Clinical Trial Participant Records Request Form

Streamline Clinical Trial Records Requests with Paperform

Managing clinical trial participant records requires precision, compliance, and secure documentation. This Clinical Trial Participant Records Request Form template helps research institutions, pharmaceutical companies, contract research organizations (CROs), and healthcare providers handle records requests efficiently while maintaining regulatory compliance.

Whether you're responding to sponsor requests, regulatory audits, IRB inquiries, or legitimate research needs, this form captures all essential information including study protocol numbers, IRB approval documentation, participant consent verification, and data anonymization preferences.

Built for Research Compliance and Data Integrity

Clinical research operates under strict regulatory frameworks including FDA guidelines, ICH-GCP standards, and HIPAA requirements. This template ensures you collect the necessary authorization, study identifiers, and data handling preferences upfront—reducing back-and-forth communication and ensuring requests meet compliance standards from the start.

The form guides requestors through providing their credentials, specifying exactly which records they need, confirming proper authorization, and selecting appropriate data protection measures. Conditional logic reveals relevant fields based on request type and anonymization requirements.

Automate Workflows with Stepper Integration

Beyond capturing the request, you can use Stepper to automate your entire records request workflow. Route requests to the appropriate research coordinator or data manager based on study protocol, trigger IRB notification for sensitive data requests, create secure document folders, send status updates to requestors, and maintain an audit trail—all without manual intervention.

For requests requiring formal agreements, integrate Papersign to send Data Use Agreements or Material Transfer Agreements for eSignature before releasing records, ensuring legal protection and regulatory compliance.

Designed for Research Organizations

This template is ideal for clinical trial coordinators, research data managers, regulatory affairs specialists, and clinical research associates at academic medical centers, pharmaceutical companies, biotech firms, and CROs. The professional layout maintains the serious, compliant tone required for clinical research while remaining user-friendly for both internal teams and external requestors.

Paperform's SOC 2 Type II compliance, data residency controls, and robust security features make it a trusted choice for organizations handling sensitive research data. Start with this template and customize fields to match your institution's specific protocols and compliance requirements.