Adobe Sign Validated to be 21 CFR Part 11 Compliant for E-Signatures
Adobe Sign Validated to be 21 CFR Part 11 Compliant for E-Signatures Heading link
Adobe Sign is validated to be compliant with 21 CFR Part 11 when using the approved procedures, enabling UIC researchers to obtain electronic signatures on all research records required for FDA-regulated research. This includes the use of Adobe Sign for the purpose of obtaining written consent signatures from research participants.
Researchers needing access to send documents using Adobe Sign, first need to request that access (see How to Get Started). Once access is granted and in order to meet FDA standards documents must be sent using this link. There the user will upload their document(s), enter the email address(es) of the signer(s), place the signature field(s), and send it out for signature(s). By using that link, all of the necessary configuration settings are activated to collect the signatures in compliance with 21 CFR Part 11.
Please note that Adobe Sign is not approved for PHI (Protected Health Information), but is expected to be in the future.
Adobe Sign is also not intended for long-term storage of documents. Consent forms and other materials signed via Adobe Sign must be downloaded and saved in an appropriate platform.
For additional information regarding electronic signatures, please refer to the University of Illinois System website.