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Accelerated Clinical Trial Agreement

Accelerated Clinical Trial Agreement Template for Australia

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Key Requirements PROMPT example:

Accelerated Clinical Trial Agreement

"I need an Accelerated Clinical Trial Agreement for a Phase II trial of a new cancer drug to be conducted across three hospitals in Melbourne, with trial commencement planned for March 2025; the agreement must include specific provisions for biological sample handling and storage."

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Document background
The Accelerated Clinical Trial Agreement serves as a crucial document in the Australian healthcare and research landscape, designed to expedite the initiation and implementation of clinical trials while maintaining strict compliance with regulatory requirements. This agreement type was developed in response to the need for faster trial commencement without compromising on legal and safety standards. It incorporates standardized terms pre-approved by major Australian research institutions and pharmaceutical companies, reducing negotiation time and legal review periods. The document covers essential elements including trial protocol compliance, participant safety, data protection, financial arrangements, and liability allocation, while adhering to requirements set by the Therapeutic Goods Administration (TGA) and National Health and Medical Research Council (NHMRC). It is particularly valuable in situations requiring rapid trial setup, such as urgent medical research or time-sensitive studies.
Suggested Sections

1. Parties: Identification of all parties to the agreement including the sponsor, institution, and principal investigator

2. Background: Context of the clinical trial and purpose of the agreement

3. Definitions: Definitions of key terms used throughout the agreement

4. Trial Conduct: Core obligations regarding trial conduct, compliance with protocol and applicable regulations

5. Regulatory Compliance: Compliance with CTN scheme, TGA requirements, and other applicable laws

6. Timeline and Performance: Trial commencement, duration, and key performance metrics

7. Financial Arrangements: Payment terms, schedule, and financial obligations

8. Confidentiality: Protection and handling of confidential information

9. Intellectual Property: Ownership and rights to trial data, results, and innovations

10. Publication Rights: Terms for publishing trial results and academic freedom provisions

11. Insurance and Indemnity: Insurance requirements and indemnification obligations

12. Term and Termination: Duration of agreement and termination provisions

13. General Provisions: Standard legal provisions including governing law, dispute resolution, and notices

Optional Sections

1. Multi-Center Trial Provisions: Additional terms for trials conducted across multiple sites

2. Equipment and Materials: Terms for provision and use of specialized equipment or materials

3. Sub-contractor Arrangements: Terms governing the use of sub-contractors or third-party service providers

4. Biological Samples: Specific provisions for collection, storage, and use of biological samples

5. Data Protection Officer: Specific provisions when a dedicated data protection officer is required

6. Emergency Procedures: Special provisions for emergency situations or pandemic conditions

7. Pharmacovigilance: Additional safety monitoring and reporting requirements for certain types of trials

Suggested Schedules

1. Schedule 1 - Protocol: Detailed clinical trial protocol including all amendments

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

3. Schedule 3 - Timeline: Detailed timeline of trial milestones and deadlines

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

5. Schedule 5 - Form of Indemnity: Standard form of indemnity as per Medicines Australia guidelines

6. Schedule 6 - Personnel: List of key personnel and their roles

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

8. Appendix B - Safety Reporting Procedures: Procedures for adverse event reporting and safety monitoring

9. Appendix C - Quality Assurance Requirements: Quality control and assurance procedures

Authors

Alex Denne

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

Linkedin in social icon imageX social icon image
alex.den.21@genieai.co
Relevant legal definitions
Adverse Event
Agreement
Applicable Law
Approved Protocol
Background Intellectual Property
Clinical Trial
Clinical Trial Materials
Commencement Date
Confidential Information
Contract Research Organisation (CRO)
CTN Scheme
Data
Effective Date
Ethics Committee
Good Clinical Practice (GCP)
Human Research Ethics Committee (HREC)
Institution
Intellectual Property Rights
Investigator
Investigator's Brochure
Material
Medical Records
Medicines Australia
NHMRC
Participant
Personal Information
Personnel
Principal Investigator
Protocol
Regulatory Authority
Research Staff
Serious Adverse Event
Site
Sponsor
Study
Study Completion
Study Drug
Study Intellectual Property
Study Product
Study Results
Sub-Investigator
Subject
TGA
Timeline
Trial
Trial Data
Trial Documentation
Trial Participant
Trial Period
Trial Site
Clauses
Definitions
Interpretation
Trial Conduct
Regulatory Compliance
Ethics Approval
Protocol Adherence
Study Drug Supply
Patient Safety
Data Management
Privacy Protection
Confidentiality
Intellectual Property
Publication Rights
Financial Provisions
Payment Terms
Insurance
Indemnification
Liability
Force Majeure
Term and Duration
Termination
Dispute Resolution
Governing Law
Assignment
Variation
Notice Requirements
Entire Agreement
Severability
Representations and Warranties
Record Keeping
Audit Rights
Quality Assurance
Personnel Requirements
Site Access
Monitoring and Reporting
Safety Reporting
Amendment Procedures
Survival Clauses
Relevant Industries

Healthcare

Pharmaceutical

Biotechnology

Medical Research

Clinical Trials

Medical Devices

Contract Research

Healthcare Technology

Life Sciences

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research & Development

Medical Affairs

Clinical Research

Compliance

Quality Assurance

Contract Management

Ethics Committee

Site Management

Research Administration

Relevant Roles

Clinical Trial Manager

Research Director

Principal Investigator

Legal Counsel

Regulatory Affairs Manager

Clinical Operations Director

Research Coordinator

Medical Director

Contracts Manager

Chief Medical Officer

Ethics Committee Chair

Quality Assurance Manager

Clinical Research Associate

Study Site Manager

Compliance Officer

Research Administrator

Industries
Therapeutic Goods Act 1989: Primary federal legislation governing the regulation of therapeutic goods in Australia, including requirements for clinical trials of medicines and medical devices
Privacy Act 1988: Federal legislation governing the handling of personal information, including sensitive health data in clinical trials
National Health and Medical Research Council Act 1992: Establishes the NHMRC and provides framework for medical research governance and ethical standards
Clinical Trial Notification (CTN) Scheme: Regulatory framework under the Therapeutic Goods Administration (TGA) for conducting clinical trials in Australia
Australian Clinical Trial Handbook: TGA guidance document outlining requirements and best practices for conducting clinical trials
National Statement on Ethical Conduct in Human Research: Guidelines for ethical conduct of research involving humans, including clinical trials
Medicines Australia Code of Conduct: Industry standards for ethical conduct in pharmaceutical research and development
State-specific Health Acts: Various state-level health legislation that may impact clinical trial conduct in specific jurisdictions
Good Clinical Practice (GCP) Guidelines: International ethical and scientific quality standards for clinical trials that Australia has adopted
Research Liability Scheme Guidelines: Guidelines regarding insurance and indemnity requirements for clinical trials in Australia
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

Find the exact document you need

Clinical Trial Contract

An Australian-law governed agreement establishing the legal framework for conducting clinical trials, defining relationships and obligations between sponsors, institutions, and investigators.

find out more

Accelerated Clinical Trial Agreement

An Australian-law governed agreement for expedited implementation of clinical trials, incorporating standardized terms and accelerated approval processes while maintaining regulatory compliance.

find out more

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