This version of DocuSign at VCU should be limited to study documents that relate to FDA-regulated studies.  This version of DocuSign can also be used for eConsent as long as eConsent has been approved by the Institutional Review Board (IRB) of record for that particular study.  Documents signed in this system should be downloaded from the system, in addition to the generated audit trail, and should be stored in the study’s respective binder in accordance with state, federal and university record retention requirements.

Account provisioning is done by the Office of the Vice President for Research and Innovation (OVPRI).  To gain access to the system, please complete the required DocuSign Part 11 training.

Once training has been completed, OVPRI will create an account for this version of DocuSign and will send an email once complete.

Please note that there are no custom permission sets on the Part 11 system. Therefore, there is no option for senders to be able to create templates under Part 11.

Steps to switch accounts when in the standard VCU DocuSign account (this is the default DocuSign for all university employees):

1. Click your initials in the top right-hand corner of your screen
2. Click Switch Account (NOTE: if you were logged into DocuSign when your Part 11 account was created, you may not see the Switch Account option. You may need to completely log out of DocuSign and log back in before the session will recognize that you have a Part 11 account as well.)
3. Click “VCU CFR part 11” and then confirm

Steps to change default account to DocuSign part 11:

1. While in the part 11 account, click your initials in the top right-hand corner of your screen
2. Click my preferences
3. In general settings, click “set as default” in your default eSignature account section

DocuSign Part 11 Policy and Procedures

• Account provisioning:

OVPRI research IT: erahelp@vcu.edu

• Signer or sender-related issues:

Central IT DocuSign group: docusign@vcu.edu

Please ensure that you have also completed standard VCU DocuSign training.

• Policy/procedure or questions on system use:

Lauren Wallace, MS, RAC-Drugs
Director of Clinical Research Regulatory Affairs
kanigherl@vcu.edu

Record Retention

DocuSign is an electronic signature solution and not intended as a long-term storage solution for University records.  A copy of completed documents will reside in DocuSign no longer than 18 months.  It is the sender's responsibility to ensure the official/public record is archived in a long-term storage solution, retained and destroyed in accordance with the VCU Records Management policy and time periods listed in the Library of Virginia’s Retention and Disposition Schedules.

For a list of applications approved for long-term storage, please visit Technology Services Where Can I Store My Data? page.