FDA Projects
Food and Drug Administrationās 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 is a 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 the 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
Questions?