1. Parties: Identification of the contracting parties including the research sponsor, research organization, and principal investigator
2. Background: Context of the research, purpose of the agreement, and brief description of the clinical study
3. Definitions: Definitions of key terms used throughout the agreement
4. Scope of Services: Detailed description of the clinical research to be conducted, including study objectives and design
5. Regulatory Compliance: Obligations regarding compliance with Indonesian laws, regulations, and ethical requirements
6. Study Protocol: Reference to and incorporation of the approved study protocol
7. Ethics Committee Approval: Requirements and process for obtaining and maintaining ethical clearance
8. Informed Consent: Requirements and procedures for obtaining participant informed consent
9. Personnel and Facilities: Requirements for research staff, facilities, and equipment
10. Data Management: Procedures for data collection, storage, protection, and reporting
11. Safety Reporting: Requirements for adverse event reporting and safety monitoring
12. Quality Assurance: Quality control measures and monitoring requirements
13. Confidentiality: Provisions for protecting confidential information and research data
14. Intellectual Property: Ownership and rights to research results, data, and innovations
15. Publication Rights: Terms governing the publication of study results
16. Payment Terms: Financial arrangements, payment schedule, and budget details
17. Term and Termination: Duration of the agreement and termination provisions
18. Insurance and Indemnification: Insurance requirements and allocation of liabilities
19. Governing Law: Specification of Indonesian law as governing law and jurisdiction
20. General Provisions: Standard contractual provisions including notices, amendments, and assignment
