eTMF IMPLEMENTATION CHECKLIST - ComplyDocs

eTMF IMPLEMENTATION CHECKLIST

A q u i c k - s t a r t g u i d e t o h e l p y o u t h r o u g h a n e T M F I m p l e m e n t a t i o n

Prepared by ComplyDocshttps://complydocs.com

https://complydocs.com/

About this checklist

This eTMF Implementation Checklist is a quick-start guide which provides a list of

questions to ask and ideas to consider when creating an eTMF Implementation plan.

Use it to get started when looking for eTMF solutions, to integrate into your own planning

documents, or simply to look for ways to improve your existing TMF processes.

ComplyDocs – https://complydocs.com

Table of ContentGet a quick overview of this guide.

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Roles & Responsibilities

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05

TMFContent

Page

07

TMFQuality

Page

12

TMF Oversight

Page

15

TMF Archiving

Page

20

Access & Security

Page

22

Summary

Page

24

Introduction

Page

04


IntroductionYour eTMF Implementation Plan

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TMF CONTENT: The new system uses the TMF Reference Model to categorize

documents - how do I switch over to a new filing structure? It can also collect and

display far more information (or metadata) about my documents than before -

how am I going to make use of this? How will my TMF staff adapt to these

changes?

TMF QUALITY: How will my QC process be affected by this change? Are my SOPs,

work instructions, etc. still relevant? What about our filenaming and document

identification standards? How do we ensure a high-quality archive at study close?

And again, how can my TMF team get acclimated to these changes?

TMF OVERSIGHT: Our plans for all of the above won’t matter if we can’t clearly

define the right roles to do it, or then track and measure our success. Who will be

responsible for doing what in the new system? What training do they need? What

metrics do we want to track (e.g. for TMF completeness, quality, timeliness), and

is this info readily available in the eTMF itself?

The benefits of switching to a purpose-built eTMF are

now well-established: gaining better insights into TMF

completeness, quality, and timeliness; reducing time

spent on manual tasks (for examples, document

tracking, or assigning and performing QC); simplified

document sharing and processing; role-based access for

secure document sharing; and many more. It all adds up

to a more efficient and high-quality TMF.

However, these benefits will not magically appear once

the decision to switch to eTMF is made - there are still a

number of roadblocks ahead. For example, you may be

faced with difficult questions regarding:

These are just some of the questions you may be faced with when making the switch.

The key to answering them (and more) is by having a solid eTMF implementation

plan, to ease this transition and give yourself the best chance of success.


This section of the plan might define or describe:


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Prior to using an eTMF, your roles and responsibilities might have involved defining who collects files, who does QC, who is informed of various TMF-related events, and more. How does the switch to eTMF impact this?

Fortunately it’s not too difficult - you can start comparing what your TMF roles and responsibilities typically involve to the specific user roles and access privileges offered by an eTMF system.

At minimum, this role-based access will offer at least 3 distinct roles:

1. a read-only option (for staff who need to observe, or for an auditor),

2. a contributor option (user can upload and view content), and3. a management option (user can assign tasks, perform QC

review, etc.).

❑ What user roles are available in the eTMF, and what type of access or privileges are granted to each role

❑ Which staff/team members will have access to the eTMF

❑ Which eTMF user role is most appropriate for each person

❑ If eTMF access will be granted to inspectors, how will this be handled

TMF Content


TMF Content

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Sources of Content

TMF content will originate from many different systems over the course of a trial.

An eTMF provides the opportunity to centralize and manage that content in one place, but first, it’s necessary to plan out what content exists and where.

❑ Where your TMF content will come from (e.g. Sponsor, sites, labs, IRBs, CROs, and more)

❑ How you use the eTMF to track where the content came from

❑ What form your documents exist in (paper, electronic, or both)

❑ How will you indicate if a document is the authoritative, inspectable version (alternatively, if it’s a copy of an original which resides elsewhere)

This section of the plan might outline or provide guidance for:

TMF Content

9

Classification Scheme

Prior to moving to an eTMF, you may have used a custom-built in-house filing plan for categorizing your TMF documents.

However, most purpose-built systems now come with built-in support for the TMF Reference Model, a useful standard for organizing TMF content.

❑ Mapping your custom, in-house filing plan to the TMF Reference Model

❑ Defining which “levels” are documents filed at (e.g. Study, Country, or Site)

❑ Deciding which document types, or “TMF Artifacts”, are expected for each filing level

https://tmfrefmodel.com/resources

This section of your plan might describe how to capture and make use of information related to your documents:

TMF Content

10

Other Document Attributes (Metadata)

A major benefit of adopting an eTMF is being able to collect, store, and view a rich amount of information about your documents electronically. This document metadata is great for retrieval, sharing, and tracking in reports.

So, now that you’re moving to an eTMF, you should determine what information you wish to collect about your documents, and how you wish to use such information.

❑ Sites or Investigators

❑ Dates (e.g. Effective, Expiry, Uploaded, Reviewed)

❑ Versions

❑ Naming Conventions (note: an eTMF system should be able to enforce these automatically!)

❑ QC review details and other user comments

This section of the plan might outline the following:

TMF Content

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Emails

Emails are notoriously difficult to manage in TMFs, especially when deciding what should be filed and where to keep it. You may have large, unorganized email folders or PST files as a result.

An eTMF can help manage this with the correct planning by providing one central repository and easy uploading features so you can file emails on the go.

❑ Criteria for deciding if an email is TMF-relevant

❑ Where these emails will be stored

❑ What format they will be stored in (.msg, PDF, etc.)

❑ If stored directly in the eTMF, how they can be linked to any attachments or other related material

TMF Quality


TMF Quality

13

Document Reviews

Moving to an eTMF gives you the opportunity to streamline your document review process. You just have to sync up the correct quality standards and criteria (e.g. ALCOAC) with new features and tools that the eTMF offers.

First, you’ll want to consider how the new eTMF will impact your previous review and QC processes and adjust accordingly.

❑ Who is responsible for performing QC review (can also be defined in Roles and Responsibilities)

❑ What are your standards or criteria for ensuring document quality

❑ What other “extra” criteria or standards are required as a result of using an eTMF (e.g. documents have correct metadata, eTMF reports are reviewed on a defined schedule, etc.)


TMF Quality

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Document Lifecycle

The main quality tool an eTMF will offer is a built-in document workflow which helps you track the status of each item, from creation to final approval.

❑ What are the “steps” in this workflow (e.g. Awaiting Review, Flagged by QC Review, Final…)

❑ What are the criteria for advancing a document through each step, and who can perform this action (you may sync this up with your Review process and standards described in the previous section)

❑ How to replace a document with a new version (i.e. due to expiry or other quality issues) and track this using version history or audit trail

TMF Oversight


TMF Oversight

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Reports

Now that your plans for Content and Quality are in place, you want to ensure they are actually carried out. An eTMF system should provide several tools which assist with this TMF Oversight.

One of the biggest changes when moving to an eTMF is not having to manually track your TMF’s completeness, timeliness, and quality manually - for example, in a spreadsheet.

An eTMF will simplify this with automated reports - so it’s important to figure out what you want to track.

❑ Your study’s significant Milestones (e.g. site start-up)

❑Which document types (TMF Artifacts) are expected at each Milestone

❑ Significant Events and their impact on TMF documents (e.g. if there is an Investigator change, what document types are affected?)

❑ How the documents related to Events and Milestones is tracked in eTMF reports

❑ Any other metrics or KPIs that will be tracked (i.e. related to TMF completeness, timeliness, and quality!)

This section might describe how you will be notified of:

TMF Oversight

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Notifications

Now that you’re capturing more useful info about your documents with an eTMF, you can use it to be automatically notified by the system of important TMF-related events.

❑ Document approaching expiry or has expired

❑ Documents being flagged by QC reviewers

❑ New assignments or review tasks being created

❑ New files uploaded

❑ Any other noteworthy TMF events

This section might describe how you can retrieve documents by:

TMF Oversight

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Document Retrievals

In a paper or shared-drive TMF system, you had to remember the exact location of a file to retrieve it. An eTMF should offer the ability to locate something based on what it is, not where it was stored. In other words, you can use filters, keywords, and views to browse and retrieve documents instantly.

What are the most useful ways to browse your new system?

❑ Browsing by document levels, countries, or sites (Study, Country, or Site)

❑ Browsing by a tree of TMF Artifacts (if using the TMF Reference Model)

❑ Browsing by document status (e.g. eTMF can display all documents that are awaiting QC review)

❑ By other important document info (e.g. by uploaded or expiry dates, by version, etc.)

❑ Using a keyword search to retrieve documents with those words in the titles, metadata, or within the documents' actual text

This section might describe how you can complete or create tasks such as:

TMF Oversight

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Assignments

Where assignments and tasks used to be generated manually (i.e. via email), an eTMF will offer the ability to generate and complete tasks all entirely within the system itself.

❑ Scheduled QC review

❑ Identifying and uploading expected documents

❑ Correcting documents with quality issues

❑ …and any other important TMF-related tasks (inspect your SOPs or consult with the team to ensure all the essential ones are identified)

TMF Archiving

This section might cover the following issues:

TMF Archiving

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Archiving an eTMF will require some adjustments from your previous processes for a paper or a file-share system.

There are a lot of issues this section might address - here’s a sample of a few important ones:

❑ Which SOPs, policies, or regulations apply to the eTMF archiving process

❑ How long will the eTMF stay online and accessible after study close

❑ Where will the eTMF be archived (e.g. with the vendor, in your own systems environment…)

❑ If necessary, can a system-neutral export or copy of your eTMF content be produced

❑ Is any file conversion, transformation, or migration required?

TMF Access & Security

Get Notified

TMF Access & Security

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This is an essential part of an eTMF implementation project. Topics covered would include: • role-based access• security standards• regulatory requirements• computer systems validation

Due to the importance of TMF Access & Security, we will be publishing a stand-alone guide dedicated to this one topic.

To receive this guide once it is published, please use the notification process to the right.

❑ To get notified once the stand-alone eTMF Access & Security Checklist is published, simply email your request HERE:

mailto:[email protected]?subject=eTMF-Access-Security-Checklist-Request


Don’t expect a plug and play solutionLay the foundation for change. You

must map your current processes to

the new technology and manage the

change accordingly.

Establish a checklist and follow itBreak down crucial tasks and

projects into manageable parts.

Ask questionsYour checklist will lead to asking the

right questions that can help set a

clear direction towards a successful

eTMF implementation.

Following a detailed checklist leads to more effective implementations.

A successful eTMF is much more than just a “plug and play” solution - it’s important to first lay

a good foundation for the change. That goes for all phases of your implementation project -

from deciding what you want to get out of a new system, to evaluating and selecting one,

through to putting it in play and getting your users involved.

That’s where a focused, detailed checklist approach like this one can help immensely.

Breaking down your high-level concerns and requirements (such as TMF Content, Quality,

Timeliness, etc.) gradually into smaller pieces gives you the insight you need about what you

really want to get out of your new system.

This results in asking the right questions for eTMF selection, having clear plans for

implementation, mapping your old processes to a new technology, and setting clear direction

for your users - all essential for a successful eTMF.

IN SUMMARY

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About ComplyDocs

Leveraging 35 years of Clinical Trial experience

ComplyDocs is no ordinary eTMF vendor. We are a wholly owned subsidiary of McDougall

Scientific, one the more experienced pharma statistical analysis and data management

consulting firms around with over 35 years of Clinical Trial experience. ComplyDocs leverages

this experience to help clients minimize the risk and complexity of managing large amounts

of clinical trial documents. ComplyDocs manages your trial documents with the same

sophistication as its sister company, McDougall Scientific, manages your data.

ComplyDocs is known as a powerful eTMF that is easy to use, quick to implement and

affordable to deploy.

www.complydocs.com

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Click HERE to view ComplyDocs Demos.

mcdougallscientific.com

https://complydocs.com/view-demos

eTMF IMPLEMENTATION

CHECKLIST

A q u i c k - s t a r t g u i d e t o h e l p y o u t h r o u g h a n e T M F

I m p l e m e n t a t i o n

Prepared by ComplyDocsComplydocs.com

complydocs.com