DocuSign is a vendor supported application that meets 21 CFR Part 11. The following White paper addresses this from a system validation and change control process. Click here
Additionally, validation reports from the vendor are received monthly and can be accessed by contacting OCR directly.
Recommended tool for studies under an IND or IDE
- HIPAA and Part 11 compliant validated
- Can be used seamlessly for patients or LAR
- Facilitates in person or telemedicine/ phone visit and documents consent process
- Can be uploaded directly into PennChart
- Usability for other trial documentation – DOA, etc.
Cost associated with use
Training and Resources
- Manual Using DocuSign to Obtain eConsent
- Training Guide Using DocuSign to Obtain eConsent
- Using DocuSign to Sign eConsent Tip sheet
- Information from Docusign on Part 11 Compliance
Online training required. Please submit an access request form and ticket to the helpdesk if you are interested in using the application.