Clinical Study Agreement Template for Belgium

1. Study Drug Supply: Specific terms for drug handling and accountability - include when the study involves investigational medicinal products

2. Equipment Provision: Terms for supplied equipment management - include when sponsor provides specific equipment for the study

3. Sub-Investigator Obligations: Additional terms for other investigators - include when multiple investigators are involved

4. Monitoring and Auditing: Specific provisions for study monitoring - include for complex studies requiring enhanced oversight

5. Multi-Center Study Provisions: Additional terms for multi-center coordination - include when study involves multiple sites

6. Biological Sample Management: Terms for handling biological specimens - include when study involves sample collection

7. Archive Requirements: Specific archiving obligations - include when special record retention requirements apply

8. Translation Requirements: Provisions for document translation - include when study documents need translation to local languages

1. Schedule 1 - Protocol: The approved study protocol including all amendments

2. Schedule 2 - Budget and Payment Schedule: Detailed financial breakdown and payment terms

3. Schedule 3 - Division of Responsibilities: Matrix of responsibilities between sponsor, institution, and investigator

4. Schedule 4 - Data Processing Agreement: Detailed GDPR-compliant data processing terms

5. Schedule 5 - Insurance Certificates: Proof of required insurance coverage

6. Schedule 6 - Form of Patient Informed Consent: Approved informed consent forms and patient information

7. Schedule 7 - Equipment List: Detailed list of provided equipment and terms of use

8. Schedule 8 - Study Timeline: Expected milestones and study completion timeline

9. Appendix A - EC/Regulatory Approvals: Copies of ethics committee and regulatory authority approvals

10. Appendix B - CV and Licenses: Principal Investigator's credentials and relevant certifications