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Clinical Study Agreement

Clinical Study Agreement Template for Australia

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Key Requirements PROMPT example:

Clinical Study Agreement

"I need an Australian Clinical Study Agreement for a Phase II multi-center trial of a new diabetes medication, involving three research institutions in Victoria and New South Wales, with the trial scheduled to commence in March 2025."

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Document background
The Clinical Study Agreement serves as the foundational legal document for conducting clinical trials in Australia, establishing the framework for collaboration between pharmaceutical/biotech companies, research institutions, and healthcare professionals. This agreement is essential when implementing clinical trials that must comply with the Therapeutic Goods Act 1989, ICH-GCP guidelines, and Australian ethical research standards. It details crucial aspects including protocol implementation, financial arrangements, regulatory compliance, data protection, and risk allocation. The document is specifically designed to meet Australian legal requirements while protecting all parties' interests and ensuring participant safety. Use this agreement when initiating any clinical trial in Australia, whether for drug development, medical devices, or other therapeutic goods research.
Suggested Sections

1. Parties: Identifies all contracting parties including Sponsor, Institution, and Principal Investigator

2. Background: Outlines the context of the clinical study and each party's relevant qualifications and interests

3. Definitions: Defines key terms used throughout the agreement

4. Study Conduct: Details the protocol implementation, compliance requirements, and study procedures

5. Regulatory Compliance: Specifies obligations regarding regulatory approvals, ethics committee requirements, and applicable laws

6. Personnel: Defines roles, responsibilities, and qualifications of key study personnel

7. Financial Arrangements: Details payment terms, budget, and financial obligations

8. Confidentiality: Outlines confidentiality obligations and handling of proprietary information

9. Intellectual Property: Addresses ownership and rights to study data, results, and innovations

10. Publication Rights: Establishes terms for publishing study results and academic rights

11. Indemnification: Details indemnification obligations and liability allocation

12. Insurance: Specifies insurance requirements and coverage obligations

13. Term and Termination: Defines agreement duration and termination conditions

14. General Provisions: Includes standard legal provisions like governing law, dispute resolution, and notices

Optional Sections

1. Multi-Center Provisions: Additional terms for multi-center studies, used when the trial is conducted at multiple sites

2. Equipment and Materials: Specific provisions for specialized equipment or materials provided for the study

3. Biological Samples: Terms for handling, storage, and future use of biological samples, if applicable

4. Data Protection: Enhanced data protection provisions for studies involving sensitive personal data or international data transfers

5. Sub-Study Provisions: Terms for potential sub-studies or additional research components

6. Third Party Agreements: Provisions regarding agreements with third party service providers or collaborators

7. Translation Requirements: Provisions for translation of study materials if involving non-English speaking participants

Suggested Schedules

1. Schedule 1 - Protocol: Detailed clinical trial protocol including study design and procedures

2. Schedule 2 - Budget: Detailed financial breakdown including payment schedule and cost allocation

3. Schedule 3 - Payment Terms: Specific payment procedures, timelines, and invoicing requirements

4. Schedule 4 - Insurance Certificates: Copies of required insurance policies and certificates

5. Schedule 5 - Study Timeline: Detailed timeline of study milestones and deadlines

6. Appendix A - Key Personnel: List of key study personnel and their qualifications

7. Appendix B - Reporting Requirements: Detailed reporting obligations and templates

8. Appendix C - Data Management Plan: Specific procedures for data collection, storage, and handling

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈË°æ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co
Relevant legal definitions















































Clauses









































Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Academic Research

Contract Research

Life Sciences

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research & Development

Medical Affairs

Compliance

Quality Assurance

Clinical Research

Contract Management

Ethics & Governance

Relevant Roles

Clinical Research Director

Medical Director

Legal Counsel

Regulatory Affairs Manager

Clinical Trial Manager

Principal Investigator

Research Coordinator

Contracts Manager

Compliance Officer

Chief Medical Officer

Research Ethics Officer

Clinical Operations Manager

Site Director

Study Monitor

Quality Assurance Manager

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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