Grappling with the inadequacies of the existing paper-based consent process — magnified when patients are children — prompted ATHN to look for a better solution. This success story shares the development journey of DFconsent, an eConsent solution that informs and engages.
DFconsent: An eConsent Solution that Informs and Engages
DFconsent is an integrated electronic informed consent (eConsent) application, developed with the core mission of providing a valid, 21 CFR 11-compliant, electronic informed consent process that:
- Facilitates clinical trials,
- Is participant-friendly and easy to navigate, and
- Integrates with DFdiscover and other EDC platforms.
The Timing Was Perfect
The DFconsent solution hit the market at just the right time. Development of the application began in 2017, in partnership with the American Thrombosis and Hemostasis Network (ATHN), which wanted to reconstruct its informed consent process with the twin goals of better informing patients and replacing one of the last paper-based forms they were using.
Then, beginning in early 2020, the COVID-19 pandemic exponentially accelerated the paradigm shift to increasingly digital management of clinical trials. Sponsors and sites were and are looking for better ways to facilitate informed consent without requiring face-to-face contact between study participants and study staff.