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)
Once the completed questionnaire is received, the DocuSign team will provide the study team with instructions for modifying the consent form and submitting a Change in Research to the IRB. When the Change in Research is approved, the DocuSign team will schedule training for the study team. All study team members who will use DocuSign MUST attend training. After training is complete, the DocuSign team will set up DocuSign user accounts for the study team which will allow the study team to set their consent up and begin obtaining signed consents via DocuSign.
For more information, contact the JH DocuSign team at firstname.lastname@example.org.