Collaborative compliance: A consortium-based framework for achieving 21 CFR part 11 readiness in REDCap across CTSA...

Area of Science:

• Regulatory Science
• Health Informatics
• Translational Science

Background:

• Academic institutions face challenges meeting U.S. FDA 21 CFR Part 11 requirements for electronic records and signatures in REDCap.
• Lack of clear guidance hinders compliance, increasing reliance on external vendors.

Purpose of the Study:

• To develop and disseminate an implementation guide for REDCap users to achieve 21 CFR Part 11 compliance.
• To foster collaboration among institutions to improve regulatory adherence.

Main Methods:

• A working group from the National Center for Advancing Translational Sciences (NCATS) developed the guide.
• The guide was released to academic research institutions.

Main Results:

• The guide was accessed by 259 individuals from 164 institutions within six months.
• Users reported reduced vendor reliance, enhanced documentation, and successful implementation of Part 11-ready REDCap systems.

Conclusions:

• Collaborative efforts between technical and regulatory experts can effectively improve regulatory compliance.
• The NCATS-developed guide facilitates Part 11 compliance for REDCap users, enhancing the research enterprise.