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The Clinical Study Agreement is essential for any clinical research conducted in Qatar, serving as the primary contractual framework between pharmaceutical companies, research institutions, and healthcare professionals. This document is required when initiating clinical trials or research studies in Qatar and must comply with Law No. 3 of 2016, MOPH guidelines, and Qatar Research Ethics Committee requirements. The agreement covers crucial aspects such as study protocol implementation, participant protection, data handling, financial terms, and regulatory compliance. It includes specific provisions adapted to Qatar's healthcare system and legal framework, ensuring alignment with local regulations while maintaining international research standards. The document is particularly important given Qatar's growing role in medical research and its commitment to developing its healthcare sector in line with Qatar National Vision 2030.

1. Parties: Identification of all parties including Sponsor, Institution, Principal Investigator, and any Contract Research Organization (CRO) if applicable

2. Background: Context of the clinical study, purpose, and general objectives

3. Definitions: Detailed definitions of technical terms, roles, and key concepts used throughout the agreement

4. Study Protocol: Reference to and incorporation of the approved study protocol, including compliance requirements

5. Regulatory Compliance: Obligations regarding QREC approval, MOPH requirements, and other regulatory obligations

6. Roles and Responsibilities: Detailed obligations of each party including Institution, Principal Investigator, and Sponsor

7. Study Drug/Device: Provisions regarding supply, storage, handling, and accountability of study materials

8. Patient Recruitment and Consent: Requirements for patient recruitment, informed consent process, and documentation

9. Data Management and Protection: Requirements for data collection, processing, and protection in compliance with Qatar's data protection laws

10. Confidentiality: Provisions for protecting confidential information of all parties and study participants

11. Publication Rights: Terms governing the publication of study results and academic rights

12. Intellectual Property: Ownership and rights regarding study data, inventions, and other intellectual property

13. Payment Terms: Financial arrangements, payment schedule, and related financial obligations

14. Term and Termination: Duration of agreement, renewal terms, and termination conditions

15. Insurance and Indemnification: Insurance requirements and indemnification obligations of parties

16. Governing Law and Dispute Resolution: Specification of Qatar law as governing law and dispute resolution mechanisms

17. General Provisions: Standard legal provisions including notices, amendments, and assignment