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1. Emergency Procedures: Special procedures for handling medical emergencies, required if the trial involves high-risk interventions

2. Pandemic/Emergency Provisions: Special provisions for trials conducted during health emergencies, needed if trial is pandemic-related

3. Third Party Agreements: Required if external vendors or laboratories are involved

4. International Data Transfer: Required if data will be transferred outside India

5. Biological Sample Management: Required if trial involves collection and storage of biological samples

6. Remote Monitoring Provisions: Required if trial includes remote patient monitoring or telemedicine components

7. Local Ethics Committee Interface: Special provisions for expedited ethics committee review processes

1. Schedule 1 - Trial Protocol: Detailed protocol including accelerated timeline justification

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

3. Schedule 3 - Patient Informed Consent Form: Template of participant informed consent document

4. Schedule 4 - Data Protection Protocol: Specific procedures for handling sensitive patient data

5. Schedule 5 - Safety Reporting Procedures: Protocols for adverse event reporting and safety monitoring

6. Schedule 6 - Quality Assurance Requirements: Standards and procedures for maintaining trial quality

7. Appendix A - Key Personnel: List of key team members and their responsibilities

8. Appendix B - Timeline and Milestones: Detailed project schedule with accelerated timelines

9. Appendix C - Required Documentation: List of essential documents and regulatory submissions

10. Appendix D - Insurance Certificates: Copies of required insurance coverage documents