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

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Design and implement a process for rapid 21 CFR Part 11 software validation for REDCap.
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Produce Part 11 validation documentation within 4 weeks for every 6-month release of REDCap.
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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. 


 

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21 CFR Part 11 Compliance for REDCap - 03/17/2025

Monday, March 17, 2025

02:00 PM - 03:00 PM EDT

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21 CFR Part 11 Compliance for REDCap - 03/17/2025

Monday, March 17, 2025

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 more information or to join this Working Group, please contact the CCOS coordinator.

Sarah Erskine
Sarah Erskine

CCOS Meeting Coordinator

Contact Information

For more information or to join this Working Group, please contact the CCOS coordinator.

Sarah Erskine
Sarah Erskine

CCOS Meeting Coordinator