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

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

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

REDCap Usage Not just for Research

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

Study Site Signature/Delegation of Responsibility Log

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.

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

QI Virtual Regulatory Binder

Delegation Log – Plug In

Protocol Version / Amendment Tracking Log – Plug In

Consent Form Version Tracking Log – Plug In

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 https://github.com/PHSERIS/eReg-Binder A REDCap Data Dictionary Instruction Manuals Protocol Version/Amendment Tracking Log plugin Consent Form tracking plugin Delegation Log plugin

How to implement at your site? Promote it Easy access via Create New Project > REDCap Project Templates Regulatory group recommends use Harvard Catalyst Promotion: https://catalyst.harvard.edu/services/regbinder/

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

References/Resources International Conference on Harmonization. (1996). E6 Guideline for Good Clinical Practice. Retrieved from http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html 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 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11 Food and Drug Administration. (2007). Guidance for Industry Computerized Systems Used in Clinical Investigations. Retrieved from http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070266.pdf Food and Drug Administration. (2013). Guidance for Industry Electronic Source Data Capture in Clinical Investigations. Retrieved from http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf Food and Drug Administration. (2003). Guidance for Industry Part 11, Electronic Records; Electronic Signatures – Scope and Application. Retrieved from http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm