FDA Part 11 Compliance Assurances

FDA Part 11 Compliance Assurances

UCSF has a version of DocuSign and REDCap Premium that are compliant with the FDA’s regulation at 21 CFR Part 11 for electronic signatures (commonly referred to as “Part 11”). If you are conducting an FDA-regulated study and you are utilizing either of these electronic platforms to collect research signatures, the study sponsor may ask for assurances that the platforms are Part 11 compliant. The documents on this page can be provided to study sponsors when such requests are made.

UCSF Electronic Signature Certificate/Non-Repudiation Statement and Letter

For information on electronic signature certification and non-repudiation, please visit the Office of Ethics and Compliance (OEC) page on Part 11 Compliance: Electronic Signatures in Human Subjects Research.

HRPP Memos

Memos may be provided to research sponsors to document the UCSF Human Research Protection Program’s guidance on the use of electronic consent and HIPAA authorization signatures during the COVID-19 public health emergency.