Clinical Trial Participation Consent Form

Clinical Trial Participation Consent Form Template

Clinical research is the backbone of medical advancement, but protecting participant rights and ensuring informed consent is paramount. This Clinical Trial Participation Consent Form template helps research institutions, hospitals, and pharmaceutical companies streamline the enrollment process while maintaining the highest ethical and legal standards.

Designed for Healthcare Research Teams

Whether you're a clinical research coordinator, principal investigator, or IRB administrator, this template creates a clear, compliant pathway for enrolling participants in clinical trials. It covers everything from study protocols and potential side effects to compensation details and withdrawal rights—ensuring participants understand exactly what they're agreeing to.

The form collects essential participant information, medical history relevant to the study, emergency contacts, and explicit consent for each aspect of the trial. By using conditional logic, you can tailor questions based on study phase, risk level, or participant demographics, making the consent process more efficient without sacrificing thoroughness.

Streamline Consent Management with Paperform

Built on Paperform, this template transforms the traditionally cumbersome consent process into a modern, accessible experience. Participants can review and complete consent documentation on any device, and research teams can track submissions in real time. The professional, branded design helps build trust with potential participants while maintaining the clinical precision required for IRB approval.

Enhance your workflow with Papersign to collect legally binding electronic signatures on consent documents, creating a complete audit trail that satisfies regulatory requirements. Each signature is timestamped and securely stored, giving you peace of mind for compliance reviews.

Automate your research operations with Stepper to route completed consents to your research database, notify study coordinators when new participants enroll, update CRM records, and trigger follow-up scheduling—all without manual data entry. Connect your clinical trial management system, REDCap, or other research tools to keep your entire study workflow synchronized.

This template is ideal for Phase I-IV clinical trials, observational studies, vaccine trials, and medical device research across hospitals, academic medical centers, contract research organizations (CROs), and pharmaceutical companies. It's designed to meet HIPAA requirements and can be customized to align with specific IRB protocols and institutional policies.

Start enrolling participants with confidence, knowing your consent process protects both their rights and your research integrity.