewed With Comments: This option rejects the document and returns it to the Author inthe Draft state.

100


Related topic:


Reviewing Document Feedback from Reviewers

When the Reviewers return a document to the Author (workflow originator) for further changes, theAuthor receives a task to review the document. The document reverts to the Draft state. The Authorreviews and merges the comments and annotations from the Reviewers.

1. Log in as a member of an Author group.



4. In the Task Attachment area, double-click the document to view any PDF annotations.

101


5. To merge native annotations from the Reviewers (for example, tracked changes in MicrosoftWord):

a. In the Task Attachment area, select the document and then select Content > Checkout andMerge Changes from the menu bar.

b. Merge comments by accepting or refusing the modifications.

c. Save and close the document.

d. Right-click the document and select Check in.

6. For Control Category 2, right-click the task and select one of the following options to completethe task:• Select Resend to route the document back to the Reviewer, to the Formatter Reviewer, or skipthe review phase and send the document directly for approval.

• Select End Workflow to end the workflow.

7. For Control Category 3, right-click the task and select one of the following options to completethe task:• Select Resend to route the document back to the Reviewer.

• Select End Workflow to end the workflow.

Approving Documents1. Log in as a member of an Author for the TMF document Review workflow.



4. To review the document, in the Task Attachment area, double-click the document to view itin PDF format.

5. When you finish reviewing the document, right-click the task and select one of the followingoptions:• Select Approve to approve the document and prepare to make the document approved. Theworkflow completes and the document state changes to Approved.

If you accept the task, in the Sign off dialog box, type your login credentials and select areason to electronically sign the document and click OK. The system records your intentionin the audit trail of the document.

Note: The document type determines whether an electronic signature is required for approval.

• Select Reject to demote the document and return it to the Author in the Draft state.

Reviewing Document Feedback from Approvers1. Log in as a member of an Author group.


102



4. In the Task Attachment area, double-click the document to view any PDF annotations.

5. In the Task notes, double-click the note from the Approver.

6. In theWorkflow Note dialog box, review the comments from the Approver and then click Close.

7. To make changes to the document, in the Task Attachment area, select the document and thenselect Content > Checkout and Merge Changes from the menu bar.

8. Edit the document in its native format and save the document.

9. Right-click the document, and select Check in.

10. Right-click the task and select one of the following options to complete the task:• Select Resend to route the document back to the Approver or Reviewer.

— Select Promote to For Review to send the document to Reviewers.

— Select Promote to For Approval to skip the review task and send the document directlyfor approval.

— Select Promote to For Formatter Review to skip the review task and send the documentfor format review. This option appears only in the Submit for Review Format Approvalworkflow.

• Select End Workflow to complete the workflow and retain the document in the Draft state.

Working with Final DocumentsThis section contains the following topics:

• Suspending a Document, page 103

• Withdrawing a Document, page 104

• Deleting Documents Permanently, page 104

• Superseded Documents, page 105

• Expiry Review of Documents, page 105

• Updating the Expiry Review Date for a Document, page 106

Suspending a Document

Suspending an Final document prevents it from being used while a modified version is beingprepared, reviewed, and approved. You must be a Coordinator to perform this task.

1. In the Doc List, right-click a document in the Approved state and select Suspend document.

2. Click OK.

3. To reinstate the document, select Reinstate as “Effective/Approved/Final” version.

103


4. In theMake document Effective/Approved/Final dialog box, click OK.

Withdrawing a Document

You can retire documents in the Draft, Release Pending, or Final states by withdrawing them. Allversions are withdrawn together. You can retain Withdrawn documents as historical records.

Document Coordinators or any user with sufficient access rights can permanently remove Withdrawndocuments from the system using Hard Delete.

1. In the Doc List, right-click a document and selectWithdraw document.

2. In theWithdrawal Reason field, type the reason.

3. Click OK.

4. To reinstate a withdrawn document, select Revert to Draft.

Deleting Documents Permanently

Clinical Document Coordinators or any user with sufficient access rights can permanently deletedocuments from the system using Hard Delete. When users perform a Hard Delete of a document,Documentum eTMF audits the event. You can search for these events in the audit trail. For example,Clinical Document Coordinators can use this feature to delete trial documents permanently at the endof the trial retention period.

Caution: It is not possible to recover hard deleted documents.

1. In the Doc List, select one or more documents in the Withdrawn state. If you have aWithdrawntab, you can select the tab and then select one or more documents from within the tab.

2. Right-click the documents and select Hard Delete.

3. Type or select a reason for removing the documents permanently and click OK. The systemdeletes only the selected version of the document. Documentum eTMF audits the hard deleteaction for each document deleted under the event name cdf_hard_delete. If you select multipledocuments, the system applies the same reason to the audit event for each document.If the administrator configures the system to delete related documents, the system deletes bothdocuments. The system records only the dm_destroy event (not the cdf_hard_delete event)for the related document.You can view hard deleted documents using the Find Delete Audit Events search query.

104


Related topic:• Chapter 9, Find Documents

Superseded Documents

Superseded documents are documents that were previously Approved. There is only one Finalversion of a document at a time. The system automatically updates the document state when newFinal versions are created. For example:1. Version 0.1: Process a document in a Submit for Review and Approval workflow.

2. Version 1.0: Approvers change the document state to Final. The version is 1.0.

3. Version 1.1: The document is edited by the Author and in a Draft state.

4. Version 1.1: Process a document in a Submit for Review and Approval workflow.

5. Version 2.0: Approvers change the document state to Final. The updated Final document isversion 2.0. The original document, which was version 1.0, is now automatically changedto Superseded.

Users cannot suspend, withdraw, or change the version of a superseded document. They onlyhave READ permission on the superseded document. They cannot check out or edit a supersededdocument (all non-current versions of a document).

Expiry Review of Documents

Control Category 2 documents in the Final state must go through the Expiry Review workflow beforethey can be expired. Follow these steps to perform the expiry review task:

1. Log in as a member of the Document Coordinator, Clinical Trial Manager, or Product Managergroup participating in the expiry review workflow.


3. In theWorkflow Task List, right-click the task and click Accept task.

4. On the Task tab, select one of the following options:• Withdraw document: Changes the state of the document to Withdrawn.

• Allow to Expire: Changes the state of the document to Expired.

• Revision is required (author(s) must be assigned): Returns the document to the author(s) inthe Draft state for revision.

5. On theWorkflow participant(s) tab, in the Review Acknowledge (authors) list, provide the listof authors who must acknowledge that a revision on the document is required.

6. Click OK.

105


Updating the Expiry Review Date for a Document

Control Category 2 documents that are about to be expired must go through a review process.This expiry review process is automatically triggered on a predefined review date. DocumentCoordinators can modify the expiry review date using the following steps:

1. Log in as the member of the Document Coordinator group.

2. In the Doc List, right-click a Category 2 document that has a status of Approved and then clickAdjust Expiration Dates.

3. In the Set Expiry Review Dates dialog box, in the Next Expiry Review Date field, specify a datefor when the expiry review workflow is to be triggered.

4. In the Expiry Review Recipients field, add or remove the user or group that receives the reviewtask. Typically, the recipients include Document Coordinators or Managers.

5. Click OK.When the expiry review date triggers, the assigned Document Coordinators or Managers receive asystem notification to initiate the expiry review process for the document.

Viewing Document StatusUsers can view the progress of a document in the document properties.

1. In the Doc List, locate the document.

2. Right-click the document and select Properties.

3. On the Process Info tab, you can view the control category of the document and its status.

106


4. Click Cancel.

Viewing Workflow ProgressAuthors and Document Coordinators can monitor the progress of document workflow tasks.

1. Log in as a member of a Document Coordinator or Author group.

2. Select a document in the Doc List and clickWorkflow overview.

3. Expand the workflow to view the workflow tasks. Active workflows and tasks show a Runningstate.

107


Workflow Task Performer ChangesAfter a workflow starts, it is often necessary to change the performer of a workflow task. For example,a reviewer may not be available to complete a review inbox task. In this case, the reviewer candelegate the task to another workflow task performer.

Workflow task performers can delegate the tasks in their inboxes to other workflow task performers.

Workflow supervisors can change the workflow task performers in the following ways:

• Delegate a task that is in the inbox of any workflow task performer. For example, a workflowsupervisor can delegate a task because an employee left the company or is out of the office onsick leave. You can delegate only the tasks that are in the inbox of workflow task performers,not future tasks.

• Stop a workflow and send a document to a new workflow to add additional performers to acurrent task. For example, a workflow supervisor sends a document to the Review workflow andthe workflow creates a task for Reviewer 1. The workflow supervisor can stop the workflow andthen resend the document for review to Reviewers 1, 2, and 3.

There are two sets of performers for a document. One set is the performers defined on the ProcessInfo tab of the document properties. The other set is the performers that actually participate in theworkflow. When a workflow starts, the workflow task performers are set based on the performerslisted on the Process Info tab. Any change in the workflow performers using the Update performers,Send to workflow, or Reassign Roles menu options changes only the actual workflow performers. Itdoes not change the performers shown on the Process Info tab. These workflow performers haveaccess to the documents only when they are the current performers, that is, they have a task intheir inbox.

Updating Workflow Task Performers1. Log in as a workflow supervisor.

Note: The workflow initiator and Coordinators can update the workflow performers for active(acquired or not) and future tasks.

2. Navigate to the document for which you are updating performers.

3. In the Doc List, select the document and clickWorkflow overview.If you do not have aWorkflow overview tab, click the + tab and select theWorkflow overviewwidget.

4. In theWorkflow overview, right-click a workflow with a state of Running and select Updateperformers.

108


5. Update the performers as needed and click OK.You can only update performers for tasks that are not active. For example, if a document is ona review/approval workflow and is in For Review phase, you cannot change the Reviewersbut you can change the Approvers.

Stopping a Workflow1. Log in as a workflow supervisor.

2. Navigate to the document for which you want to stop the workflow.

3. In the Doc List, select the document and clickWorkflow overview.

4. In theWorkflow overview, right-click the workflow you want to stop and select Abort workflow.

5. Click OK. The workflow state changes from Running to Aborted.

Delegating a Task as a Workflow Supervisor1. Log in as a workflow supervisor.

2. Navigate to the document for which you are delegating a task.

3. In the Doc List, select the document and clickWorkflow overview.If you do not have aWorkflow overview tab, click the + tab and select theWorkflow overviewwidget.

4. In theWorkflow overview, expand the workflow, right-click the user whose task you want todelegate, and select Delegate task.

109


5. In the From the user field, select the user whose task you want to delegate.

6. In the To the user field, select the user to receive the task and click OK.

Delegating a Task as a User

All workflow users can delegate their tasks to another workflow performer.

1. In theWorkflow Task List, locate a task to delegate.

2. Right-click the task and select Delegate task.

3. In the User field, select the user to receive the task and click OK.

Reassigning Roles1. Log in as a member of a Document Coordinator or Author group. Authors and document

coordinators can reassign roles for TMF documents.

2. Right-click a document and select Reassign Roles. Change the user groups assigned to the rolesas needed. Each tab represents a different user role. For example, on the Approvers tab, youcan replace the approvers listed for that role.

3. Click OK.

110

Chapter 8Inspect a Trial

This section is for Inspectors and internal Clinical Auditors, who audit clinical trials.


• Locating Documents, page 111

• Finding Documents using Facets, page 112

• Viewing Documents and their Properties, page 112

• Viewing Documents Side-by-side, page 112

• Adding Notes, page 113

• Viewing and Deleting Notes, page 113

• Viewing the Document History, page 113

• Deleting and Restoring a Document, page 113

• Export the Doc List to Microsoft Excel, page 114

• Additional Menu Functions, page 114

Locating DocumentsThe eTMF view shows folders and documents associated with the trials, countries, and sites to whichyou have access. The folder structure is based on the Drug Industry Association (DIA) referencemodel zones and sections within each level (trial, country, or site). When you select a folder inBrowse, the documents within that folder appear in the Doc List.

You can search for documents by product (compound), clinical trial, country, site, and documenttype. You can perform ad hoc searches by typing text to locate documents. For example, if youtype Principal, the search returns all documents containing Principal. You can export your searchresults lists to Microsoft Excel.

Finding Documents1. Click Find Documents.


111

Inspect a Trial

3. Click Run.

Finding Documents using FacetsThe faceted navigation includes two components, a Facet widget and a breadbox in the Doc Listwidget. The Facet widget allows search refinement in a dynamic facet list. Facets are grouped bycategory and ordered based on the configuration or advanced search settings.

The Doc List widget contains the breadbox to display the facet selections in the same order it is usedfor refinement. The breadbox is hidden if no facet value is selected or if all the values are cleared.The facets are categorized as standard and structured facets. The standard facets are single selectionfacets. The structured facets are hierarchical. When a user selects a facet value in the Facet widget, allthe facets are refreshed, the selected category reflects the selected facet value and removes the otherfacet values. A new set of facets available for the new results is displayed.

The EMC Documentum D2 User Guide provides more information about using faceted search, thesearch ratings, and results.

To perform a faceted search:

1. Click Browse.

2. Click the Doc List widget.

3. In the Quick Search box, type the name of the document you want to search and click Search.

4. Click the Facet widget to view the faceted search results.

Viewing Documents and their Properties1. Select a document in the Doc List to view it in the Document Viewer. If the PDF viewer of your

browser allows printing, you can print the document directly from the Document Viewer.

2. To view the document properties, click the Properties tab next to the Document Viewer.

Viewing Documents Side-by-sideThe Concurrent View enables you to view the content of two documents at the same time.

1. Right-click a document and select View in Viewer 1.

2. Right-click another document and select View in Viewer 2.

112

Inspect a Trial

Adding Notes1. Right-click a document or a folder and select Add note.

2. Type a comment and click Post.

Viewing and Deleting Notes1. To view a note, select a document and click the Notes tab.

2. To delete a note, mouse over the note and click Delete.

Viewing the Document HistoryThe document history, also known as the audit trail, shows information on what has happenedto the document. It includes lifecycle state changes, such as changing from Index (Draft) to Final(Effective) and any document property value changes.

1. Click the eTMF button and select a document.

2. Click the Audit tab. The audit trail shows relevant information for the selected document.

Deleting and Restoring a DocumentTo delete a document in D2 Client, you must install the D2-Bin plugin, which adds recycling bincapabilities to D2 Client. The EMC Documentum D2 Installation Guide provides the steps for installingthe plugin.

Follow these steps to delete and restore a document:

1. Log in as a member of the Author or Document Coordinator group.

2. Click Browse.

3. In the Browser, navigate to the folder containing the document you want to delete.

4. In the Doc List, right-click the document that is in the Draft or Index state and click Delete.

5. In the Delete dialog box, select one of the following options:• Delete selected version only: Deletes the current version of the document.

• Delete all versions: Deletes all major and minor versions of the document.

6. Click OK. The document is deleted and placed in the Recycle Bin.

7. To restore a deleted document, in the Recycle Bin, right-click the document and click Restore.

Note: Documents that are purged from the Recycle Bin cannot be restored. Only users incd_admingroup can purge the Recycle Bin.

113

Inspect a Trial

Export the Doc List to Microsoft ExcelYou can export the list of files in the Doc List to a Microsoft Excel spreadsheet.

1. Right-click the Doc List tab and select Export to Excel.

2. Select a location for the file on your local file system.

Additional Menu FunctionsIn addition to the standard Documentum D2 menu functions (Checkout, Edit, Check in, CancelCheckout, and so on) and the lifecycle state transition functions described in the Lifecycles section,the following additional menu functions are available. These functions do not change the statusof the selected object.




Additional Menu Functions for Trial Registration Forms

These menu functions apply to Trial Registration Forms only and are restricted to the designated TrialManagers. These menu functions require end-user confirmation.

The following table describes the Trial Registration Form menu functions:

Trial Registration Formmenu function

Description

Load / Reload File Plan Generates the default file plan based on the file plan templates associatedwith the relevant Product, Country, and Site Registration Forms,including the file plan template for the Trial Registration Form. (TrialRegistration Form Lifecycle Model) provides additional information.

Validate Validates the current file plan, but does not activate it. The Validatefunction applies to Trial Registration Forms in the Planning state. To usethis function, the Trial Registration Form must have a file plan definedfor it in Microsoft Excel 97-2003 format (.xls format) stored as the maincontent file in Documentum. File plans do not support Microsoft Excel2007 and 2010 format (.xlsx format). You can use Microsoft Excel 2007or 2010 to view, edit, and save file plan spreadsheets, but you mustsave them as Microsoft Excel 97-2003 files before checking them intoDocumentum.

After validating the file plan, the system records the validation resultsin the Validity column of the file plan spreadsheet. You can review the

114

Inspect a Trial

Trial Registration Formmenu function

Description

validation results by opening the Trial Registration Form content filein Microsoft Excel.

Progress Summary Provides a summary of the overall progress for the trial for all stagesup to and including the current active stage, plus a breakdown of theprogress of each stage, including the start and end dates. If the trialis time constrained, the specified planned start and end dates appearalong with the overall risk condition code (Green, Amber, or Red). TheProgress Summary function applies to Trial Registration Forms that arein the Active or Completed states.

Adjust Schedule Enables you to verify and adjust the schedule. You can specify thenumber of planned stages, the auto-activation and rollover options,the activation limit (product, trial, country, or site level), and whetherthe trial is time constrained. If the trial is time constrained, you canalso specify the planned start and end dates for each stage. The AdjustSchedule function applies to Trial Registration Forms that are in thePlanning or Active states.

Rollover to Next Stage Enables you to activate the next stage, regardless of whether thecurrent stage or preceding stages are incomplete. This function createsadditional placeholders for the artifacts planned for the next stage.The overall level of progress may suddenly diminish as a result. TheRollover to Next Stage function applies to Active trials with more thanone stage, where the stages activate in sequence and the currently activestage is not the last stage.

Update Trial Info Enables you to change trial-related information in the clinical trialregistration form. The system updates the relevant documents. TheUpdate Trial Info function applies to Trial Registration Forms that arein the Planning, Active, or Completed states.

Reassign to Product Enables you to move a trial and its associated documents andregistration forms to a different product. The system also applies thesechanges to historic versions of the objects. The Reassign to Productfunction applies to Trial Registration Forms that are in the Planning,Active, or Completed states.

115

Inspect a Trial

Additional Menu Functions for TMF Placeholders

These menu functions apply to TMF placeholders, but not documents.

The following table describes the TMF placeholder menu functions:

TMF Placeholder menufunction

Description

Import / File* Enables a content file upload from the local file system. If you do notselect anything in the browser, you must fill in all of the details onthe Classification page so that the system knows which artifact (TMFdocument type) to create, where to file it, and how it to name it. If youpreselect a placeholder or existing TMF document in the browser, itautomatically inherits the relevant properties from the selected item andit is not necessary to fill in the information.

Import / New Version* Enables a content file upload from the local file system for the selectedplaceholder. If the selected placeholder is for a repeatable artifact, thesystem creates the file as a separate document beside the placeholderwith the next item number in the sequence starting from .01. The sameplaceholder is available to upload additional documents. Otherwise, thesystem creates the file as a new version of the placeholder. In both cases,the status of the new document or version resets to Draft.

Omit Enables you to mark a placeholder as Omitted if you do not intend toprovide a corresponding document or set of documents for it. Theselected placeholder must be in the Recommended or Optional state.You cannot mark Required placeholders as omitted and documents arerequired. For Recommended placeholders, you must specify the reasonfor the omission. A reason is not necessary for Optional placeholders.

Reinstate Enables a placeholder that is currently marked as Omitted to revert to itsprevious state (Recommended or Optional) so that you can provide adocument or set of documents for it.

Properties Enables you to modify placeholder properties if you have theappropriate permissions. For example, expected and actual documentcount, TMF zone, section, artifact number, and artifact name. You canonly modify the expected document count for a TMF placeholder if theplaceholder is for a repeatable artifact.

*The Import function is available on the menu bar.

You can import files using drag and drop. Drag the file from the local file system and drop it intothe Documentum D2 Browser widget (the tree view panel). It does not matter where you dropthe file because it auto-files in the appropriate folder. You can preselect a placeholder or existingdocument in the browser before using drag and drop and the document inherits the relevantproperties automatically.

116

Inspect a Trial

Additional Menu Functions for TMF Documents

These menu functions apply to TMF documents, but not placeholders.

The following table describes the TMF document menu functions:

TMF Document menufunction

Description

Purge interim versions Removes all historic versions of the document that are in the Draft state,For Review, For Approval, or Withdrawn state. It does not removethe current version. This function is available with the selection of thecurrent version and is restricted to the Document Coordinators andAuthors of the document.

Share across sites Enables you to link a site-level document to additional site-level foldersor unlink them from those folders, if necessary. The selected documentmust be a site-level document in the TMF.

Reassign roles Enables users to adjust the current role settings for all future performers.For TMF (Control Category 3) documents, the user must be either anAuthor or Document Coordinator. The system audits role changes.

Adjust Effective /Review / Expiry dates

Enables users to modify the effective (Final) date, review date, andexpiry date settings for the selected document. For Control Category 1and 2 documents, the user must be a Document Coordinator in orderto use this function. This option is not available for Category 3 TMFdocuments.

Properties Enables you to modify basic properties of the selected document if youhave the appropriate permissions. For example, title, TMF zone, section,artifact number, artifact name, and keywords.

Advanced Properties Enables you to modify the full properties of the selected document if youhave the appropriate permissions. In addition to the basic properties,you can modify the inherited trial and product information, processinformation, role settings, and other document-specific information suchas current state, version number, last modifier, and modify date.

You can also configure sharing across sites as an alternative to using theShare across sites function.

The system audits any changes to document role settings.

Hard Delete Enables a Clinical Document Coordinator or any user with sufficientaccess rights to remove documents permanently from the system. Forexample, a trial reaches the end of its retention period and the ClinicalDocument Coordinator permanently removes those trial documentsfrom the system. Only documents in the Withdrawn lifecycle state canbe hard deleted. The user must provide a reason for every documentthat they hard delete. When hard deleting multiple files, one reasoncan cover all of them.

117

Inspect a Trial

TMF Document menufunction

Description

Caution: It is not possible to recover hard deleted documents.

118

Chapter 9Find Documents

Field settings on the Classification tab in the Properties dialog box determine the folders in which thesolution stores documents. Because the directory structure is multi-layered, use the Documentum D2advanced search methods described in the EMC Documentum D2 User Guide or the searches that arespecific to Documentum eTMF to find documents. You can find the queries specific to DocumentumeTMF in the Searches > Public Searches folder.

Documentum eTMF also provides an optional reporting feature for monitoring active clinicaltrials based on the euroscript Documentum Report Generator (eDRG). These reports only appearif they are included in the solution. The EMC Documentum for Life Sciences Reports Guide providesinformation on the reports.

The following table describes the Documentum eTMF search queries:

Query name Applicable roles forviewing the report

Description

Find Clinical Trial Documentsor Placeholders

ClinicalContributors,Authors, andCoordinators

Trial Managers

Finds TMF documents, includingplaceholders. Can be restricted to specificcountries, sites, or artifact names.

Find Clinical Trial Documentswith Document Filters

ClinicalContributors,Authors,Coordinators,Reviewers, andApprovers

Readers, andAuditors

Trial Managers

Finds TMF documents. Can be restrictedto specific countries, sites, or artifactnames.

119

Find Documents


Description

Find Registration Forms Contributors,Authors, andCoordinators

Trial Managers

ExternalContributors andInvestigators

Finds all registration forms includingproduct, trial, country, and site registrationforms.

Find Clinical Trials by Name,ID, or Product Code


Reviewers andApprovers

Readers

Trial Managers

Finds clinical trial registration forms.A summary of the status and currentprogress of each matching trial is shown.

Find Clinical Trials by Product ClinicalContributors,Authors, andCoordinators

Reviewers andApprovers

Readers

Trial Managers

Finds clinical trial registration forms basedon a selected product.

Find Delete Audit Events Clinical Authorsand Coordinators

Trial Managers

Provides a list that includes withdrawnand/or hard deleted documentsfor a specified date range. Harddeleted documents show theevent name cdf_hard_delete, whilewithdrawn documents list thed2_change_state_success event.

For cdf_hard_delete event entries, Value1shows Hard-Deleted and Value2 showsthe previous status of the document beforebeing hard deleted. Values 3, 4 and 5show the audited attribute values of thedocument in pairs of two each, if yourAdministrator configured them in theTMF Doc Delete Config - Attributes toAudit list.

120

Find Documents


Description

Deleting Documents Permanently, page104 provides more information.

Find Effective / FinalDocuments by Domain

Contributors,Authors,Coordinators,Reviewers, andApprovers

Readers

Clinical Auditors

Trial Managers

Finds documents in an Final lifecycle statebased on the domain of the document(for example, Procedure, Clinical,Non-Clinical, Quality, and Regulatory)and an optional keyword.

Find Effective / FinalDocuments

Contributors,Authors,Coordinators,Reviewers, andApprovers

Readers

Trial Managers

Finds documents in an Final lifecycle statebased on a specified product and keyword.

Find My Clinical TrialDocuments


Trial Managers

Searches for TMF documents authored orcoordinated by the user.

Find My Documents Contributors,Authors, andCoordinators

Trial Managers

Finds documents in which the current useris an Author or Document Coordinator.Users can specify a keyword to filterthe results. Only Authors or DocumentCoordinators can run this query and finddocuments.

Find Outstanding TaskParticipants

Authors andCoordinators

Trial Managers

Product Managers

Finds users that have not completed atask on a document that is currently in aworkflow.

121

Find Documents


Description

Find Sites for a Trial Contributors,Authors,Coordinators,Reviewers, andApprovers

Readers

Trial Managers

Lists the site registrations for a particulartrial.

Show Current WorkflowProgress

Authors andCoordinators

Trial Managers

Shows a list of workflow tasks for allrunning workflows for the selecteddocument.

122

Index

Aactivating a file plan template, 51activating a trial, 56activating the file plan for a clinical trial, 55adjusting the trial schedule, 55administer clinical trials, 31approving documents, 102associating

regulatory application, 78associating a file plan template with a

country registration form, 53associating a file plan template with a

product registration form, 52associating a file plan template with a site

registration form, 54associating a file plan template with a trial

registration form, 52audit a trial, 111audit trail, 97

Bbuilding the file plan for the trial, 54bulk export, 83bulk import, 83

starting, 89bulk import-export spreadsheet

populating, 88

Ccategorizing inbox tasks, 97checking in, 80clinical trial

audit, 111locking, 58

clinical trial country registration form, 36clinical trial registration form, 34

crossover documents, 35clinical trial site registration form, 37clinical trials

set up and administer, 31content template, 81control category

viewing, 106control category 2 documents

expiry review, 105controlled documents, 75creating

clinical trial country registrationform, 36

clinical trial registration form, 34clinical trial site registration form, 37content template, 81file plan, 48file plan template, 49product registration form, 32TMF bulk import-export package, 84

creating a document, 76creating registration forms for the trial, 51crossover documents, 23

Ddefining information in registration

forms, 31delegating a task, 108

users, 110workflow supervisor, 109

Doc Listexport, 114

documentchecking in, 80collaborative editing, 98deleting, 113reviewing, 100reviewing feedback from

approvers, 102reviewing feedback from

reviewers, 101self-approve, 95

document changes

123

Index

consolidating, 99document history, 113document package ZIP file

importing, 89document status

viewing, 106document_id, 78documents

creating, 76finding, 71, 111hard delete, 104remove permanently, 104withdraw, 104

Documentum eTMFoverview, 9

drag and dropimport file, 69

Eediting a document in a workfllow, 98eTMF structure

updating, 58existing documents

registration form changes, 59export

Doc List, 114multiple documents, 83

external trial participant accessverifying, 47

external trial participants, 46registering, 46registrations, 44

Ffacets, 112file names, 78file plan

creating, 48validate, 55

file plan templateactivating, 51activation, 51creating, 49

file plan template updatesunderstanding, 18

file plan templatesunderstanding trial activation, 16

file plan validation, 54

file plansunderstanding, 13

findingdocuments, 71, 111, 119placeholders, 67

finding a registration form, 68

Ggiving access permissions

external trial participants, 46

Hhard delete documents, 104

Iimport

multiple documents, 83import and index trial documents, 65import and indexing process, 65import documents, 69import file

drag and drop, 69placeholder, 69registration form, 69

importingdocument package ZIP file, 89

inbox taskscategorizing, 97

indexing a documentDoc List, 70finalize indexing list, 70

inspector notesadding, 113viewing and deleting, 113

internal and external userssecurity considerations, 45

investigator workspace, 73

Kkey documents

site registration form, 74

Llaunch collaborative editing, 94launch review workflow, 95lifecycle model

124

Index

trial registration form, 21lifecycle states

registration forms, 38locking a clinical trial, 58

Mmenu functions

TMF documents, 117TMF placeholders, 116trial registration forms, 114

missing documentssite registration form, 74

multiple documentsimport, 83

Oomit a placeholder, 79overview

Documentum eTMF, 9

Pperformers

update, 108placeholder

import document, 74import file, 69investigator, 74omit, 79reinstate, 80types, 67

placeholder propertiesview, 68

placeholdersfile plan, 55finding, 67product-level, 57

populatingbulk import-export spreadsheet, 88

product registration form, 32progress tracking

understanding, 18

Rreassigning, 110reassigning roles, 108, 110reference document

create, 78

refreshingbulk import-export spreadsheet, 85eTMF structure, 58

registration formfinding, 68import file, 69

registration form changesexisting documents, 59

registration formsdefining document information, 31understanding, 15

registrationsexternal trial participants, 44

reinstate a document, 103reinstate a placeholder, 80reports

eDRG, 119restricting access to registration forms, 43review and approve trial documents, 91roles, 110

Ssearch

documents, 119security considerations

internal and external users, 45self-approve a document, 95set up clinical trials, 31share across sites

TMF document, 81site registration form

investigator, 73starting

bulk import, 89stop a workflow, 108 to 109superseded, 105suspending a document, 103

Ttask performers

update, 108TMF bulk import-export package

creating, 84TMF bulk import-export packaget

zip and export, 85TMF bulk import-export spreadsheet

refreshing, 85TMF document

125

Index

share across sites, 81TMF placeholders, 55

product-level, 57TMF structure

understanding, 10trial

activating, 56audit, 111locking, 58

trial progress, 58trial registration form

lifecycle model, 21trial schedule

adjusting, 55trial schedule adjustments

understanding, 20trial statistics, 58

Uunderstanding

file plan template updates, 18file plans, 13progress tracking, 18registration forms, 15TMF structure, 10trial activation with file plan

templates, 16trial schedule adjustments, 20

update task performers, 108updating eTMF structure, 58users

delegating a task, 110

Vvalidate

file plan, 55validation

file plan, 54verifying

external trial participant access, 47

view document properties, 112view documents side-by-side, 112view placeholder properties, 68viewing clinical trial progress, 58viewing control category, 106viewing document status, 106viewing the audit trail, 97viewing workflow progress, 107

Wwithdraw documents, 104workflow

stopping, 108 to 109workflow process, 91workflow progress

viewing, 107workflow supervisor

delegating a task, 109workflow tasks

approving documents, 102editing documents, 98reinstate a document, 103reviewing documents in a Review

task, 100reviewing feedback from

approvers, 102reviewing feedback from

reviewers, 101superseded documents, 105suspending a document, 103update performers, 108

workflowslaunch collaborative editing, 94launch review, 95performing tasks, 95

Zzip and export

TMF bulk import-export package, 85

126