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1. Sub-contracting: Include when certain services will be delegated to third parties

2. Multi-center Provisions: Include for studies conducted across multiple research sites

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

4. Biological Samples: Include when study involves collection and storage of biological samples

5. Safety Reporting: Include detailed safety reporting procedures for high-risk studies

6. Publication Rights: Include detailed publication procedures when academic institutions are involved

7. Phase-Specific Requirements: Include specific provisions based on the clinical trial phase

8. Audit and Inspection Rights: Include enhanced audit provisions for complex or high-risk studies

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

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

3. Schedule 3 - Timeline: Study timeline including key milestones and deliverables

4. Schedule 4 - Personnel and Responsibilities: List of key personnel and their roles/responsibilities

5. Schedule 5 - Required Reports: Format and timing of required study reports

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

7. Schedule 7 - Quality Requirements: Quality assurance and control procedures

8. Schedule 8 - Form of Informed Consent: Template informed consent forms and patient information sheets