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.
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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
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
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
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.
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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.
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