DocuSign

Need access to DocuSign?

Complete the DocuSign Request Form.

Request Access

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.

 

 Our DocuSign eSignature and DocuSign Part 11 accounts are HIPPA compliant.

Need access to DocuSign?

Complete the DocuSign Request Form.

Request Access
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 envelopesTo 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 the DocuSign Research account, you will get an activation email from DocuSign, please IGNORE IT! You do not need to activate your account.

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
DocuSign Training and Support

Visit the DocuSign Support Center for training and support.

Need Additional Help?

Email our office

uvaclinicaltrials@virginia.edu