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ADDRESS CHANGE: The VUMC IRB and HRPP have moved locations. The office address is:

Vanderbilt University Medical Center Institutional Review Board

2525 West End Avenue Suite 600

Nashville, TN 37203-8820

This information may need to be revised on study documents (such as 1572) or provided to study sponsors.
 

Reminder Regarding Electronic Systems and Signatures: VUMC researchers participating in FDA-regulated studies that involve electronic records must maintain compliance with 21 CFR Part 11 (Part 11). The FDA requires Part 11 compliance for FDA-regulated clinical research to ensure that electronic records and signatures are as reliable as paper records and handwritten signatures. Study activities requiring Part 11 validation include eConsent transactions, electronic document management, and study data collection, management, and archival.

 If you are using REDCap, Part 11 compliance applies to both the REDCap system and the individual project setup.  Investigators requiring Part 11 should review their project configurations for compliance.

In the last year, VUMC REDCap has released REDCap Central, a cloud-based, fully compliant Part 11 environment.   As of March 1, 2025, VUMC is requiring that all newly submitted FDA-regulated studies that plan to use REDCap for electronic records to use REDCap Central. REDCap Central is designed to provide a comprehensive compliance framework, ensuring that all regulatory requirements are met. There is a cost associated with REDCap Central. If you have any questions about whether your project setup aligns with Part 11 requirements or about the costs associated with REDCap Central, please contact REDCapCentral@vumc.org.