When to use Adobe Acrobat Sign Part 11

Adobe Acrobat Sign 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 this service from Office of Research IT if you are a sender of documents for electronic signature, or eConsent.

For added security, URMC requires those of you sending eConsents to add a method of authentication for research subjects. 

When to use Adobe Acrobat Sign Part 11

• To obtain eConsent for an FDA regulated trial.
• To obtain eConsent for a non-FDA regulated trial where 21 CFR Part 11 compliance is required by study sponsor.
• For Part 11 compliant signatures on a DOA, protocol training log, or other documents required by the study sponsor.