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1. CRO Obligations: Required when a Contract Research Organization is involved in managing the study

2. Multi-site Coordination: Needed for studies conducted across multiple research sites

3. Equipment and Materials: Required when sponsor provides specific equipment or materials

4. Translation Requirements: Needed when study materials require translation to local languages

5. Biological Samples: Required when study involves collection and handling of biological samples

6. Post-Study Access: Needed when continued access to study treatment is provided after study completion

7. Local Community Benefits: Required for studies with specific commitments to local community development

8. Technology Transfer: Needed when agreement includes technology transfer components

1. Schedule 1 - Study Protocol: Detailed protocol including study design, methodology, and procedures

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

3. Schedule 3 - Timeline and Milestones: Detailed project timeline with key deliverables and deadlines

4. Schedule 4 - Personnel and Responsibilities: List of key personnel and their roles in the study

5. Schedule 5 - Required Documents and Approvals: List of regulatory documents and approvals needed

6. Schedule 6 - Safety Reporting Procedures: Procedures for reporting and handling adverse events

7. Schedule 7 - Data Management Plan: Details of data collection, storage, and handling procedures

8. Schedule 8 - Quality Assurance Requirements: Quality control and monitoring procedures

9. Appendix A - Insurance Certificates: Copies of required insurance policies

10. Appendix B - Ethics Committee Approval: Copy of ethics committee approval and related correspondence