This is a question the JAF team is often asked, simply put: REDCap should be validated to improve data quality, ensure 21 CFR Part 11 Compliance, and maintain data integrity. JAF has extensive experience reducing risk, while strengthening REDCap processes for institutional organizations and teams. Clinical trial data is subject to FDA Good Clinical Practices (GCP) regulations, which may have an impact on patient safety and product quality. The regulatory referenced guidelines mentioned below are not intended to be all-encompassing, but a selection that the agency considers in its approval of clinical studies performed under its regulations. “FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application, August 2003

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, May 2007
FDA Guidance for Industry: Electronic Source Documentation in Clinical Investigations, September 2013
FDA Information Sheet: Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors, July 2014
Use of Electronic Informed Consent Questions and Answers, Guidance for Institutional Review Boards, Investigators, and Sponsors, December 2016

In addition to complying with these guidelines, REDCap ensures that there is consistency, accuracy, reliability, availability, and security of clinical data.

You can find more information on why REDCap should be validated and how the JAF Team can help your organization achieve compliance by visiting our REDCap Validation page or sending an email to

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