Office of Clinical Research

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
• Benefits
  • 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
• Forms
  • DocuSign ACF
  • 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.

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• Recommended for all studies that are NOT under an IND/IDE
• Benefits
  • HIPAA compliant for e-signatures
  • Easy self-service workflows- upload the consent and manage sending to subjects
  • Subject signs and document accessible by research team for additional signature
• Need team to have active REDCap and PMACS accounts
• There is no cost associated with use of the application

Contact REDCap user support if you are interested in using redcap@mail.med.upenn.edu or the main OCR inbox for more information.

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• Recommended for studies involving PennMedicine patients with active MPM and where documentation of consent is waived
• Benefits
  • Consent form can be uploaded into MPM and directed to patient
  • Direct messaging back and forth with the patient
  • Can provide consent and then engage in survey or other MPM directed activities
• No advisable for LAR consents 
• There is no cost associated but your study does need to be built in PennChart,
• Contact OCR or the MPM PennChart research team if you are interested in using
• Epic/PennChart Consents
  • No advisable for LAR consents
  • There is no cost associated but your study does need to be built in PennChart
  • Contact OCR or the MPM PennChart Research team if you are interested in using
  • Epic/ Pennchart Consents
  • Consents functionality built with PennChart
  • HIPAA compliant/ lives within the patient EMR
  • Need study built in PennChart and patient associated to the study
  • Utilizes tablet or other hospital device

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Recommended for studies where the population and study lend itself to smartphone application use

Benefits:

• This is a DIY web-based, research study app builder that requires no
• programming.
• HIPAA compliant
• Participants download the app and use it to sign consent, and send automatically back to the study team
• App specifications are built through a web interface. Apps created are compatible for both iOS and Android and can be added to the Google and Apple app store within a very short time frame.
• The vendor company, TrialX, has an existing BAA with Penn Medicine, removing the need for research teams and departments to have their own vendors vetted through IS.
• Subsidized, sliding- scale prices making this a cost effective option for research teams.

To request a demo, contact the Office of Clinical Research at psom-ocrops@pobox.upenn.edu

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