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Investigator Agreement Template for Australia

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Key Requirements PROMPT example:

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."

Document background
The Investigator Agreement serves as the primary contract between research sponsors (such as pharmaceutical companies or CROs) and medical professionals conducting clinical trials in Australia. This document is essential when initiating any clinical research study and must comply with Australian regulatory frameworks, including the Therapeutic Goods Act 1989, NHMRC guidelines, and state-specific health regulations. The agreement outlines crucial aspects such as study protocol adherence, participant safety measures, data management requirements, confidentiality obligations, and financial arrangements. It protects all parties' interests while ensuring research integrity and compliance with Australian clinical trial standards and ethical requirements.
Suggested Sections

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

Optional Sections

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

Suggested Schedules

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

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

Pharmaceuticals

Biotechnology

Healthcare

Medical Devices

Clinical Research

Academic Research

Healthcare Technology

Life Sciences

Relevant Teams

Legal

Clinical Operations

Research & Development

Regulatory Affairs

Compliance

Clinical Research

Medical Affairs

Contracts Administration

Ethics Committee

Site Management

Relevant Roles

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

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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