U.S Department of Health & Human ServicesHHSNational Institutes of HealthNIHNCATSNCATSCTSA ProgramCTSA
CTSA CCOS

Coordination, Communication, and Operations Support

RegisterLog In
Home
Working Groups
Need Help

21 CFR Part 11 Compliance for REDCap

Overview

This Working Group seeks to aid CTSA sites in achieving and maintaining 21 CFR Part 11 compliance for electronic records in clinical research, primarily those records collected through REDCap. We will develop and disseminate an implementation guide that provides clarity about the validation requirements and process for institutions to adopt.  

21 CFR Part 11 Compliance for REDCap

Overview

This Working Group seeks to aid CTSA sites in achieving and maintaining 21 CFR Part 11 compliance for electronic records in clinical research, primarily those records collected through REDCap. We will develop and disseminate an implementation guide that provides clarity about the validation requirements and process for institutions to adopt.  

21 CFR Part 11 Compliance for REDCap

Group Goals

placeholder
Design and implement a process for rapid 21 CFR Part 11 software validation for REDCap.
placeholder
Produce Part 11 validation documentation within 4 weeks for every 6-month release of REDCap.
placeholder
Produce a SOP template to aid institutions in documentation of study processes for Part 11 compliance.

Upcoming Meetings

This group meets on the third Monday of every month from 2:00-3:00 p.m. ET. To stay updated on these meetings, including agendas, presenters, and meeting minutes, please visit the link below. 


 

Archive
placeholder
21 CFR Part 11 Compliance for REDCap - 6/17/2024

Monday, June 17, 2024

02:00 PM - 03:00 PM EDT

View Calendar
placeholder
21 CFR Part 11 Compliance for REDCap - 6/17/2024

Monday, June 17, 2024

02:00 PM - 03:00 PM EDT

Upcoming Meetings

This group meets on the third Monday of every month from 2:00-3:00 p.m. ET. To stay updated on these meetings, including agendas, presenters, and meeting minutes, please visit the link below. 


 

Contact Information

For questions or more information about this Working Group, please contact the CCOS coordinator. 

Sarah Erskine
Sarah Erskine

CCOS Meeting Coordinator

Contact

Contact Information

For questions or more information about this Working Group, please contact the CCOS coordinator. 

Sarah Erskine
Sarah Erskine

CCOS Meeting Coordinator

Coordination, Communication, and Operations Support (CCOS) is funded by theNational Center for Advancing Translational Sciences, National Institutes of Health.

HomeContact UsPrivacy PolicyAccessibility Statement
Freedom of Information (FOIA)Office of Inspector General (OIG)Cookie Preference
twitter iconlinkedin icon