Comprehensive informed consent for ePRO and patient-reported outcome studies. Designed for digital enrollment with electronic signature provisions and mobile app usage.
The Study Enrollment Consent for ePRO template is specifically designed for digital data collection studies using electronic patient-reported outcomes. It addresses the unique considerations of mobile app usage, electronic signatures, and ongoing digital engagement throughout the study.
With fourteen comprehensive sections, this template covers introduction, study purpose, participant role, timeline and procedures, electronic devices and mobile app usage, risks, benefits, alternatives, confidentiality and data security, electronic consent and signatures, compensation and costs, voluntary participation, future contact provisions, and complete contact information.
The technology section explains what devices are required, how the app works, data transmission security, and what happens if participants experience technical difficulties. This transparency helps participants understand exactly what their digital engagement will involve.
This template meets requirements for electronic consent under FDA guidance while maintaining a participant-friendly format suitable for self-enrollment on mobile devices.
This is a preview of the complete consent form experience participants will see.
Please provide your contact details
Please confirm you understand the following
Please sign below using your mouse or finger
Signature Area
Participants draw their signature here