This Working Group sought 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. The group developed and disseminated 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 sought 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. The group developed and disseminated 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.
Meeting Archive
This group met regularly to work towards achieving the goals of the CTSA Program. For questions, please contact support@ccos.ctsa.io.
