DocuSign Part 11 is 21 CFR Part 11 and HIPAA compliant and is available for research teams at the University of Rochester. Senders can upload documents to an electronic envelope, add fields for signature and date, and send the envelope to a specified recipient via email.

DocuSign Part 11 should ONLY be used when obtaining eConsent for an FDA-regulated study or if a sponsor says you need to use it to sign documents for your specific study.

DocuSign is not intended to be used as a document management system.

For added security, URMC requires those of you sending eConsents to add an access code for research subjects.

Who needs access?

When to use DocuSign Part 11?

  • Sender - the person sending documents for electronic signature

  • Signer - the person signing envelopes

  • To obtain eConsent of an FDA regulated trial

  • To obtain eConsent of a non-FDA regulated trial required by study sponsor

  • For Part 11 compliant signatures on a DOA, protocol training log, or other documents required by the study sponsor

Once you are given access to the DocuSign Part 11 account, you will get an activation email from DocuSign. Please activate your account.

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