Inspiration

Hundreds of thousands of volunteers are sought to register for clinical trials to test for a vaccine to COVID-19. Oracle developed a cloud service called the COVID-19 Prevention Trials Network (CoVPN) Volunteer Screening Registry. This service is designed to allow people to volunteer for clinical trials, and assists clinical trial sites to choose participants based on trial-defined demographics. The issue is the application is web-based and doesn't utilize the sensors on a mobile device.

Title 45 CFR § 46.117 requires informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject's legally authorized representative. A written copy shall be given to the person signing the informed consent form.

This can be accomplished using the DocuSign eSignature API combined with Apple ResearchKit framework.

What it does

The registry is a platform for collecting basic information for screening for being invited to a clinical trial. A PDF copy of informed consent form stating that the elements of informed consent required can be easily completed and retained for records. After consent is obtained, ResearchKit framework permits the collection of data from the mobile device.

How we built it

Followign DocuSign iOS SDK and integrating ResearchKit

Starting with the Docusign, the investigator can read the consent form or send it to the volunteer. Or the individual can sign on their own.

Challenges we ran into were around implementing security features. The intent was to add ID verification, however, we soon learned that requires a separate server instance instead of adjusting the attributes or access to the document.

Accomplishments that we're proud of is combining both frameworks. DocuSign has its challenges and the goal was to determine a concept that can actually be published.

What we learned is there are quite a few capabilities of the DocuSign eSignature API and we understand how it works using the additional features such as ID Verification.

What's next for CORSVP™ is to create the server to permit integration and usage with ID Verfication.

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