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.
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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
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
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: Ƶ 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
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