Healthcare Template
Free Clinical Trial Agreement Template
A clinical trial agreement documents informed consent for research participation.
Template
Copy this markdown, replace the {{variables}}, and send via API.
# Clinical Trial Participation Agreement
**Participant:** {{participantName}}
**Institution:** {{institutionName}}
**Study:** {{studyTitle}}
**Date:** {{date}}
## Purpose
{{studyPurpose}}
## Procedures
{{procedures}}
## Risks
{{risks}}
## Benefits
{{potentialBenefits}}
## Compensation
{{compensation}}
## Voluntary Participation
Participation is voluntary. I may withdraw at any time.Send for e-signature
curl -X POST https://signb.ee/api/send \
-H "Authorization: Bearer YOUR_API_KEY" \
-H "Content-Type: application/json" \
-d '{
"content": "YOUR_RENDERED_MARKDOWN",
"senderName": "Your Name",
"senderEmail": "you@company.com",
"recipientName": "Recipient",
"recipientEmail": "recipient@email.com"
}'What happens next
- Signbee converts the markdown to a professional PDF
- Recipient gets an email with a signing link
- Both parties sign with an animated handwriting signature
- Both receive the signed PDF with a SHA-256 certificate
All signatures are legally binding under the ESIGN Act, eIDAS, and ECA.
More details
Clinical trial consent is the most heavily regulated form of informed consent in healthcare. It's governed by federal regulations (21 CFR 50 in the US), the Declaration of Helsinki internationally, and Institutional Review Board (IRB) or Ethics Committee approval requirements.
Why clinical trial consent is different from standard medical consent: Research involves unknown risks. Unlike standard medical procedures with established risk profiles, clinical trials are investigating new treatments where the full risk profile is not yet known. The consent process must be more thorough, more documented, and more protective of participant autonomy.
Required elements under 21 CFR 50.25: 1. Purpose — Why the research is being conducted and what it hopes to discover. 2. Procedures — Exactly what the participant will undergo, including randomisation, placebo controls, and blinding. 3. Duration — Expected length of participation and number of visits. 4. Risks — Known risks, reasonably foreseeable risks, and the fact that unknown risks may exist. 5. Benefits — Potential benefits to the participant and/or to science. Do not overstate personal benefits. 6. Alternatives — Other treatments available outside the trial. 7. Confidentiality — How research data will be protected, who has access, and whether results may be published (with de-identification). 8. Compensation and costs — Payment for participation, reimbursement of expenses, and whether the participant bears any treatment costs. 9. Injury provisions — What happens if the participant is injured during the trial. Who pays for treatment? Is there compensation for injury? 10. Voluntary participation — Participation is entirely voluntary. The participant can withdraw at any time without penalty and without affecting their standard care. 11. Contact information — Who to contact with questions about the research, participant rights, and research-related injuries.
Special populations: Additional protections exist for children, pregnant women, prisoners, and cognitively impaired individuals. These groups require additional IRB review and may require both participant assent and legally authorised representative consent.
Frequently asked questions
Can you withdraw from a clinical trial at any time?
Yes. Participation in clinical trials is entirely voluntary. You can withdraw at any time for any reason without penalty and without affecting your standard medical care. The consent form must clearly state this right.
Who reviews clinical trial consent forms?
An Institutional Review Board (IRB) or Ethics Committee must review and approve all clinical trial consent forms before the study begins. The IRB ensures the consent process adequately protects participant rights, safety, and welfare.
Can clinical trial consent be given electronically?
Yes, under FDA guidance on electronic informed consent (eConsent). Electronic consent can include multimedia elements (videos, interactive content) and must meet the same regulatory requirements as paper consent. The FDA encourages eConsent as it may improve participant understanding.
Related resources
Send this template for signing — free, no credit card.