1/20/2015. ProtoType & Beyond: A History of Electronic Protocol Authoring at the CC Presented by Philip Lightfoot. Agenda Topics to Discuss

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Electronic Authoring ProtoType & Beyond: A History of Electronic Protocol Authoring at the CC Presented by Philip Lightfoot National Institutes of Health, Clinical Center Department of Clinical

1 Electronic Authoring ProtoType & Beyond: A History of Electronic Protocol Authoring at the CC Presented by Philip Lightfoot National Institutes of Health, Clinical Center Department of Clinical Research Informatics and Protocol Management Services Bethesda, Maryland January 20th th, 2015 Agenda Topics to Discuss Why Electronic Authoring? How ProtoType Came To Be? Overview of ProtoType s Features Challenges Faced In Adoption Where We re Going - Future Development Why Electronic Authoring? Why do we need a centralized electronic protocol authoring system? 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 How to do all of the above efficiently. 1

2 ProtoType History? History ProtoType was homespun by NIH investigators who envisioned a system that would 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. 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) And many more.! 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) 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-management programs. 2

3 What is ProtoType? Training Tool Protocol Review (CDs, SDs, IRBs, etc.) Standard Language Repository Centralized, Interactive Editing ProtoType Reference and Image Manager IND Wizard Facilitate New Policies and Regulations Informed Consent 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. 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. 3

4 And Now The Challenges Despite a robust tool set, ProtoType ultimately had trouble with adoption. Why? Three Things. 1.Competition 2.Change 3.Audience Challenge - Competition Everyone is used to Microsoft Word Word is simple yet offers as much complexity as a user wants Word is portable (no online requirement) Other ICs use their own internal systems Challenge - Change Related to Competition, most people are happy with what already works. If it s not broken, don t fix it. ProtoType required a completely new way of doing business and required a good deal of effort (multiple protocols and revisions) before the enhanced results became clear. 4

5 Challenge - Audience ProtoType tried to be all things to all people. This resulted in a great deal of complexity from the backend. Feature overload. ProtoType could be difficult to learn. What Now? In 2011, NINDS took over future development of ProtoType. ProtoType has become PAT (Protocol Authoring Tool) an add-on to PTMS (Protocol Tracking and Management System) Where We re Going Training Tool PAT Protocol Protocol Authoring Tool An add-on Review to PTMS (SDs, IRBs, etc.) Standard Language Repository Centralized, Interactive Editing Cost/Resource Projections PROTRAK ProtoType CRIS Reference and Image Manager IND Wizard Facilitate New BTRIS Policies and Regulations Informed Consent 5

2/22/2011. Why ProtoType? What is ProtoType? Overview i of ProtoType s Features Value Added for the Researcher Where We re Going - Future Development

2/22/2011. Why ProtoType? What is ProtoType? Overview i of ProtoType s Features Value Added for the Researcher Where We re Going - Future Development Agenda Topics to Discuss Why ProtoType? 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