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1. Research Grant Provisions: Required when the study involves grant funding, detailing grant management and reporting requirements

2. Equipment and Materials: Needed when sponsor provides specific equipment or materials, detailing handling and ownership

3. Biological Samples: Required when the study involves collection and storage of biological samples

4. Third Party Agreements: Needed when other parties (e.g., vendors, subcontractors) are involved in the study

5. Archive and Record Retention: Detailed requirements for long-term storage of study documents when beyond standard retention periods

6. Emergency Procedures: Required for high-risk studies needing specific emergency protocols

7. Quality Assurance: Detailed quality control procedures when beyond standard requirements

8. Translation Requirements: Needed when study documents require translation into local languages

1. Protocol: Detailed clinical trial protocol

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

3. Patient Compensation Schedule: Details of patient reimbursement and compensation

4. Study Timeline: Detailed schedule of study activities and milestones

5. Required Documentation: List of essential documents and forms

6. Insurance Certificates: Copies of required insurance documentation

7. Data Processing Agreement: Detailed GDPR-compliant data processing terms

8. Study Team Members: List of approved study team members and their qualifications

9. Delegation of Authority Log: Documentation of assigned study responsibilities

10. Form of Informed Consent: Template informed consent documents