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Investigator Agreement
"I need an Investigator Agreement for a Phase III clinical trial of a new diabetes medication, to be conducted at three hospitals in Kuala Lumpur, with specific provisions for handling biological samples and remote monitoring requirements."
1. Parties: Identifies the contracting parties: typically the sponsor/institution and the investigator
2. Background: Contextual information about the study and the purpose of the agreement
3. Definitions: Defines key terms used throughout the agreement
4. Scope of Services: Details the investigator's roles, responsibilities, and services to be provided
5. Compliance with Laws and Regulations: Requirements for compliance with Malaysian laws, GCP, and other applicable regulations
6. Study Protocol: Requirements for adherence to the study protocol and procedures for amendments
7. Patient Recruitment and Informed Consent: Guidelines for participant recruitment and obtaining informed consent
8. Data Collection and Reporting: Requirements for data collection, documentation, and reporting obligations
9. Confidentiality: Obligations regarding confidential information and study data
10. Intellectual Property: Rights and obligations regarding study-related intellectual property
11. Publication Rights: Terms governing the publication of study results
12. Compensation and Payment: Payment terms, schedule, and conditions
13. Term and Termination: Duration of the agreement and conditions for termination
14. Insurance and Indemnification: Insurance requirements and indemnification provisions
15. Governing Law and Jurisdiction: Specifies Malaysian law as governing law and jurisdiction for disputes
16. General Provisions: Standard contractual provisions including notices, amendments, and assignment
1. Sub-Investigator Obligations: Required when sub-investigators will be involved in the study
2. Equipment and Supplies: Include when specific equipment or supplies are provided for the study
3. Biological Samples: Required when the study involves collection and handling of biological samples
4. Study Drug Management: Include for studies involving investigational medicinal products
5. Remote Monitoring Provisions: Include when remote monitoring of study activities is required
6. Translation Requirements: Include when study materials require translation to local languages
7. Safety Reporting: Detailed section required for high-risk studies or when handling specific safety concerns
8. Archive and Record Retention: Extended provisions when specific archiving requirements exist
1. Schedule 1 - Study Protocol: Detailed protocol for the clinical study
2. Schedule 2 - Payment Schedule: Detailed breakdown of payment amounts, timing, and conditions
3. Schedule 3 - Timeline and Milestones: Key dates and deliverables for the study
4. Schedule 4 - Required Documentation: List of essential documents required for study conduct
5. Schedule 5 - Data Protection Requirements: Specific requirements for handling personal data under Malaysian law
6. Appendix A - Investigator's CV: Principal Investigator's curriculum vitae and qualifications
7. Appendix B - Facility Requirements: Specifications for facility and equipment requirements
8. Appendix C - Study Team Members: List of approved study team members and their roles
Authors
Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Clinical Research
Academic Research
Healthcare Technology
Life Sciences
Legal
Clinical Operations
Medical Affairs
Regulatory Affairs
Research & Development
Clinical Research
Compliance
Contract Management
Medical Writing
Research Ethics
Clinical Research Director
Principal Investigator
Medical Director
Clinical Trial Manager
Research Coordinator
Legal Counsel
Regulatory Affairs Manager
Clinical Operations Manager
Medical Officer
Research Compliance Officer
Contract Manager
Study Manager
Chief Medical Officer
Research Ethics Officer
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