DocuSign is a 21 CFR Part 11 compliant electronic signature tool that can be used to enable remote signatures on research consent forms.
- 21 CFR Part 11 compliant (required for all FDA-regulated research of greater than minimal risk)
- Configuration of reusable consent form templates
- Use of access codes for patient signature ensures that remote consenting does not skip the consent conversation
- Supports various signature roles (e.g., Patient Viewer, Patient Signer, Consenter, Physician, LAR, etc.) with both serial and parallel signatures
- Completed consent can be downloaded by both the study team and the patient
- Single Sign-On (coming soon)
For more information, contact the JH DocuSign team at ResearchDocuSign@jh.edu.