Yale Docusign 21 CFR Part 11
Yale Docusign 21 CFR Part 11 eSignature application
Important
The validated Yale Docusign 21 CFR Part 11 application is intended only for activities that require electronic signatures in the execution of FDA-regulated research at Yale University.
It is the responsibility of the Yale document sender to ensure they are using the correct Docusign account (standard University Docusign vs. Yale Docusign 21 CFR Part 11) before sending documents for review or signature. Any document sent through the standard University Docusign account, which should have been sent via the Yale Docusign 21 CFR Part 11, will not be considered Part 11 compliant.
The cost of using Docusign Part 11 ($6.77/envelope) will be charged to the associated research projects. When envelopes are routed for signature in Docusign, the sender will be required to provide the IRB/HIC number which will be used for project billing. Users should consult with the project finance team to verify that Docusign can be used for their study.
If you require access to the standard Docusign application (non- Part 11), you can get more information and request access using the following link: https://yale.service-now.com/it_legacy?id=service_offering&sys_id=f5f828aa1b5138107286759d1e4bcb9e.
Application Overview
The Yale Docusign 21 CFR Part 11 application is a restricted version of Docusign intended exclusively for health-related human subjects research at Yale that involves electronic signatures on documents supporting FDA-regulated studies.
To send documents for electronic signature or to create, edit, and send document templates within the Yale Docusign 21 CFR Part 11 environment, you must complete Yale Docusign 21 CFR Part 11 User Training.
Note: Individuals who only sign documents using Docusign Part 11 do not require training.
Trained users with appropriate access credentials may:
- Send Docusign envelopes for signatures, with secure user authentication required.
- Use enforced signature workflows to ensure proper signing order.
- Access audit trail reports for full traceability of document actions including reason for signing.
- Retain the document either electronically or in printed form, stored on a validated or access-controlled system, in compliance with applicable retention periods and project requirements.
Docusign Access & Training
To obtain access to the Yale Docusign 21 CFR Part 11 application:
- Click on the “Docusign Part 11 Access Request” link on this page and complete/submit the form.
- Once your access request has been submitted, an automated email will be sent to the manager listed on your access request form for approval.
- After your manager approves your request, you will receive an email with the link to complete the required training.
- After completing the required training, upload the training certificate to your Access Request via the email link that you received in step 3.
- After your training certificate has been received and approved by the support team, you will receive a confirmation email from the support team. You will also receive an account activation email from the Docusign application. Click on the ‘Activate’ link to finish your account activation.
Note: If you don't click the activation link within 30 days, you will need to contact Docusign support team at 21cfrpt11Docusign@yale.edu to obtain a new activation link.
How do I know if my study requires Docusign P11?
The Yale 21 CFR Part 11 instance of Docusign should only be used for electronic signatures for documents that relate to FDA-regulated studies. This instance of Docusign has been approved for signing eConsents for FDA-regulated studies as long as eConsent has been approved by the Institutional Review Board (IRB) of record for that particular study.
HRPP has provided guidance to help you determine whether your project requires Part 11 Compliance. Use this decision tree to help determine whether you must comply with Part 11 for data capture systems and e-consent: https://yalesurvey.ca1.qualtrics.com/jfe/form/SV_3lntIMyfM3msczI.
Guidance/ Reference Documents
21 CFR Part 11 – Electronic Records: Electronic Signatures, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-informed-consent-clinical-investigations-questions-and-answers
Yale Human Research Protection Program Investigator Manual, https://your.yale.edu/research-support/human-research-protection-program/policies-procedures-guidance-and-related-3
Yale HRPP Part 11 Compliance & Applicability to Human Subjects Research, https://your.yale.edu/sites/default/files/files/ResearchSupport/Part_11-Guidance_FINAL_20250331.pdf
Yale HRPP Guidance for Using eConsent in the Conduct of Human Subjects Research https://your.yale.edu/sites/default/files/files/ResearchSupport/eConsent%20Guidance_FINAL_20250331.pdf
Note: Documentation demonstrating Yale Docusign 21 CFR Part 11 validation can be requested to: 21cfrpt11Docusign@yale.edu.