ProtoType: A New Tool for Authoring and Managing Clinical Protocols Developed at the CC

Transcription

1 A Web Based Protocol Writing System ProtoType: A New Tool for Authoring and Managing Clinical Protocols Developed at the CC Presented by Philip Lightfoot National Institutes of Health, Clinical Center Department of Clinical Research Informatics and Protocol Management Services Bethesda, Maryland February 22, 2010

2 Agenda Topics to Discuss - What is ProtoType? - Overview of ProtoType s Features - Value Added for the Researcher - Usage Statistics - Where We re Going - Future Development

3 Why ProtoType? 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.

4 What is ProtoType?

5 Features of ProtoType - 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.

6 Customization 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.

7 Ease of Use - Single Sign-on (NIH standard login). - Full Microsoft Word Compatibility. - Portable images (cut & paste from anywhere). - Protocol image library for use throughout the protocol. - Robust Reference Management. - Supports import from Quosa Reference Manager, and PubMed.

8 Creating a Protocol

9 Protocol Layout

10 Using Standard Language Pre-Loaded Standard Language

11 Welcome to ProtoType Principal Investigator My Protocols

12 Edit Features Opening the Editor

13 Edit Features Editor Overview

14 Edit Features Adding a Reference Reference added to the text. To add a reference, mouse over the reference and click.

15 Edit Features Adding an Image Clicking this button displays images specific to this protocol. Protocol images are listed here. Click Okay to Insert the image. Images can be chosen from your computer. Images can be pasted into the text, or from your image library. To add an image click on the Insert Image button.

16 Edit Features After the Edits Before the Edits

17 Help Features Opening Help Language A new window opens with help specific to that section. Click the Help button to get context specific help.

18 Track Changes and Feedback ProtoType supports three different methods for reviewing the protocol and providing feedback - Integrated track changes in the editor. - The ability to compare protocols at different dates or different actions (i.e., comparing 07 CR against an 08 CR). - Fully featured feedback and comment system from co-authors, reviewers, etc.

19 Editing the Protocol Integrated Change Tracking Blue text has been edited by John Doe, M.D. Red Text has been edited by Philip Lightfoot.

20 Version History Comparison Comparing protocols across time. Click here to compare versions. Version Being Compared Against Current Version of the Protocol Old Text Crossed Out And In Red. New Text Colored Yellow.

21 Protocol Feedback Comment Creation Change tracked edition ready for review. Full comment chain directly in body of protocol.

22 Value Added for the Researcher - Recommended Language Cassettes for protocol body and consent forms. - Online archive of all PI s protocols. - Amendments immediately incorporated into protocol. - Protocol moves electronically to IC, IRB, CC, etc. - IRB can recommend language changes. - Tracks states of the protocol, i.e. Amendment, Continuing Review, and Termination. - Template updated based on NIH policies/regulatory changes, i.e. COI. - Continuing review report - Summary of amendments and protocol changes. 17

23 Coming Soon - Integration with IC Systems. - Improved collaborating site interface to assist 1195 prep. - IND Wizard co-developed with FDA. - Adverse Event Reporting. - Assisted Compliance with Public Law NIDDK, NHGRI, and other templates - and many more.

24 Where We re Going

25 ProtoType Contributors - 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.!

26 ProtoType We encourage you to use ProtoType To visit ProtoType go to The link is also available from the OPS website

27 ProtoType Contacts Phil Lightfoot Kim Jarema (301) (301) Ryan Kennedy (301)