1. Parties: Identification of contracting parties including Sponsor, Research Institution, Principal Investigator, and any relevant third parties
2. Background: Context of the clinical study, brief description of the investigational product, and purpose of the agreement
3. Definitions: Detailed definitions of technical terms, regulatory references, and agreement-specific terminology
4. Scope of Work: Detailed description of the clinical study, including protocol reference and key objectives
5. Regulatory Compliance: Obligations regarding DRAP regulations, ICH-GCP guidelines, and other applicable laws
6. Principal Investigator Obligations: Specific duties, responsibilities, and commitments of the Principal Investigator
7. Institution Obligations: Responsibilities of the research institution including facility provision and staff support
8. Sponsor Obligations: Responsibilities of the sponsor including product supply, training, and support
9. Study Timeline: Start date, duration, key milestones, and completion criteria
10. Financial Provisions: Payment terms, schedule, budget details, and financial responsibilities
11. Confidentiality: Protection of confidential information, study data, and trade secrets
12. Intellectual Property: Ownership and rights to study results, inventions, and publications
13. Data Management: Requirements for data collection, storage, protection, and sharing
14. Safety Reporting: Procedures for adverse event reporting and safety monitoring
15. Insurance and Indemnification: Insurance requirements and indemnification provisions
16. Publication Rights: Terms for publishing study results and academic presentations
17. Term and Termination: Duration of agreement, renewal terms, and termination conditions
18. Governing Law: Specification of Pakistani law as governing law and jurisdiction
19. General Provisions: Standard legal provisions including notices, amendments, and assignment
