UW REDCap Part 11
Ensure your FDA-regulated research meets regulatory standards with UW’s validated REDCap Part 11 instance. Secure, compliant, and designed to support electronic records and signatures in accordance with FDA 21 CFR Part 11 requirements.
Trusted for FDA-Regulated Research Leverage a HIPAA-compliant, AWS-hosted REDCap environment jointly managed by UW Research IT and UW Medicine ITS, tailored for FDA compliance.
UW REDCap Part 11 (FDA 21 CFR Part 11)
This guidance applies to FDA-regulated research where any of the following apply:
Electronic records are used to meet any FDA regulatory record‑keeping requirement—i.e., when required records are created, modified, maintained, archived, retrieved, or transmitted in electronic form. Electronic signatures are used in place of required handwritten signatures, including signatures on informed consent documentation and required clinical documentation.
DISCLAIMER: This information is provided as guidance for the University of Washington (UW) research community and applies only to the UW Research IT (RIT) managed 21 CFR Part 11 REDCap instance. This information does not constitute regulatory or legal advice. Responsibility for FDA 21 CFR Part 11 compliance ultimately resides with the clinical investigation team and Principal Investigator (PI).
REDCap (Research Electronic Data Capture) is a secure, HIPAA-compliant, web-based application designed by researchers for research data capture and management. It supports customizable forms and surveys, granular user permissions, and robust data export options compatible with major analysis tools.
The UW Part 11 REDCap instance is hosted on Amazon Web Services (AWS) and jointly managed by UW Research IT (RIT) and UW Medicine ITS. It is configured and maintained to support FDA-regulated research when used in accordance with established institutional procedures.
FDA 21 CFR Part 11 Overview
This guidance applies to FDA-regulated research that uses electronic records to meet FDA record-keeping requirements or electronic signatures in place of required handwritten signatures. The system requires: System-Level controls (RIT Responsibility)
Validated REDCap Environment
Controlled updates and testing
Security controls and audit trails
Infrastructure documentation
Important: Using REDCap alone does not automatically make a project 21 CFR Part 11 compliant; both system and project-level activities must be met and maintained throughout the project lifecycle. The project PI is responsible for ensuring that both the above requirements are met throughout the life of their study.
Study/Project Level controls (PI & Study Team Responsibility)
Documented procedures and SOPs
User training
Project specific trainings, this is outside of the training provided by RIT.
Project-specific validation
Project validation is the process by which the project team verifies, during each upgrade and before study launch, that all project components (e.g., date calculations, email triggers) function as intended, without routine support from the REDCap team.
E-Consent in Part 11 REDCap
FDA-regulated studies using electronic consent in REDCap must adhere to Part 11 requirements for electronic signatures and consent documentation.
This typically includes:
Use of the REDCap electronic consent Framework
Electronic consent templates
Documented identity verification, version control, and attestation procedures
Training & Support Resources
Required Training
Translational Research Education Engine (TREE): An interactive learning environment offering dedicated FDA Part 11 REDCap training modules.
Support Services
Advanced Part 11 consultations, project validation support, and documentation guidance available on a fee-for-service basis through UW Research IT (RIT).
Service & Payment Structure
To support Part 11 validated projects, UW Research IT (RIT) applies a quarterly service fee:
$2,000 per quarter (with a UW worktag)
UW Internal Studies
$2,700 per quarter (without a UW worktag).
Studies External to UW
Note: custom development, advanced consultation; overuse of AWS resources, or extended support beyond standard Part 11 services may also incur additional fees. Consult with redcap-part11help@uw.edu prior to commencing your project for an estimate.
This Fee Supports:
Oversight and administrative support necessary to maintain the Part 11 validated environment
System administration
Compliance review
Project validation support
Secure storage and audit tracking consistent with Part 11 practices.
Why Is There a Charge for the Part 11 REDCap Instance?
The UW REDCap Part 11 enabled instance supports FDA-regulated research and requires a significantly higher level of technical oversight, documentation, and administrative support than the standard REDCap service. The aforementioned charge model reflects the additional infrastructure and compliance activities necessary to maintain a validated environment consistent with FDA 21 CFR Part 11 expectations.
Part 11 projects require ongoing system validation, enhanced security controls, audit trail maintenance, and detailed documentation to support regulatory inspections.
The quarterly fee helps support:
Validated system maintenance
Including controlled updates, testing, and documentation required to preserve Part 11 compliance
Enhanced security and access controls
including audit logging and user accountability
Dedicated support expertise
for FDA-regulated workflows that exceed standard REDCap service levels
Administrative review and oversight
of Part 11 project requests, documentation, and production moves