Clinical Trial Agreement Generator

What is a Clinical Trial Agreement?

A Clinical Trial Agreement is a contract between a sponsor (typically a pharmaceutical or medical device company) and a research institution or investigator that outlines the terms and conditions for conducting a clinical study. This agreement establishes expectations regarding study protocol, patient recruitment, data collection, regulatory compliance, confidentiality, intellectual property rights, publication rights, and compensation for conducting the trial.

Key Sections Typically Included:

• Study Protocol and Compliance Requirements
• Investigator Responsibilities
• Subject Recruitment and Informed Consent
• Budget and Payment Schedule
• Regulatory Compliance (FDA, IRB, etc.)
• Data Collection and Reporting
• Adverse Event Reporting
• Study Drug/Device Management
• Confidentiality Provisions
• Intellectual Property Rights
• Publication Rights and Review Process
• Subject Injury Provisions
• Indemnification and Insurance
• Study Monitoring and Audits
• Study Termination Conditions
• Record Retention Requirements

Why Use Our Generator?

Our Clinical Trial Agreement generator helps sponsors and research institutions create a comprehensive document that clearly establishes the parameters for conducting compliant and ethical clinical research. By defining regulatory responsibilities, data rights, and compensation structures upfront, all parties can focus on advancing medical knowledge while protecting patient safety and research integrity.

Frequently Asked Questions

• Q: How should intellectual property and publication rights be balanced?

  • A: The agreement should clearly distinguish between background IP (owned before the trial) and foreground IP (developed during the trial), establish ownership rights for inventions arising from the study, and address licensing rights for commercialization of discoveries. It should balance the sponsor's interest in protecting proprietary information with investigators' academic freedom to publish results, specify publication review periods and processes, and outline conditions under which publication might be delayed (patent filing) or restricted (confidential information). The agreement should also address rights to use study data for regulatory submissions, specify ownership of biological samples and derived data, and establish provisions for secondary analyses of study data.

• Q: What budget and payment terms should be included?

  • A: The agreement should provide a detailed budget breakdown by cost category (patient visits, procedures, administrative costs), establish payment schedules linked to enrollment milestones and data submission, and specify invoicing procedures and payment timelines. It should address handling of screen failures, early withdrawals, and protocol deviations, outline provisions for budget amendments if protocol changes occur, and establish record-keeping requirements for financial documentation. The agreement should also address costs for additional services outside the core protocol, specify whether payments cover indirect costs and overhead, and outline conditions under which payments might be withheld or adjusted.

• Q: How should regulatory compliance and monitoring be addressed?

  • A: The agreement should clearly allocate responsibility for obtaining and maintaining required approvals (IRB/Ethics Committee, FDA, etc.), establish compliance with Good Clinical Practice (GCP) standards and applicable regulations, and specify record-keeping requirements for regulatory documentation. It should outline monitoring and audit procedures including frequency and scope, establish protocols for reporting and addressing protocol deviations, and specify responsibilities for adverse event reporting to regulatory authorities. The agreement should also address procedures for implementing protocol amendments, outline requirements for maintaining trial master files, and establish compliance with subject privacy regulations (HIPAA, GDPR, etc.).