Research & Clinical Trial Consent
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Research & Clinical Trial Consent
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The Research & Clinical Trial Consent Form provides the comprehensive informed consent documentation required for human subjects research. It covers the essential elements mandated by the Common Rule (45 CFR 46), FDA regulations (21 CFR 50), and Institutional Review Board (IRB) requirements: study purpose and procedures, risks and benefits, alternatives, confidentiality protections, compensation details, and the right to withdraw.
The form uses a structured format that presents complex research information in an accessible way. The study description section explains the research question, what participation involves, the expected duration and number of visits, and any experimental procedures or interventions. Risks are presented with clear categorization by likelihood and severity, alongside potential benefits to the participant and to science.
Data use and privacy sections detail how participant data will be collected, stored, de-identified, and shared, including any biobanking or future use provisions. The voluntary participation section emphasizes that declining or withdrawing from the study will not affect the participant's standard medical care. This template can be customized for drug trials, device studies, observational research, and survey-based studies.
What's included
- Participant identification with date of birth
- Study description and procedure explanation
- Study ID and protocol number tracking
- Principal investigator identification
- Expected participation duration
- Emergency contact information
- Research consent agreement with e-signature
- Right to withdraw acknowledgment
- Data privacy and confidentiality protections
- Compensation and reimbursement details
- Dual signatures (participant and investigator)
Who uses this template
- Clinical research sites and academic medical centers
- Pharmaceutical company-sponsored trials
- Medical device studies
- University-based research programs
All form fields
12 fields across 3 pages. Customize any field after signing up.
How to use the Research & Clinical Trial Consent
Getting started with this template takes just a few minutes. Sign up for a free Formisoft trial, then select the Research & Clinical Trial Consent from the template library. The form is ready to use immediately, but you can customize every field, add your practice logo, and adjust the layout to match your workflow.
Setup steps
- 1Choose the template. Find the Research & Clinical Trial Consent in the template library and click “Use this template” to add it to your account.
- 2Customize fields. Add, remove, or reorder any of the 12 fields. Set fields as required or optional based on your practice needs.
- 3Brand it. Upload your logo, pick your colors, and add a custom welcome message so patients see your practice identity.
- 4Share with patients. Send the form via SMS, email, or embed it on your website. Patients complete it on any device before their visit.
- 5Review submissions. Responses appear in your dashboard in real time. Patient records are created automatically from the data collected.
Frequently asked questions
Is the Research & Clinical Trial Consent HIPAA compliant?
Yes. All Formisoft templates, including the Research & Clinical Trial Consent, are HIPAA compliant. Data is encrypted with 256-bit AES at rest and TLS 1.3 in transit. A Business Associate Agreement (BAA) is included on every plan.
Can I customize the fields in this template?
Absolutely. You can add, remove, reorder, or modify any of the 12 fields. You can also add conditional logic, new pages, file uploads, e-signatures, and payment fields.
How do patients fill out this form?
Patients receive a link via SMS, email, or QR code. They complete the form on their phone, tablet, or computer before their appointment. No app download required.
Can I send this form automatically before appointments?
Yes. Formisoft's workflow automation can send intake forms automatically when an appointment is booked. You can set the timing (e.g., 48 hours before the visit) and include reminders for patients who haven't completed it.
Does this template work on mobile devices?
Yes. The Research & Clinical Trial Consent is fully responsive and works on any device. Most patients complete intake forms on their phone, so every template is optimized for mobile-first use.
Start with this template
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