Standard informed consent for interventional clinical trials. Includes all FDA-required elements per 21 CFR 50.25 with sections for purpose, procedures, risks, benefits, and participant rights.
This Basic Clinical Trial consent template provides a comprehensive foundation for interventional research studies. It covers all elements required by FDA regulations under 21 CFR 50.25 for informed consent in clinical trials.
The template includes ten standard sections covering introduction, study purpose, procedures, risks, benefits, alternatives, confidentiality, compensation, voluntary participation, and contact information. Each section contains placeholder text that researchers can customize for their specific study.
Designed for phase 2-4 drug trials, device studies, and other interventional research, this template ensures you meet regulatory requirements while maintaining readability for participants. The language balances legal precision with accessibility, helping participants make truly informed decisions about their involvement.
This template is suitable for single-site or multi-site studies and can be adapted for various therapeutic areas including oncology, cardiology, neurology, and rare diseases.
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
This template includes all elements required by 21 CFR 50.25 for FDA-regulated clinical trials.