The REDCap Core maintains a 21 Part 11 compliant REDCap server. This server has dedicated procedures, testing, and documentation to maintain 21 Part 11 server-level compliance. However, to be fully compliant with 21 Part 11, the study team is required to maintain project-level compliance. This means:
- The PI and/or study team must specify in the REDCap new project request if 21 Part 11 Compliance is required so that the project is created on the validated server.
- The PI and/or study team is required to create and maintain documentation of how the REDCap project will be setup and used for 21 Part 11. At minimum, this includes:
- A Project Specification Plan: This detailed document will cover the configuration, instruments, events, modules and user roles in the REDCap project. This should be created before moving to Production, but should be updated if there are Production changes.
- A Project Testing Plan: This document details how the project was tested prior to production to ensure that all aspects (notifications, automated invitations, branching logic, data quality checks) were performing correctly.
- A User Management and Role Log: Nearly identical to the IRB staffing log, it also includes the role, or permissions and privileges each user will have in REDCap.
- A Production History Log: This log supplements the REDCap audit logs, providing information about post-Production changes, why they were made, and IRB amendments involved in the changes for the duration of the project.
- The PI is responsible for ensuring that all study team members have received appropriate training for their role on a 21 Part 11 project.
As part of the project creation process, please plan to meet with the REDCap team to discuss these requirements. Sample documents and a user manual are available. You can sign up for a time here: