Enabling international studies with secure consent eSignature

Background

Science 37 is a research and technology company that specializes in decentralized clinical trials. Due to the remote nature of our sites, our Participants, Participant Representatives, and Study Staff must sign legal documents digitally.

Problem

In order for Science 37 to conduct trials in the European Union, we needed to comply with strict requirements for digital signatures and identity verification for eConsent. These requirements differ from the United States and led to an integration with Adobe Sign.

To enable compliance with these requirements, we needed to ensure our designs integrated Adobe Sign across the entire signature collection process—from the internal study build process through the signing experience for Participants, Participant Representatives, and Study Staff.

*The configure step enables more secure signature type*

*The build step allows data managers to create eConsent form*

*The preview step allows them to see various device experiences*

I worked directly with internal Data Designers to understand the eConsent process and get feedback on my designs. The new feature impacted three areas within the eConsent build:

Configure: Flagging a form to use the more secure Adobe Sign signature field, translating a form, and assigning role access to specific fields (for example: only a participant can sign here)
Build: Adding site-specific content to the form
Preview: Allowing the data designer to view the final PDF in Adobe Sign

*eConsent form is available 2 weeks prior to consent visit*

*All fields are disabled in form preview*

Once the form is built and applied to a Visit Plan for an active study, it will be available within the Participant mobile application. Participants and Participant Representatives can interact with an eConsent in the following ways:

Understand: Preview or download the form before it is available to sign for further review with family, caregivers, etc.
Sign: Once the form is available to sign, the Participant or Participant Rep can launch the Adobe Sign experience within the mobile app and complete the document
Review: After all parties have signed the document, it will be available to view or download

*Once the eConsent visit has started, the form is available to sign*

*Adobe Sign opens in frame overlaid on app for seamless experience*

*Once signed, the form can be submitted*

Impact

Implementing an integration with Adobe Sign enabled Science 37 to conduct trials across the European Union, such as an innovative Type 2 Diabetes study in Denmark that collected data via wearable medical devices.

return to all work