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The Clinical Trial Contract serves as the primary legal instrument for establishing and governing clinical research relationships in Indonesia. This document is essential when a pharmaceutical company, research institution, or medical device manufacturer intends to conduct clinical trials within Indonesian jurisdiction. It must comply with various Indonesian regulations, including BPOM Regulation No. 21 of 2015, the Health Law (Law No. 36 of 2009), and Indonesian Good Clinical Practice Guidelines. The contract addresses critical aspects such as regulatory compliance, patient safety, data protection, financial arrangements, and risk allocation, while considering unique local requirements and healthcare system characteristics. It's particularly important that the Clinical Trial Contract incorporates specific Indonesian regulatory requirements while maintaining alignment with international clinical research standards.

1. Parties: Identification of all contracting parties including sponsor, institution/trial site, and principal investigator

2. Background: Context of the clinical trial, including the drug/device being tested and trial purpose

3. Definitions: Detailed definitions of technical and legal terms used throughout the agreement

4. Scope of Trial: Detailed description of the clinical trial, including protocol reference and trial objectives

5. Regulatory Compliance: Obligations regarding BPOM regulations, ethics committee approvals, and other regulatory requirements

6. Roles and Responsibilities: Detailed obligations of each party including sponsor, institution, and principal investigator

7. Trial Governance: Management structure, decision-making processes, and oversight procedures

8. Patient Recruitment and Consent: Requirements and procedures for patient recruitment and informed consent

9. Trial Documentation: Requirements for maintaining trial records, case report forms, and other documentation

10. Quality Management: Quality control procedures, monitoring, and audit requirements

11. Safety Reporting: Procedures for adverse event reporting and safety monitoring

12. Confidentiality: Protection of confidential information and trial data

13. Intellectual Property: Ownership and rights to trial data, results, and inventions

14. Publication Rights: Terms for publishing trial results and academic publications

15. Financial Terms: Payment schedule, costs, and financial responsibilities

16. Insurance and Indemnification: Insurance requirements and allocation of liabilities

17. Term and Termination: Duration of agreement and termination provisions

18. General Provisions: Standard legal provisions including governing law, dispute resolution, and notices