DocuSign

About

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

Consider these before choosing:

• Application is HIPAA and Part 11 compliant validated 
• Can be used seamlessly for patients or Legally Authorized Representative (LAR). 
• Facilitates in person or telemedicine/ phone visit and documents consent process.
• Can be uploaded directly into PennChart 
• Usability for other trial documentation such as Delegation of Authority (DOA).

• There is cost associated with using Docusign.

Access  

• DocuSign-acf

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.

To Submit a Ticket to the PennChart Team click here.