Clinical Trial Contract Template for Saudi Arabia

The Clinical Trial Contract serves as the primary legal instrument for establishing and governing clinical research relationships in Saudi Arabia. This document is essential when a pharmaceutical company, research institution, or other sponsor wishes to conduct clinical trials within Saudi jurisdiction. The contract must comply with Saudi Food and Drug Authority (SFDA) regulations, National Committee of Bioethics (NCBE) guidelines, and Sharia Law principles. It typically includes comprehensive provisions covering trial protocol implementation, participant safety, data protection, financial arrangements, and regulatory compliance. The document is structured to protect all stakeholders' interests while ensuring the ethical conduct of research and compliance with local and international standards. Key considerations include SFDA approval requirements, informed consent procedures, data protection under PDPL, and specific Saudi Arabian healthcare facility regulations.

1. Parties: Identification of all contracting parties including sponsor, institution, principal investigator, and any other relevant parties

2. Background: Context of the clinical trial, including the study drug/device and general purpose of the research

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

4. Scope of Trial: Detailed description of the clinical trial, including objectives, duration, and number of subjects

5. Regulatory Compliance: Compliance requirements with SFDA regulations, GCP guidelines, and other applicable laws

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 committees

8. Subject Recruitment and Informed Consent: Requirements and procedures for participant recruitment and obtaining informed consent

9. Financial Arrangements: Payment terms, budget details, and financial responsibilities

10. Confidentiality: Provisions for protecting confidential information and trial data

11. Intellectual Property: Ownership and rights regarding trial data, inventions, and publications

12. Data Management and Protection: Requirements for data collection, storage, protection, and compliance with PDPL

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

14. Insurance and Indemnification: Insurance requirements and indemnification provisions

15. Publication Rights: Terms governing the publication of trial results

16. Term and Termination: Duration of agreement and conditions for termination

17. Governing Law and Dispute Resolution: Application of Saudi law and dispute resolution mechanisms

18. General Provisions: Standard contractual provisions including notices, amendments, and assignment