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Investigator Agreement
"I need an Investigator Agreement for a Phase II clinical trial of a new diabetes medication, to be conducted at three hospitals in Melbourne, with a planned start date of March 2025 and involving collection of biological samples."
1. Parties: Identifies the contracting parties - typically the sponsor/CRO and the principal investigator
2. Background: Context of the clinical trial and 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 Laws and Regulations: Obligations to comply with applicable laws, regulations, and guidelines
6. Study Protocol: Requirements for adherence to the study protocol and allowed deviations
7. Patient Recruitment and Informed Consent: Requirements for participant recruitment and obtaining informed consent
8. Data Collection and Reporting: Obligations regarding data collection, recording, and reporting requirements
9. Confidentiality: Provisions for handling confidential information and maintaining privacy
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 Terms: Payment schedule, amounts, and conditions for payment
13. Term and Termination: Duration of agreement and circumstances for termination
14. Insurance and Indemnification: Insurance requirements and allocation of liability
15. General Provisions: Standard legal provisions including notices, assignment, and governing law
1. Sub-Investigators: Required when other investigators will assist in conducting the study
2. Equipment and Supplies: Include when specific equipment or supplies are provided for the study
3. Institution Obligations: Required when the agreement involves an institution where the research will be conducted
4. Study Drug Management: Include for drug trials requiring specific handling and accountability procedures
5. Monitoring and Audits: Detailed provisions for study monitoring when beyond standard requirements
6. Biological Samples: Required when the study involves collection and handling of biological specimens
7. Data Protection: Enhanced data protection provisions for international studies or sensitive data
8. Translation Requirements: Include when study materials require translation to local languages
1. Schedule 1 - Study Protocol: Detailed protocol for conducting the clinical trial
2. Schedule 2 - Payment Schedule: Detailed breakdown of payment amounts, timing, and conditions
3. Schedule 3 - Budget: Itemized study budget including per-patient costs and overhead
4. Schedule 4 - Timeline: Key study milestones and deadlines
5. Schedule 5 - Required Reports: List and templates of required study reports
6. Appendix A - Form of Informed Consent: Template or approved form of patient informed consent
7. Appendix B - Confidentiality Agreement: Form of confidentiality agreement for study staff
8. Appendix C - CV and Licenses: Investigator's curriculum vitae and professional licenses
Authors
Pharmaceuticals
Biotechnology
Healthcare
Medical Devices
Clinical Research
Academic Research
Healthcare Technology
Life Sciences
Legal
Clinical Operations
Research & Development
Regulatory Affairs
Compliance
Clinical Research
Medical Affairs
Contracts Administration
Ethics Committee
Site Management
Clinical Research Director
Principal Investigator
Clinical Trial Manager
Research Coordinator
Medical Director
Legal Counsel
Regulatory Affairs Manager
Contract Manager
Clinical Operations Manager
Research Administrator
Ethics Committee Coordinator
Site Manager
Chief Medical Officer
Research Compliance Officer
Clinical Research Associate
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