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Investigator Agreement Template for United Arab Emirates

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Key Requirements PROMPT example:

Investigator Agreement

"I need an Investigator Agreement for a Phase III clinical trial of a new diabetes medication, compliant with UAE regulations, where we'll have multiple sub-investigators and need specific provisions for biological sample handling and international data sharing."

Document background
The Investigator Agreement serves as a critical document in clinical research operations within the United Arab Emirates, establishing the legal and operational framework between research sponsors and clinical investigators. This agreement is essential when initiating clinical trials or research studies in UAE healthcare facilities, ensuring compliance with local regulations including UAE Federal Law No. 4 of 2016 on Medical Liability and Cabinet Resolution No. 40 of 2019. The document outlines investigator responsibilities, study procedures, compliance requirements, data protection measures, and compensation terms. It is designed to protect all parties' interests while ensuring research quality and patient safety in accordance with UAE healthcare regulations and international good clinical practice standards.
Suggested Sections

1. Parties: Identifies the contracting parties: typically the research sponsor/institution and the principal investigator

2. Background: Outlines the context of the research study and the purpose of the agreement

3. Definitions: Defines key terms used throughout the agreement

4. Scope of Services: Details the investigator's responsibilities and scope of work in conducting the study

5. Compliance with Protocol: Establishes requirements for adherence to the study protocol and any approved amendments

6. Regulatory Compliance: Specifies compliance requirements with UAE laws, regulations, and ethical guidelines

7. Study Team and Delegation: Outlines requirements for study team members and delegation of responsibilities

8. Patient Informed Consent: Details requirements for obtaining and documenting informed consent

9. Data Collection and Reporting: Specifies requirements for data collection, recording, and reporting

10. Confidentiality: Establishes confidentiality obligations regarding study information and patient data

11. Intellectual Property: Addresses ownership and rights to study data, inventions, and publications

12. Compensation: Details payment terms, schedule, and conditions for the investigator's services

13. Term and Termination: Specifies agreement duration and conditions for termination

14. Insurance and Indemnification: Outlines insurance requirements and indemnification provisions

15. General Provisions: Includes standard legal provisions such as governing law, dispute resolution, and notices

Optional Sections

1. Publication Rights: Detailed provisions regarding rights and procedures for publishing study results, used when publication is anticipated

2. Equipment and Supplies: Details regarding provision and handling of study equipment and supplies, included when sponsor provides specific equipment

3. Study Budget: Detailed budget provisions, used when complex payment structures are involved

4. Monitoring and Audits: Specific provisions for study monitoring and audits, included for complex studies

5. Safety Reporting: Detailed safety reporting requirements, included for high-risk studies

6. Electronic Systems: Provisions regarding use of electronic data capture or other systems, included when specific systems are required

7. Biological Samples: Provisions for handling biological samples, included when study involves sample collection

8. Record Retention: Specific requirements for record retention, included when exceeding standard requirements

Suggested Schedules

1. Schedule 1 - Study Protocol: The approved protocol detailing study procedures and requirements

2. Schedule 2 - Payment Schedule: Detailed breakdown of payment amounts, timelines, and conditions

3. Schedule 3 - Budget Breakdown: Itemized study budget including per-patient costs and overhead

4. Schedule 4 - Required Documentation: List of essential documents required for study conduct

5. Appendix A - Form of Informed Consent: Approved informed consent template

6. Appendix B - Data Protection Requirements: Specific requirements for handling patient data under UAE law

7. Appendix C - Study Team Members: List of approved study team members and their qualifications

8. Appendix D - Delegation Log Template: Template for documenting delegation of study responsibilities

Authors

Alex Denne

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

Relevant legal definitions



















































Clauses





































Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Academic Medical Research

Contract Research Organizations

Relevant Teams

Legal

Clinical Operations

Medical Affairs

Regulatory Affairs

Research Administration

Compliance

Clinical Research

Contract Management

Medical Writing

Site Management

Relevant Roles

Principal Investigator

Clinical Research Coordinator

Medical Director

Research Site Manager

Clinical Trial Manager

Legal Counsel

Regulatory Affairs Manager

Ethics Committee Chairman

Clinical Operations Director

Healthcare Facility Director

Research Compliance Officer

Medical Affairs Manager

Contract Manager

Study Monitor

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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