National Institutes of Health, Clinical Center Department of Clinical Research Informatics and Protocol Management Services Bethesda, Maryland

Transcription

1 A Web Based Protocol Writing System ProtoType: A New Tool for Authoring and Managing g Clinical Protocols Developed at th e CC Presented by Philip Lightfoot National Institutes of Health, Clinical Center Department of Clinical Research Informatics and Protocol Management Services Bethesda, Maryland February 22 nd, 2011

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

3 Why ProtoType? History ProtoType was homespun by NIH investigators who envisioned a system that wo ould handle all aspects of the protocol life cycle. ProtoType was originally outsourced for development to Stellar Systems. After two years of outsourcing, ProtoType was transitioned to in-house development.

4 Why ProtoType? ProtoType was created for several reasons Writing a clinical protocol is 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. hard work.

5 What is ProtoType? ProtoType is an assisted protocol authoring tool that Maximizes use of IT. Employs a paperless system. Standardizes protocol authoring while offering flexibility. Provides a standardized template for investigators. Improves resource allocation. Enhances integration of protocol with care. Facilitates the process for all. Increases speed of protocol writing and review. Consolidates other protocol-m management programs.

6 What is ProtoType? Protocol Training Review Tool (CDs, SDs, IRBs, etc.) Standard Language Repository Centralized, Interactive Proto otype Editing Reference and Image Manager IND Wizard Facilitate New Polici es and Regulations Informed Consent

7 Features of ProtoTyp pe Fully customized documents tailored toward individual id 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.

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

9 Creating a Protocol The Research Type and IRB fields determine the format, or layout, of the Protocol. When the Save button is formatted specifically for clicked the protocol will be NEI s Clinical Trial format.

10 Protocol Layout Protocol Containers are the second level of organization. Protocol Pages are the top level parts of the protocol. These correspond to the top-level entries in a protocol s Table of Contents. Containers can be further broken down into Components. These are the basic sections of a protocol and typically deal with a single idea.

11 Using Standard Lang guage g Pre-Loaded Standard Languag ge Standard language preloads when the consent is created.

12 Welcome to ProtoTy ype Principal My Protocols Investigator

13 Edit Features Opening the Editor Click the Edit Click the Edit button to edit information within the component.

14 Edit Features Editor Overview Word-like visual interface. One click inserts References and Recommended Language Cassettes

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

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

17 Edit Features Before After the the Edits

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

19 Track Changes and Feedback ProtoType supports thre ee different methods for reviewing the protocol and providing feedback Integrated track chang ges in the editor. The ability to compare protocols at different dates or different actio ons (i.e., comparing 07 CR against an 08 CR). Fully featured feedbac ck and comment system from co-authors, review wers, etc.

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

21 Version History Com mparison Comparing protocols across ti ime. Current Version of the Protocol Click here to compare versions. Version Being Compared Against Old Text Crossed Out And In Red. New Text Colored Yellow.

22 Protocol Feedback Comment Creation Change tracked edition ready for review. The comment body.

23 Value Added for the Researcher Recommended Language Casset ttes for protocol body and consent forms. Online archive of all PI s protocols s. Amendments immediately incorpo orated into protocol. Protocol moves electronically to IC C, IRB, CC, etc. IRB can recommend language cha anges. 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 - Summ ary of amendments and protocol changes. 17

24 Coming Soon Integration with IC Systems. Improved collaborating site i nterface to assist 1195 prep. Adverse Event Reporting. Assisted Compliance with Pu ublic Law NIDDK, NHGRI, and other emplates and many more.

25 Where We re Going NLM ClinicalTrials.gov PL Training Tool ProtoType Protocol Review Assisted protocol writing system Scientific and Regulatory Document Basic Clinical Care Plan (SDs, IRBs, etc.) Standard Conflict-of-Interest Report of Investigators Language (to ICD) g Repository Cost/Resource Projections Centralized, Interactive Editing Protocol Monitoring IND Wizard Protocol Mapping System Proto Type CRIS Facilitate New Policie BTRIS es and Regulations Adverse Events Reporting System CRIS-AE Reference and Image Manager Regulatory Agencies (FDA, OBA,etc) Informed Consent

26 ProtoType Contribut tors 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.!

27 ProtoType We encourage you to use ProtoType To visit ProtoType go to The link is also available from the OPS website nih h.gov/ops/links.html html

28 ProtoType Contacts Phil Lightfoot (301) Kim Jarema (301) Ryan Kennedy (301) 40