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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."
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
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
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
Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Clinical Research
Healthcare Technology
Academic Medical Research
Contract Research Organizations
Legal
Clinical Operations
Medical Affairs
Regulatory Affairs
Research Administration
Compliance
Clinical Research
Contract Management
Medical Writing
Site Management
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
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