DocuSign
DocuSign is a digital signing software used to send documents online and collect electronic signatures remotely. Senders are able to upload documents to an electronic envelope, add fields for signature and date, and send the envelope to a specified recipient via email.
There are two versions of DocuSign available for clinical research teams, DocuSign eSignature and DocuSign Part 11. DocuSign Part 11 is 21 CFR Part 11 compliant. You may need to request access to one or both versions depending on how you will use this software.
DocuSign eSignature and DocuSign Part 11 accounts are HIPPA compliant.
Important
- Highly secure information should not be placed in the subject title or message of the DocuSign envelope.
- DocuSign is not a document repository. Signed documents must be saved on a department shared drive per your department policy/procedure.
- The license and associated terms of use for the UVA Academic side’s implementation of DocuSign do not permit its use for clinical operations, except for administrative tasks within the School of Medicine, including Clinical Research, which are permitted.
DocuSign eSignature Account
DocuSign eSignature can be used to sign any research document except when obtaining eConsent for an FDA-regulated study. You’ll need to request access to the Research eSignature account if you’re a sender-the person creating, sending, and managing envelopes. You do not need to request access if you are a signer, a person that only needs to sign documents.
For added security, UVA requires those of you sending eConsents to add an access code for research subjects.
| Who needs access? | When to use DocuSign eSignature |
|---|---|
| Sender-The person creating, sending, and managing envelopes | To complete a delegation of authority (DOA) log To complete a protocol training log To complete a Form FDA 1572 To complete a Statement of Investigator To obtain eConsent for studies not regulated by the FDA |
DocuSign Part 11 Account
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 to the research Part 11 account if you are a sender-the person creating, sending, and managing envelopes AND if you’re a signer- a person that only needs to sign documents.
For added security, UVA 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 creating, sending, and managing envelopes Signer-The person signing envelopes | To obtain eConsent of a 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, etc, required by study sponsor |
DocuSign Login
Once you are given access to a DocuSign account, you will get an activation email from DocuSign.
Always log in to DocuSign using the following link: https://account.docusign.com/#/username.
Log in using your uvacomputingID@virginia.edu email address then click the blue “USE COMPANY LOGIN” button to be directed to Netbadge. You should never create a separate password for DocuSign.
DocuSign Tip Sheets
Tip sheet: How to add an access code for a research subject (DocuSign eSignature & DocuSign Part 11)
Tip sheet: Selecting the correct DocuSign account (DocuSign eSignature & DocuSign Part 11)
DocuSign Training and Support
Visit the DocuSign Support Center for training and support.
Need Additional Help?
Email our office if you have questions about how to use DocuSign for research purposes.