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.
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When to use DocuSign Part 11? |
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Requirements for a UR DocuSign Part 11 Account:
Please be sure you have met all of the requirements necessary for a UR DocuSign Part 11 account. These requirements are listed below.
- The UR DocuSign Part 11 MyPath training must be completed for your new permission profile (DS Viewer or DS Sender) before an account can be provided or updated. Click here to access this training.
- UR DocuSign Part 11 accounts will only be provided to users with a URMC Active Directory account. External users will need to acquire a URMC Guest Account; click here for more information.
If you have any further questions, please email docusign_admin@urmc.rochester.edu.