A Web Based Protocol Writing SystemA Web Based Protocol Writing System

ProtoTypeProtoType::A New Tool for AuthoringA New Tool for Authoringand Managing Clinicaland Managing ClinicalProtocols Developed at the CCProtocols Developed at the CCPresented by Philip LightfootPresented by Philip Lightfoot

National Institutes of Health, Clinical CenterDepartment of Clinical Research Informaticsand Protocol Management ServicesBethesda, MarylandFebruary 22, 2010

Agenda Agenda –– Topics to DiscussTopics to Discuss

- What is ProtoType?

- Overview of ProtoType’s Features

- Value Added for the Researcher

- Usage Statistics

- Where We’re Going - Future Development

Why Why ProtoTypeProtoType??ProtoType was created for several reasons…

- Writing a clinical protocol is hard work.

- Currently, there is little standardization between

protocols.

- NIH policies and regulations can change requiring

updates to several forms in the protocol.

- Paper protocols are large, and costly to print out

many times.

- Training tool – Learning how to write a protocol is

awkward and difficult.

What is What is ProtoTypeProtoType??

Features of Features of ProtoTypeProtoType- Fully customized documents tailored toward

individual IRBs.

- Investigators focus on authoring - ProtoType takes

care of the rest.

- Full version history of the entire protocol for both

internal and external review.

- Support for full collaboration among investigators in

every aspect of protocol authoring.

Customization and FlexibilityCustomization and Flexibility

- Format is NIH IRB-specific- Only relevant fields appear (e.g. Natural

history study vs. Clinical Trial study)- Recommended language cassettes can be

designated for all parts of the protocol- Rapidly integrates new NIH policies.

Ease of UseEase of Use

-- Single SignSingle Sign--on (NIH standard login).on (NIH standard login).

-- Full Microsoft Word Compatibility.Full Microsoft Word Compatibility.

-- Portable images (cut & paste from anywhere).Portable images (cut & paste from anywhere).

-- Protocol image library for use throughout the Protocol image library for use throughout the protocol.protocol.

-- Robust Reference Management.Robust Reference Management.

-- Supports import from Supports import from QuosaQuosa Reference Manager, and Reference Manager, and PubMedPubMed..

Creating a ProtocolCreating a Protocol

Protocol LayoutProtocol Layout

Using Standard LanguageUsing Standard LanguagePrePre--Loaded Standard LanguageLoaded Standard Language

Principal InvestigatorPrincipal InvestigatorWelcome to Welcome to ProtoTypeProtoType

My ProtocolsMy Protocols

Edit FeaturesEdit FeaturesOpening the EditorOpening the Editor

Edit FeaturesEdit FeaturesEditor OverviewEditor Overview

Edit FeaturesEdit FeaturesAdding a ReferenceAdding a Reference

To add a reference, mouse over the

reference and click.Reference added to the text.

Edit FeaturesEdit FeaturesAdding an ImageAdding an Image

Images can be pasted into the text, or from your image library. To add an image click on the

“Insert Image” button.

Clicking this button

displays images

specific to this protocol.

Images can be chosen from

your computer.

Protocol images are listed here.

Click Okay to Insert

the image.

Edit FeaturesEdit FeaturesAfter the Edits Before the EditsAfter the Edits Before the Edits

Help FeaturesHelp FeaturesOpening Help LanguageOpening Help Language

Click the Help button to get

context specific help.

A new window opens with help specific to that

section.

Track Changes and FeedbackTrack Changes and Feedback

ProtoTypeProtoType supports three different methods for supports three different methods for reviewing the protocol and providing feedbackreviewing the protocol and providing feedback……

-- Integrated track changes in the editor.Integrated track changes in the editor.

-- The ability to compare protocols at different The ability to compare protocols at different dates or different actions (i.e., comparing dates or different actions (i.e., comparing ‘‘07 CR 07 CR against an against an ’’08 CR).08 CR).

-- Fully featured feedback and comment system Fully featured feedback and comment system from cofrom co--authors, reviewers, etc.authors, reviewers, etc.

Editing the ProtocolEditing the ProtocolIntegrated Change TrackingIntegrated Change Tracking

Red Text has been edited by

Philip Lightfoot.

Blue text has been edited by John Doe,

M.D.

Version History ComparisonVersion History ComparisonComparing protocols across time.Comparing protocols across time.

Click here to compare versions.

Old Text Crossed Out And In Red.

New Text Colored Yellow.

Current Version of the

Protocol

Version Being Compared

Against

Protocol FeedbackProtocol FeedbackComment CreationComment Creation

Change tracked edition

ready for review.

Full comment chain directly in

body of protocol.

-- Recommended Language Cassettes for protocol body and consent Recommended Language Cassettes for protocol body and consent forms.forms.

-- Online archive of all Online archive of all PIPI’’ss protocols.protocols.

-- Amendments immediately incorporated into protocol.Amendments immediately incorporated into protocol.

-- Protocol moves electronically to IC, IRB, CC, etc.Protocol moves electronically to IC, IRB, CC, etc.

-- IRB can recommend language changes.IRB can recommend language changes.

-- Tracks states of the protocol, i.e. Amendment, Continuing RevTracks states of the protocol, i.e. Amendment, Continuing Review, and iew, and Termination.Termination.

-- Template updated based on NIH policies/regulatory changes, i.Template updated based on NIH policies/regulatory changes, i.e. COI.e. COI.

-- Continuing review report Continuing review report -- Summary of amendments and protocol Summary of amendments and protocol changes.changes.

Value Added for the ResearcherValue Added for the Researcher

17

Coming SoonComing Soon

-- Integration with IC Systems.Integration with IC Systems.

-- Improved collaborating site interface to assist 1195 prep.Improved collaborating site interface to assist 1195 prep.

-- IND Wizard coIND Wizard co--developed with FDA.developed with FDA.

-- Adverse Event Reporting.Adverse Event Reporting.

-- Assisted Compliance with Public Law 110Assisted Compliance with Public Law 110--85.85.

-- NIDDK, NHGRI, and other templatesNIDDK, NHGRI, and other templates

-- …… and many more.and many more.

Where WeWhere We’’re Goingre Going

ProtoTypeProtoType ContributorsContributors

- Dr. Barbara Karp (NINDS)- Kim Jarema (CC)- Dr. Hans Ackerman (CC)- Dr. Richard Cannon (NHLBI)- Dr. Codrin Lungu (NINDS)- Dr. Robert Nussenblatt (NEI)- Philip Lightfoot (CC)- Dr. Jon McKeeby (CC)- Ryan Kennedy (CC)- Dr. Aviva Ellenstein (NINDS)

- Dr. Sara Hull (NHGRI)- Dr. Stephen Rosenfeld (CC)- Heather Bridge (NIAID)- Patricia Magno-Sweet (NHBLI)- Bill Barrick (NIAID)- Dr. Marcus Heilig (NIAAA)- Elaine Ayres (OD)- Dr. Ekaterina Tsilou (NEI)- Dr. Juan Lertora (CC)- Dr. James Cimino (OD)

And many more….!

ProtoTypeProtoType

We encourage you to use ProtoTypeProtoType

To visit ProtoType go to…http://prototype.cc.nih.gov

The link is also available from the OPS website…http://intranet.cc.nih.gov/ops/links.html

ProtoTypeProtoType ContactsContacts

Phil Lightfoot Kim Jarema(301) 496-3343 (301) 435-2401

plightfoot@mail.nih.gov kjarema@mail.nih.gov

Ryan Kennedy(301) 402-4867

kennedyr@cc.nih.gov