Accelerated Clinical Trial Agreement Template for Canada

1. Subject Injury: Specific provisions for handling and compensating trial-related injuries, required if not covered under general indemnification

2. Equipment and Supplies: Terms for provision and use of specialized equipment, needed if sponsor provides specific equipment

3. Multi-Center Trial Provisions: Additional terms for multi-center studies, required for trials conducted at multiple sites

4. Biological Samples: Provisions for handling, storage, and future use of biological samples, needed if trial involves specimen collection

5. Data Protection: Specific data protection obligations beyond general confidentiality, required for trials involving sensitive personal data

6. COVID-19 Provisions: Special provisions for pandemic-related contingencies, needed during public health emergencies

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

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

3. Schedule C - Timeline and Milestones: Specific study timelines, recruitment targets, and accelerated conduct commitments

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

5. Schedule E - Key Personnel: List of key study team members and their responsibilities

6. Appendix 1 - Form of Informed Consent: Approved informed consent template

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

8. Appendix 3 - Data Protection Requirements: Detailed data protection and privacy requirements

9. Appendix 4 - Quality Requirements: Specific quality control and assurance requirements