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DocuSign - FDA Part 11 Getting Started

Updated 

Summary

DocuSign Part 11 accounts are separate from the standard VCU DocuSign domain accounts. The DocuSign Part 11 domain account is compliant with federal regulation 21 CFR 11. Systems that comply with 21 CFR 11 are configured under certain specifications to ensure that the electronic records and electronic signatures executed in the system are equivalent to a handwritten signature on paper. These systems comply with specific validation standards to ensure that they meet the requirements of 21 CFR 11.

Environment

DocuSign eSignature Part 11 domain

Solution

To be provided with a DocuSign Part 11 account, please:

  1. Complete the required DocuSign Part 11 training (note that all individuals using DocuSign--whether under the Part 11 or the standard DocuSign account--are expected to have completed all foundational DocuSign training)
  2. Thoroughly review the DocuSign Part 11 Policy and Procedures document
  3. Ensure that you have read and understood the issues with Adobe Acrobat-specific features in PDFs uploaded to DocuSign

Additional Information

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

NOTE: 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.

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.

Access to Part 11

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 your account for this version of DocuSign and will send you an email.

Steps to switch between the standard DocuSign account and the Part 11 account

  1. Click your initials/profile icon 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 the appropriate account to which you wish to switch and then confirm

Support Contacts

Account provisioning:
OVPRI research IT: erahelp@vcu.edu

Signer or sender-related issues:
Central IT DocuSign group: docusign@vcu.edu

Please remember that envelopes sent to VCUHS members must be addressed to their eid@vcu.edu email address, not to the vcuhealth.org email address. 

Policy/procedure or questions on system use:
Lauren Wallace, MS, RAC-Drugs
Director of Clinical Research Regulatory Affairs
kanigherl@vcu.edu

 

Keywords: DocuSign FDA eSignature CFR
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