Docusign - 21 CFR Part 11
DocuSign eSignature is a digital signing software used to send documents online and collect electronic signatures remotely. DocuSign Part 11 is 21 CFR Part 11 and HIPAA compliant and is available for clinical 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.
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DocuSign eSignature is available for use at the UR. However, DocuSign eSignature is not 21 CFR Part 11 compliant
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There is separate DocuSign Part 11 account for sending envelopes that require 21 CFR Part 11 compliance.
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You must request a DocuSign Part 11 account (coming soon!). Once it's set up, you will need to toggle between your regular UR DocuSign eSignature account and the UR DocuSign Part 11 account.
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DocuSign is not intended to be used as a document management system.
DocuSign Part 11 Account Information
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. You’ll need to request access (Coming soon!) to the research DocuSign Part 11 account if you are a sender of documents for electronic signature, or eConsent AND if you’re a signer, a person that only needs to sign documents.
For added security, URMC requires those of you sending eConsents to add an access code for research subjects.
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Who needs access?
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When to use DocuSign Part 11?
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To obtain eConsent of an FDA regulated trial
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To obtain eConsent of a non-FDA regulated trial required by study sponsor
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For Part 11 compliant signatures on a DOA, protocol training log, or other documents required by the study sponsor
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Once you are given access to the DocuSign Part 11 account, you will get an activation email from DocuSign. Please activate your account.
Log in to DocuSign using the following link: https://account.docusign.com/
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