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1. Subject Recruitment: Include when the institution is responsible for recruitment activities

2. Equipment and Supplies: Include when specific equipment or supplies are provided by the sponsor

3. Biological Samples: Include when the trial involves collection and handling of biological materials

4. Sub-contractor Provisions: Include when third-party service providers are involved

5. Publication Rights: Include when academic institutions require publication rights

6. Post-Trial Access: Include when continued access to study drug after trial completion is relevant

7. Local Community Benefits: Include when required by local ethics committees or institutional policies

1. Schedule 1 - Study Protocol: Detailed clinical trial protocol and any amendments

2. Schedule 2 - Budget and Payment Schedule: Detailed breakdown of costs, payment terms, and invoicing procedures

3. Schedule 3 - Timeline and Milestones: Detailed study schedule and key performance indicators

4. Schedule 4 - Required Documentation: List of essential documents, forms, and reporting templates

5. Schedule 5 - Safety Reporting Procedures: Detailed procedures for adverse event reporting

6. Schedule 6 - Personnel and Facilities: Details of key study personnel and facility requirements

7. Appendix A - Insurance Certificates: Copies of required insurance documentation

8. Appendix B - Regulatory Approvals: Copies of FDA and ethics committee approvals

9. Appendix C - Data Protection Protocol: Detailed procedures for handling personal data and maintaining privacy