Clinical Research Study Participant Data Consent Form

Clinical Research Study Participant Data Consent Form

Conducting clinical research requires clear, compliant documentation of participant consent for data collection and processing. This Clinical Research Study Participant Data Consent Form template provides clinical research coordinators and study teams with a structured, professional solution for obtaining informed consent from study participants.

Built for Clinical Research Workflows

This form template addresses the complete spectrum of data consent needs in clinical trials, from initial screening through long-term follow-up. Research coordinators can collect explicit consent for screening data collection, randomization assignment, protocol adherence monitoring, adverse event documentation, and ongoing contact for follow-up assessments.

The form is structured to meet regulatory requirements while remaining clear and accessible to participants. Each consent element is presented transparently, allowing participants to understand exactly how their data will be collected, processed, stored, and used throughout the study lifecycle.

Key Features for Research Teams

Clinical research coordinators will appreciate the comprehensive approach to consent documentation. The form captures essential participant information, details the specific types of data processing, and records explicit consent for each study component. This ensures your research team maintains thorough documentation that satisfies institutional review board (IRB) requirements and regulatory compliance standards.

The form includes sections for emergency contact authorization, data sharing preferences, and withdrawal rights—critical elements that protect both participants and research institutions. Built-in conditional logic ensures participants see only relevant questions based on their responses, creating a smoother experience while maintaining thorough documentation.

Streamline Research Administration with Paperform

Paperform's platform is ideal for clinical research coordination. The form builder's document-style editor makes it easy to present complex consent information in a clear, readable format. You can embed institutional logos, add explanatory text between consent sections, and format the form to match your research institution's branding guidelines.

For research teams managing multiple studies, Paperform's submission management features help you track consent status across participants. Integrate with your clinical trial management system (CTMS) or export data to research databases. Use Papersign (papersign.com) to capture legally binding electronic signatures on consent documents, creating a complete audit trail for regulatory compliance.

Automate follow-up workflows with Stepper (stepper.io)—send confirmation emails to participants, notify study coordinators of new enrollments, update participant databases, and trigger onboarding sequences for newly consented participants. This automation reduces administrative burden while ensuring no participant falls through the cracks.

Trusted by Healthcare and Research Professionals

With SOC 2 Type II compliance and robust security features, Paperform provides the data protection standards that clinical research demands. While not HIPAA compliant, Paperform offers the security infrastructure needed for most research data collection scenarios outside of protected health information (PHI) management.

Whether you're coordinating Phase I-IV clinical trials, observational studies, or registry research, this consent form template provides the foundation for compliant, participant-centered data collection that supports rigorous clinical research.