Developing an e-consent system

Developing an e-consent system
K. Burke, N. Grover, L. Zhang, N. Amdeeb, E. Liu, A. Sapozhnikova
Clinical Trials, 2021; 18(supplement 5) pp 87-88
With the COVID-19 pandemic, the ability to coordinate and manage research studies remotely has become increasingly important. Most systems offer a variation of a mobile interface for study participants to complete self-administered questionnaires outside of the clinical setting. However, there was a need for functionality to allow a potential participant to virtually and electronically complete a screening questionnaire and provide consent. The web development team and research staff at the George Washington University Biostatistics Center collaborated to create a web-based public form and electronic informed consent system. This system allows potential participants to be screened and join studies without the need to be physically present to sign regulatory documents. The e-consent system is based on the Biostatistics Center’s existing electronic patient report outcome system. Users are able to access the system on a variety of devices, as the display is tailored to the size of the screen. To assure data quality and security, the system incorporates reCAPTCHA verification, email verification, tailored in-system messaging, personal links and codes, link expiration, electronic signature, and encryption. Existing features from the electronically patient report outcome system-such as skip patterns, range checks, lookup tables, and partial saving-were utilized to minimize data quality issues. In describing the design, implementation, successes, and challenges of this system, the Biostatistics Center team hopes to inform other coordinating centers and research studies interested in utilizing virtual enrollment systems for remote research.

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