¶¶Òõ¶ÌÊÓƵ

1. Staff and Sub-investigators: Used when the investigator will be working with a team or delegates

2. Equipment and Supplies: Include when sponsor provides specific equipment or supplies

3. Intellectual Property Rights: Required when study may generate patentable inventions or IP

4. Subject Injury Provisions: Include when not covered by standard insurance provisions

5. Publication Review Process: Detailed publication review procedures when required by sponsor

6. Data Sharing and Transfer: Include when data will be shared across borders or with multiple parties

7. Quality Assurance: Detailed quality control measures when required by sponsor

8. Budget Contingencies: Include when payment terms are complex or contingent on multiple factors

1. Schedule A - Protocol: The approved study protocol

2. Schedule B - Budget and Payment Schedule: Detailed breakdown of payments and payment timing

3. Schedule C - Timeline: Study timeline and key milestones

4. Schedule D - Required Reports: List and templates of required study reports

5. Schedule E - Data Protection Requirements: Detailed GDPR compliance requirements and procedures

6. Appendix 1 - CV and Credentials: Investigator's curriculum vitae and relevant credentials

7. Appendix 2 - Insurance Certificates: Copies of required insurance certificates

8. Appendix 3 - Form of Informed Consent: Approved informed consent template

9. Appendix 4 - Delegation of Authority Log: Template for recording staff responsibilities and delegations