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Clinical Research Agreement

Clinical Research Agreement Template for Hong Kong

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Key Requirements PROMPT example:

Clinical Research Agreement

"I need a Clinical Research Agreement for a Phase II trial of a new diabetes medication, where our Hong Kong-based pharmaceutical company will collaborate with two local hospitals, with the trial scheduled to start in March 2025."

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Document background
The Clinical Research Agreement is a crucial document used when establishing a formal relationship between parties conducting clinical research in Hong Kong. It is typically employed when a pharmaceutical company, medical device manufacturer, or other sponsor wishes to conduct clinical trials or research studies through a research institution or hospital. The agreement must comply with Hong Kong's regulatory framework, including the Pharmacy and Poisons Ordinance, Personal Data (Privacy) Ordinance, and relevant healthcare regulations. It outlines critical elements such as protocol compliance, participant safety, data handling, financial terms, and intellectual property rights. This document is essential for ensuring clear accountability, risk management, and regulatory compliance while protecting all parties' interests in the research process.
Suggested Sections

1. Parties: Identification of the research institution, sponsor, and any other key parties

2. Background: Context of the research project and relationship between the parties

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

4. Scope of Research: Detailed description of the clinical research project, objectives, and methodology

5. Regulatory Compliance: Obligations regarding compliance with Hong Kong laws, regulations, and ethical guidelines

6. Study Team and Principal Investigator: Identification and responsibilities of key research personnel

7. Payment Terms: Financial arrangements, payment schedule, and research costs

8. Confidentiality: Protection of confidential information and research data

9. Data Protection: Compliance with PDPO and handling of personal data

10. Intellectual Property Rights: Ownership and licensing of research results and innovations

11. Publication Rights: Rights and procedures for publishing research results

12. Liability and Indemnification: Risk allocation and protection against claims

13. Insurance: Required insurance coverage for the research

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

15. General Provisions: Standard contractual terms including governing law, notices, and amendments

Optional Sections

1. Multi-Center Study Provisions: Additional terms for research conducted across multiple locations

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

3. Biological Samples: Handling and ownership of biological samples if applicable

4. Third Party Contractors: Terms governing use of contractors or external service providers

5. Translation Requirements: Requirements for translation of documents if involving non-English speaking participants

6. Post-Study Access: Provisions for continued access to treatment after study completion

7. Emergency Procedures: Special procedures for handling medical emergencies

8. Technology Transfer: Terms for any technology transfer requirements

Suggested Schedules

1. Research Protocol: Detailed protocol including methodology, timeline, and procedures

2. Budget and Payment Schedule: Detailed breakdown of costs and payment milestones

3. Required Approvals: List of regulatory and ethical approvals required

4. Research Team: Details of all investigators and key personnel

5. Reporting Requirements: Templates and schedules for required reports

6. Insurance Certificates: Copies of required insurance policies

7. Data Management Plan: Procedures for data collection, storage, and handling

8. Form of Informed Consent: Template for participant informed consent

9. Safety Reporting Procedures: Protocols for adverse event reporting

Authors

Alex Denne

Head of Growth (Open Source Law) @ ¶¶Òõ¶ÌÊÓƵ | 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

Life Sciences

Academic Research

Contract Research Services

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research and Development

Compliance

Data Protection

Medical Affairs

Clinical Research

Business Development

Project Management

Ethics Committee

Finance

Contracts Administration

Relevant Roles

Clinical Research Director

Legal Counsel

Chief Medical Officer

Research Principal Investigator

Clinical Operations Manager

Regulatory Affairs Manager

Contract Manager

Research Ethics Officer

Data Protection Officer

Clinical Trial Coordinator

Medical Director

Research Administrator

Compliance Officer

Business Development Manager

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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