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Accelerated Clinical Trial Agreement

Accelerated Clinical Trial Agreement Template for Hong Kong

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Key Requirements PROMPT example:

Accelerated Clinical Trial Agreement

"I need an Accelerated Clinical Trial Agreement for a Phase II cancer drug trial to be conducted at three Hong Kong hospitals starting March 2025, with specific provisions for biological sample collection and expedited safety reporting requirements."

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Document background
The Accelerated Clinical Trial Agreement is essential for situations requiring expedited clinical research while maintaining compliance with Hong Kong regulatory requirements. This document is particularly relevant for breakthrough therapies, urgent public health needs, or innovative treatments requiring rapid clinical validation. It provides a structured framework for accelerated trials while ensuring adherence to Hong Kong's Pharmacy and Poisons Ordinance, ICH-GCP guidelines, and Hospital Authority requirements. The agreement includes specialized provisions for expedited timelines, enhanced safety monitoring, rapid data analysis, and emergency procedures, while maintaining the highest standards of patient safety and data integrity. It's designed to balance the need for speed with regulatory compliance, risk management, and ethical considerations in the Hong Kong healthcare context.
Suggested Sections

1. Parties: Identification of contracting parties including sponsor, institution, and principal investigator

2. Background: Context of the accelerated clinical trial, including the medical product/treatment being tested and reason for acceleration

3. Definitions: Detailed definitions of technical, medical, and legal terms used throughout the agreement

4. Scope of Trial: Detailed description of the trial, including objectives, protocol reference, and accelerated timeline requirements

5. Regulatory Compliance: Obligations regarding compliance with Hong Kong regulations, ICH-GCP guidelines, and ethics committee approvals

6. Trial Governance: Structure for trial oversight, including accelerated decision-making processes and emergency procedures

7. Responsibilities of Parties: Detailed obligations of sponsor, institution, and principal investigator, including expedited requirements

8. Patient Recruitment and Management: Processes for accelerated patient recruitment, consent, and management

9. Safety Reporting: Requirements for adverse event reporting and safety monitoring with expedited timelines

10. Data Management and Protection: Protocols for handling trial data, ensuring compliance with Hong Kong privacy laws

11. Trial Materials and Medication: Management of trial materials, including supply chain and storage requirements

12. Financial Arrangements: Payment terms, costs, and financial responsibilities of parties

13. Confidentiality: Protection of confidential information and trade secrets

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

15. Publication Rights: Terms for publishing trial results and academic use of data

16. Insurance and Indemnification: Coverage requirements and allocation of risks

17. Term and Termination: Duration, renewal, and termination provisions including expedited trial completion scenarios

18. Force Majeure: Provisions for unforeseen circumstances affecting trial conduct

19. Governing Law and Dispute Resolution: Hong Kong law governance and dispute resolution procedures

20. General Provisions: Standard boilerplate clauses including notices, amendments, and assignments

Optional Sections

1. Emergency Procedures: Additional procedures for emergency situations, required if trial involves high-risk treatments

2. Subcontractor Management: Include if third-party contractors will be involved in trial conduct

3. Multi-Center Trial Provisions: Required if trial is conducted across multiple institutions

4. Biological Sample Management: Include if trial involves collection and storage of biological samples

5. Translation Requirements: Include if trial materials require Chinese/English translations

6. Technology Transfer: Include if trial involves new technology or specialized equipment

7. Post-Trial Access: Terms for providing treatment access after trial completion, if applicable

8. Compassionate Use Provisions: Include if early access might be granted to non-trial participants

9. Local Regulatory Requirements: Specific provisions for Hong Kong Hospital Authority requirements if trial conducted in public hospitals

Suggested Schedules

1. Schedule 1: Trial Protocol: Detailed protocol including accelerated timeline specifications

2. Schedule 2: Budget and Payment Schedule: Detailed financial terms and payment milestones

3. Schedule 3: Patient Information and Consent Forms: Approved forms in required languages

4. Schedule 4: Reporting Templates: Standard forms for safety and progress reporting

5. Schedule 5: Key Personnel: List of key trial team members and their responsibilities

6. Schedule 6: Insurance Certificates: Copies of required insurance documentation

7. Schedule 7: Data Management Plan: Detailed procedures for data collection and management

8. Schedule 8: Quality Management Plan: Procedures for maintaining trial quality under accelerated timeline

9. Appendix A: Regulatory Approvals: Copies of ethics committee and regulatory authority approvals

10. Appendix B: Material Transfer Procedures: Protocols for handling trial medications and materials

11. Appendix C: Safety Reporting Procedures: Detailed procedures for adverse event reporting

Authors

Alex Denne

Head of Growth (Open Source Law) @ ºÚÁÏÊÓƵ | 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

Pharmaceuticals

Healthcare

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Life Sciences

Contract Research Services

Medical Laboratory Services

Healthcare Data Management

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Medical Affairs

Research and Development

Quality Assurance

Data Management

Clinical Research

Compliance

Contract Management

Ethics Committee

Project Management

Site Operations

Patient Safety

Clinical Development

Relevant Roles

Clinical Research Director

Medical Director

Principal Investigator

Research Coordinator

Legal Counsel

Regulatory Affairs Manager

Chief Medical Officer

Clinical Operations Manager

Data Protection Officer

Quality Assurance Manager

Clinical Trial Manager

Research Ethics Officer

Contract Manager

Medical Affairs Director

Compliance Officer

Site Manager

Chief Scientific Officer

Research Administrator

Clinical Development Director

Project 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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