Clinical Agreement Template for India

1. Third Party Obligations: Required when external vendors or contractors are involved in the trial

2. Equipment and Materials: Needed when specific equipment or materials are provided by sponsor

3. Publication Rights: Include when addressing rights to publish trial results

4. Biological Samples: Required when trial involves collection and storage of biological samples

5. Multi-Center Trial Provisions: Include for trials conducted across multiple sites

6. Study Drug Supply: Required when trial involves drug supply and management

7. Quality Assurance: Detailed quality control measures, needed for complex trials

8. Site Staff Requirements: Include when specific staffing requirements need to be detailed

9. Subject Recruitment: Required when specific recruitment targets or methods need to be defined

10. Force Majeure: Include specific provisions for pandemic or other extraordinary circumstances

1. Schedule 1 - Trial Protocol: Detailed clinical trial protocol and methodology

2. Schedule 2 - Budget and Payment Schedule: Detailed breakdown of costs and payment milestones

3. Schedule 3 - Timeline and Milestones: Project timeline, key milestones, and deliverables

4. Schedule 4 - Required Documentation: List of essential documents and regulatory filings

5. Schedule 5 - Data Management Plan: Detailed procedures for data handling and management

6. Schedule 6 - Safety Reporting Procedures: Procedures for adverse event reporting and safety monitoring

7. Schedule 7 - Quality Management Plan: Quality assurance and control procedures

8. Appendix A - Required Forms: Standard forms and templates for trial documentation

9. Appendix B - Key Personnel: List of key staff and their responsibilities

10. Appendix C - Insurance Certificates: Copies of required insurance documentation