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.
Group Goals
Design and implement a process for rapid 21 CFR Part 11 software validation for REDCap.
Produce Part 11 validation documentation within 4 weeks for every 6-month release of REDCap.
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.
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.
Contact Information
For more information or to join this Working Group, please contact the CCOS coordinator.
