The Clinical Study Agreement is essential for any organization conducting clinical trials in India, serving as the primary contractual framework between sponsors, research institutions, and investigators. This document is required under Indian law, specifically the Drugs and Clinical Trials Rules, 2019, and must comply with ICMR guidelines and other applicable regulations. It defines the parameters for conducting clinical research, including protocol implementation, subject protection, data handling, financial terms, and regulatory compliance. The agreement is particularly crucial given India's strict regulatory environment for clinical trials and specific requirements for subject protection, adverse event reporting, and compensation for trial-related injuries. It should be used whenever a clinical trial is to be conducted in India, whether by pharmaceutical companies, research organizations, or academic institutions.
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1. Parties: Identification of all contracting parties including Sponsor, Institution, Principal Investigator
2. Background: Context of the clinical study, brief description of the investigational product, and purpose of the agreement
3. Definitions: Detailed definitions of terms used throughout the agreement
4. Scope of Work: Description of the clinical study, responsibilities of each party, and compliance requirements
5. Regulatory Compliance: Obligations regarding regulatory approvals, ethics committee approval, and compliance with applicable laws
6. Study Conduct: Protocol adherence, subject recruitment, informed consent, and study procedures
7. Safety Reporting: Adverse event reporting, safety monitoring, and related procedures
8. Data Management: Data collection, recording, storage, protection, and sharing requirements
9. Confidentiality: Protection of confidential information, duration of obligations, and exceptions
10. Intellectual Property: Ownership of study data, inventions, and publications
11. Financial Arrangements: Payment terms, schedule, and conditions for payment
12. Insurance and Indemnification: Insurance requirements, liability allocation, and indemnification provisions
13. Term and Termination: Duration of agreement, termination rights, and post-termination obligations
14. General Provisions: Standard legal provisions including governing law, dispute resolution, and notices
1. Equipment and Supplies: Required when sponsor provides specific equipment or supplies for the study
2. Third Party Agreements: Needed when additional parties (CROs, labs) are involved in study conduct
3. Study Drug Management: Required for drug trials, covering storage, handling, and accountability
4. Biological Samples: Needed when study involves collection and handling of biological samples
5. Publication Rights: Detailed publication procedures when academic institutions are involved
6. Subject Injury Compensation: Detailed compensation procedures for trial-related injuries as per Indian regulations
7. Translation Requirements: When study documents need to be available in local languages
8. Quality Assurance: Specific quality control and monitoring requirements beyond standard provisions
1. Schedule 1 - Protocol: Full clinical trial protocol or protocol summary
2. Schedule 2 - Budget and Payment Schedule: Detailed study budget, payment terms, and invoicing procedures
3. Schedule 3 - Team Members and Contact Information: List of key study personnel and their contact details
4. Schedule 4 - Division of Responsibilities: Detailed matrix of responsibilities between sponsor, institution, and investigator
5. Schedule 5 - Required Documentation: List of essential documents required for study conduct and compliance
6. Schedule 6 - Insurance Certificates: Copies of required insurance policies and certificates
7. Appendix A - Confidentiality Agreement: Detailed confidentiality terms for study team members
8. Appendix B - Quality Requirements: Specific quality assurance and control requirements
9. Appendix C - Data Protection Requirements: Detailed data protection and privacy procedures
10. Appendix D - Safety Reporting Procedures: Detailed procedures for adverse event reporting and safety monitoring
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