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Part 11 DocuSign Available for FDA-Regulated Studies

FDA-regulated research study teams are now able to use a special DocuSign platform to obtain electronic signatures. This platform has special identity verification and authentication processes to meet FDA requirements, and it may only be used for adult consent and for certain FDA documents and forms.

Learn more about this free resource and how to request elevated access at https://ts.vcu.edu/askit/university-resources/docusign/fda-part-11-getting-started/

Studies that are not FDA-regulated should continue to use the regular DocuSign platform to obtain electronic signatures. 

As always, minimal risk studies also have the option to request a waiver of the consent signature, and a Waiver of Consent Documentation Log template (for documenting verbal consent) is available in the Study Conduct Toolkit at https://research.vcu.edu/human_research/guidance.htm

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