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Clinical Trial Agreement

Clinical Trial Agreement Template for United Arab Emirates

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Key Requirements PROMPT example:

Clinical Trial Agreement

"I need a Clinical Trial Agreement for a Phase III diabetes drug trial scheduled to begin in March 2025, involving multiple research sites across Dubai and Abu Dhabi, with specific provisions for biological sample handling and data protection compliance."

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Document background
The Clinical Trial Agreement serves as the primary legal instrument for conducting clinical research in the United Arab Emirates. It is essential when any pharmaceutical company, research institution, or healthcare facility plans to conduct clinical trials within the UAE jurisdiction. The agreement must comply with UAE federal healthcare laws, including Federal Law No. 4 of 2016 (Medical Liability Law) and Cabinet Decision No. 31 of 2021 (Good Clinical Practice), while also adhering to international standards. This document is crucial for defining the relationships between sponsors, research institutions, investigators, and regulatory authorities, establishing protocols for patient safety, data protection, and trial management. It includes detailed provisions for financial arrangements, intellectual property rights, publication policies, and specific UAE regulatory compliance requirements, making it fundamental for any clinical research initiative in the UAE healthcare sector.
Suggested Sections

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

2. Background: Context of the clinical trial, including the purpose of the study and basic framework of collaboration

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

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

5. Regulatory Compliance: Obligations regarding UAE regulatory requirements, including MOHAP approvals and ethical committee clearances

6. Trial Governance: Management structure, roles and responsibilities of each party, and decision-making processes

7. Financial Arrangements: Payment terms, budget details, and financial responsibilities of each party

8. Confidentiality: Protection of confidential information and trade secrets, including trial data and results

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

10. Data Protection: Compliance with UAE data protection laws and handling of patient information

11. Publication Rights: Terms governing the publication of trial results and academic papers

12. Liability and Indemnification: Allocation of risks, insurance requirements, and indemnification obligations

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

14. General Provisions: Standard legal clauses including governing law, dispute resolution, and entire agreement

Optional Sections

1. Sub-contracting: Terms for engaging third-party contractors - include when trial involves external service providers

2. Equipment and Materials: Provisions regarding supply and use of trial equipment - include when sponsor provides specific equipment

3. Multi-center Provisions: Specific terms for multi-center trials - include when trial is conducted across multiple sites

4. Biological Samples: Handling and ownership of biological samples - include when trial involves sample collection

5. Translation Requirements: Requirements for document translation - include when trial documents need Arabic translation

6. Emergency Procedures: Special procedures for medical emergencies - include for high-risk trials

7. Technology Transfer: Terms for any technology or knowledge transfer - include when relevant to trial objectives

Suggested Schedules

1. Trial Protocol: Detailed protocol approved by regulatory authorities and ethics committees

2. Budget and Payment Schedule: Detailed breakdown of costs, payment terms, and timeline

3. Patient Informed Consent Form: Approved form for obtaining patient consent in English and Arabic

4. Insurance Certificates: Copies of required insurance policies and certificates

5. Site Requirements: Specific requirements for trial site facilities and personnel

6. Data Management Plan: Procedures for data collection, storage, and handling

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

8. Quality Assurance Requirements: Standards and procedures for quality control and monitoring

9. Form of Progress Reports: Templates and requirements for regular trial progress reporting

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈË°æ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co
Relevant legal definitions








































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Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Life Sciences

Medical Education

Research & Development

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Medical Affairs

Research & Development

Compliance

Quality Assurance

Contract Management

Clinical Research

Medical Writing

Relevant Roles

Clinical Research Director

Medical Director

Legal Counsel

Regulatory Affairs Manager

Principal Investigator

Clinical Trial Manager

Research Coordinator

Compliance Officer

Medical Affairs Manager

Contract Manager

Ethics Committee Member

Quality Assurance Manager

Site Director

Chief Medical Officer

Research & Development Head

Industries








Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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