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1. Material Transfer: Required when biological materials or compounds need to be transferred between parties

2. Equipment Provision: Needed when sponsor provides specific equipment for the trial

3. Third Party Contractors: Include when CROs or other contractors are involved in trial management

4. Multi-Center Trial Provisions: Required for trials conducted at multiple research sites

5. Pharmacovigilance: Detailed section needed for drug trials requiring specific adverse event reporting

6. Archive Provisions: Specific requirements for long-term data storage beyond standard retention

7. Technology Transfer: Needed when specific technical knowledge or software must be transferred

8. Specimen Banking: Required when biological specimens will be stored for future use

1. Schedule 1 - Protocol: Detailed clinical trial protocol including all amendments

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

3. Schedule 3 - Timeline and Milestones: Detailed project schedule including recruitment targets and deadlines

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

5. Schedule 5 - Material Transfer Terms: Specific conditions for handling and transfer of trial materials

6. Schedule 6 - Data Management Plan: Detailed procedures for data collection, storage, and handling

7. Appendix A - Form of Informed Consent: Approved patient information and consent forms

8. Appendix B - Insurance Certificates: Copies of required insurance documentation

9. Appendix C - Quality Assurance Requirements: Detailed quality control and monitoring procedures

10. Appendix D - Safety Reporting Procedures: Specific procedures for adverse event reporting and safety monitoring