Adobe Acrobat Sign for 21 CFR Part 11 Compliance
Adobe Acrobat Sign for 21 CFR Part 11 Compliance
Adobe Acrobat Sign is a digital signing software used to send documents online and collect electronic signatures remotely.
Features
Adobe Acrobat Sign, also know as Acrobat Sign, is a digital signing software for FDA-regulated clinical research studies that require eConsent and other documents requiring 21 CFR Part 11 compliance. The Office of Research IT has validated Adobe Acrobat Sign to be compliant with 21 CFR Part 11 when using the approved procedures, enabling UR researchers to obtain electronic signatures on all research records required for FDA-regulated research. Adobe Acrobat Sign is the only University-approved 21 CFR Part 11 and HIPAA compliant eSignature solution available for clinical research teams.
Note: For Non-CFR Part 11 signing needs, please contact the UR Tech Store.
When to use Adobe Acrobat Sign Part 11
Adobe Acrobat Sign for 21 CFR Part 11 Compliance should ONLY be used:
- To obtain eConsent for a 21 CFR Part 11 FDA regulated trial.
- To obtain eConsent for a non-FDA regulated trial where 21 CFR Part 11 compliance is required by study sponsor.
- For 21 CFR Part 11 compliant signatures on a Delegation of Authority Log (DOA), protocol training log, or other study documents required by the study sponsor.
| Adobe Acrobat Sign | Part 11 (Access: ORIT) | Non Part 11 (Access: Tech Store) |
|---|---|---|
| e-Consent | ORIT builds View cost information | N/A (Use REDCap) |
| Non e-Consent (other study related documents) | User builds View cost information | User builds |
| Non study related documents | N/A | User builds |
Get Started
Researchers needing access to send and/or sign Part 11 compliant documents using Adobe Acrobat Sign must:
- Utilizing Adobe Acrobat Sign for 21 CFR Part 11 compliant eSignatures must be described in the study protocol and approved by the IRB.
- Complete mandatory training in MyPath: Adobe Acrobat Sign for 21 CFR Part 11 Compliance (2024).
- Request Adobe Acrobat Sign account from Office of Research IT.
- You will be added to a group within Adobe Acrobat Sign based on your study and/or signing needs.
- For eConsent: Submit a request to the Office of Research IT to have your eConsent workflow built in Adobe Acrobat Sign.
- eConsent build or modifications are typically completed within two weeks.
- Please do not submit request until the final consent/assent form(s) are approved by the IRB.
Cost
Study teams should plan for their eConsent/eSignature needs for 21 CFR Part 11 as part of their grant submissions. A $1,000 budget for yearly eConsent/eSignature needs should be planned.
Resources
Please review the following SOPs specific to the use of 21 CFR Part 11 compliant Adobe Acrobat Sign at UR:
- ADOBE-SIGN-SOP-01: Management of Electronic Signatures Using Adobe Acrobat Sign
- SIGN-ESIG-WIN-01: Use of Adobe Acrobat Sign for the Application of Electronic Signatures
For general tutorials on Adobe Acrobat Sign, visit Acrobat Sign Learn & Support.
Contact
For 21 CFR Part 11 eConsent/eSignatures, please contact the Office of Research IT.
For non 21 CFR Part 11 eSignatures, please contact the UR Tech Store.
Frequently Asked Questions
About Adobe Acrobat Sign for 21 CFR Part 11 Compliance
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.
- 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.
Login and Access
Please complete this Request for Access via Service Now. If you have any issues, please contact the Office of Research IT. As part of your access you will be assigned to a group associated with your research study or sending needs. For example, if a study team wishes to use Acrobat Sign for eConsent, ORIT will set up a group in Acrobat Sign for that study group (named with the IRB number). Any eConsent workflows that are set up for that study will be available to only the members of that group.
Depending on your needs you may be associated with more than one group. When sending a document for signature you will need to send from the group that contains the templates, workflows, or documents that need to be sent.
Yes, please complete this Request for Access via Service Now. If you have any issues, please contact the Office of Research IT.
Please complete this Request for Access via Service Now. If you have any issues, please contact the Office of Research IT.
Please contact the UR Tech Store for Acrobat Sign needs not requiring 21 CFR Part 11 compliance.
Please complete this Request for Access via Service Now. If you have any issues, please contact the Office of Research IT.
Budgeting & Costs
Study teams should plan for their eConsent/eSignature needs for CFR Part 11 as part of their grant submissions. A $1,000 budget for yearly e-Signature needs should be planned.
Acrobat Sign for eConsent
Please complete the Request Acrobat Sign eConsent Setup or Modification.
The Office of Research IT will contact you if there are any questions regarding your request. eConsent setup or modifications are typically completed within two weeks but may take longer if IRB revisions are needed. Please do not submit request until the final consent/assent form(s) are approved by the IRB.
Acrobat Sign for Other Research Related Documents
Yes. Office of Research IT must build all eConsent forms, but study related documents may be built by the study team. Please review SIGN-ESIG-WIN-01: Use of Adobe Acrobat Sign for the Application of Electronic Signatures.
Access & Storage
Within Acrobat Sign only the person sending the document as well as the signers of the document can access the completed signed document.
Yes. The cc option is available as part of sending an eConsent form with Acrobat Sign. The person who is cc’ed will receive an email notification when the document signatures are completed which contains a link to the signed document. They can then login to Acrobat Sign and download the document.
It is recommended that study teams download and print out the signed agreement along with the audit report and store in the study binder. For study management activities study teams may download a copy of the signed agreement and store in REDCap (not Part 11 compliant) or Box (not Part 11 compliant) so that those on the study team who need access to the agreement have it. The original signed agreement would remain in Acrobat Sign and be used in case of audit.
Administrators with the Privacy role enabled can access signed documents to either download or delete (if needed for GDPR). This currently includes members of the Office of Research IT team. If needed, study teams should contact the Office of Research IT.
Additional Help
Please review the following SOPs specific to the use of 21 CFR Part 11 compliant Acrobat Sign at UR:
- ADOBE-SIGN-SOP-01: Management of Electronic Signatures Using Adobe Acrobat Sign
- SIGN-ESIG-WIN-01: Use of Adobe Acrobat Sign for the Application of Electronic Signatures
For general tutorials on Adobe Acrobat Sign, visit Acrobat Sign Learn & Support.
Please contact the Office of Research IT.