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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