Clinical Study Agreements are essential documents used when initiating medical research involving human subjects in the United States. These agreements formalize the relationship between research sponsors, institutions, and investigators while ensuring compliance with FDA regulations, IRB requirements, and other applicable laws. A Clinical Study Agreement typically includes detailed provisions for protocol implementation, subject safety, data management, financial terms, and intellectual property rights. It serves as the primary contractual framework for conducting clinical trials and is crucial for protecting all parties' interests while advancing medical research.
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1. Parties: Identifies all parties to the agreement, including sponsor, institution, and principal investigator
2. Background: Outlines the purpose of the clinical study and context of the agreement
3. Definitions: Defines key terms used throughout the agreement including Study, Protocol, Study Data, Confidential Information, etc.
4. Scope of Work: Details the clinical study requirements, protocol adherence, and responsibilities of each party
5. Compliance: Requirements for regulatory compliance, IRB approval, and applicable laws including FDA regulations and human subject protection
6. Payment Terms: Payment schedule, amounts, and conditions for payment including study budget details
7. Confidentiality: Provisions for protecting confidential information and data privacy requirements
8. Intellectual Property: Rights and ownership of study data, inventions, and publications
9. Term and Termination: Duration of agreement and conditions for termination or early study closure
10. Indemnification: Liability and indemnification obligations of parties including insurance requirements
1. Publication Rights: Terms for publishing study results and academic rights for institutions
2. Equipment Provision: Terms for equipment provided for study purposes including maintenance and return
3. Subject Injury: Provisions for handling and compensation of research-related injuries
4. Multi-Center Provisions: Specific terms for multi-center studies including coordination and data sharing
5. Biological Samples: Handling, storage, and ownership of biological samples collected during the study
1. Schedule A - Protocol: Detailed clinical study protocol including methodology and procedures
2. Schedule B - Budget: Detailed study budget breakdown and payment schedule
3. Schedule C - Payment Schedule: Timeline and conditions for payments including milestone payments
4. Schedule D - Form FDA 1572: Statement of investigator form and related regulatory documentation
5. Schedule E - Financial Disclosure Forms: Required investigator financial disclosure documentation
6. Schedule F - Insurance Certificates: Proof of required insurance coverage for all parties
7. Schedule G - Data Privacy Terms: Detailed data protection and privacy requirements including HIPAA compliance
8. Schedule H - Quality Requirements: Specific quality assurance and control requirements for the study
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