1. REDCap Regulatory Binder
Lynn Simpson, MPH
Research Analytics & Data Services Manager
The Harvard Clinical and Translational Science Center
Partners HealthCare

2. What is the eReg Binder?
Is it successful?
How to implement at your site?

3. Harvard Catalyst – Partners HealthCare
Founding Members, Harvard Medical School Teaching Affiliates:
Brigham and Women’s Hospital
Massachusetts General Hospital
Support Funded by:
Harvard Catalyst | The Harvard Clinical and Translational Science Center
REDCap Success:
8,730 projects
4,574 production
2,300 protocols

4. REDCap Usage
Not just for Research

5. Partners Human Research Committee / IRB
The PHRC are authorized to review and oversee human-subjects research that is conducted by employees or agents (e.g., professional staff) of the BWH, FH, MGH, McLean and NSMC in connection with their institutional responsibilities, regardless of the location of the research or source of funding, in accordance with federal, state, and local laws and regulations.
Partners Human Research Quality Improvement (QI)
The Partners QI Program is committed to providing on-going support and education to the research community.
Not-for-cause / routine onsite re​​views
For-cause onsite reviews

7. Study Site Signature/Delegation of Responsibility Log

8. QI’s eReg Binder Requirements
• Data collection instruments that capture required regulatory information similar to what is generally captured in their “virtual” QI Regulatory Binder for all studies. • Branching logic that identifies and collects study specific regulatory information, such as laboratory certifications, and FDA forms. • A report builder for developing site specific reports including delegation of responsibility log, protocol amendment tracking log, and consent version tracking log. • A calendar for keeping track of due-dates for regulatory documents. • Ability for the PI to grant different levels of viewing/editing rights for study staff; sign delegation log.

9. REDCap eReg Binder Project
Main Factors for Success:
Study Teams already using REDCap
QI group driving the development
REDCap met almost all requirements “out of the box”
Deliverable:
REDCap project available as a Project Template
Data Collection Instruments:
IRB Review
Protocol
Staff Documents
Logs Delegation
Consent Form
Data Collection
Study Specific Documents
Report Plugins
Status: 183 QI Binders as of Jan 2015

18. QI Virtual Regulatory Binder

19. Delegation Log – Plug In

20. Protocol Version / Amendment Tracking Log – Plug In

21. Consent Form Version Tracking Log – Plug In

22. How to implement at your site?
Get Buy-in
IRB / Quality Improvement / Regulatory Group should define the use case and drive the development
Start with our template
Available on REDCap Community: eReg Binder Project
A REDCap Data Dictionary
Instruction Manuals
Protocol Version/Amendment Tracking Log plugin
Consent Form tracking plugin
Delegation Log plugin

23. How to implement at your site?
Promote it
Easy access via Create New Project > REDCap Project Templates
Regulatory group recommends use
Harvard Catalyst Promotion:

24. How to implement at your site?
Integrate it with institution systems
IRB Database -> REDCap
[ProtocolNumber]
[InsightProtocolId]
[PI_InsightAdmPersonID]
[PIUsername]
[PIDisplayName] …
Partners HealthCare Future State 2017:
IRB protocol and staff updates submitted to internal IRB database will populate REDCap eReg Binder (using API)
Eliminate redundant data entry
Increase eReg Binder usage for new protocols

25. References/Resources
International Conference on Harmonization. (1996). E6 Guideline for Good Clinical Practice. Retrieved from
Partners Human Research Committee. (2015). Guidance for Investigators Recordkeeping and Record Retention Requirements.
Code of Federal Regulations. (2014). 21 CFR Part 11 Electronic Records; Electronic Signatures. Retrieved from
Food and Drug Administration. (2007). Guidance for Industry Computerized Systems Used in Clinical Investigations. Retrieved from
Food and Drug Administration. (2013). Guidance for Industry Electronic Source Data Capture in Clinical Investigations. Retrieved from
Food and Drug Administration. (2003). Guidance for Industry Part 11, Electronic Records; Electronic Signatures – Scope and Application. Retrieved from