Food and Drug Administration’s 21 CFR Part 11 requires a REDCap project to have certain features enabled as well as extensive documentation by the study team in order to meet the requirements. The following are brief description of the minimal requirements for FDA projects that the study team will need to establish in order for the project to comply with FDA 21 CFR Part 11 requirements in addition to REDCap system being validated.
REDCap project settings recommended to be enabled
Record Locking with Electronic Signature
Require a reason when making changes in existing records
Project documentation recommended to be created by study team
It is recommended the study team create a Project Standard Operating Procedure which should include the following documents at the minimal:
Project Validation Test Scripts
Project Validation Plan and Change Control
Data Management Plan
Downtime Process
Role and Responsibilities
Users Training Procedure