FDA Part 11 Compliance Assurances

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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.

Note: For information about how to determine whether you need an FDA compliant signature platform, how to decide which platform is the best fit for your study, and where to access more information about the platforms, please see FAQ #2 (“How can I obtain signed consent electronically?”) on the IRB COVID-19 FAQ & Resources page.

UCSF Electronic Signature Certificate Statement and Non-Repudiation Statement

This statement from UCSF Chief Ethics and Compliance Officer Brian Smith, JD, MBA may be provided to sponsors if requested: Statement on University of California, San Francisco Compliance with 21 CFR Part 11 and (5/20/21). Note: This also includes a statement on Non-Repudiation of Electronic Signatures in the DocuSign Part 11 Module and the REDCap Premium Software Platform (5/18/21).

HRPP Memos

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

Current memo: April 2021 Update on Electronic Consent Signatures Memo

Earlier memos are available for reference as needed: 5/28/2020 Memo and 9/29/2020 Memo