The Clinical Trial Confidentiality Agreement is essential for protecting sensitive information in medical research conducted in Hong Kong. It should be used whenever parties engage in clinical trials or related research activities where confidential information needs to be shared. The agreement ensures compliance with Hong Kong's Personal Data (Privacy) Ordinance, medical research regulations, and international clinical trial standards. It covers various types of confidential information including trial protocols, patient data, research methodologies, and preliminary results. This document is particularly important given Hong Kong's position as a major medical research hub and its strict data protection requirements. The agreement includes specific provisions for data handling, security measures, and permitted disclosures while addressing both local and international compliance requirements.
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1. Parties: Identification of the disclosing party (typically the research institution/sponsor) and receiving party (typically the researcher/medical professional/contractor)
2. Background: Context of the clinical trial and purpose of the confidentiality agreement
3. Definitions: Detailed definitions including 'Confidential Information', 'Clinical Trial', 'Trial Data', 'Study Protocol', and other key terms
4. Scope of Confidential Information: Detailed description of what constitutes confidential information in the context of the clinical trial
5. Obligations of Confidentiality: Core confidentiality obligations, including handling, storage, and protection of trial data and confidential information
6. Permitted Disclosures: Circumstances under which confidential information may be disclosed, including regulatory requirements and medical emergencies
7. Data Protection and Security: Specific measures required for protecting personal data and trial information in compliance with Hong Kong law
8. Term and Survival: Duration of confidentiality obligations and survival of obligations post-termination
9. Return or Destruction of Confidential Information: Requirements for handling confidential information upon termination or completion
10. Breach and Remedies: Consequences of breach and available remedies
11. General Provisions: Standard clauses including governing law, jurisdiction, and entire agreement
1. Publication Rights: Terms governing the publication of trial results and academic findings - include when academic institutions are involved
2. Intellectual Property Rights: Specific IP provisions related to trial discoveries - include when new IP might be generated
3. Third Party Disclosure: Provisions for sharing information with subcontractors or other necessary third parties - include when multiple parties are involved
4. International Data Transfer: Provisions for cross-border data transfer - include when data will be transferred outside Hong Kong
5. Insurance and Liability: Additional protection clauses - include when high-risk trials are involved
6. Regulatory Compliance: Specific regulatory requirements - include when dealing with regulated products or substances
1. Schedule 1 - Description of Clinical Trial: Detailed description of the trial, including protocol number and study objectives
2. Schedule 2 - Specific Categories of Confidential Information: Detailed list of types of confidential information covered
3. Schedule 3 - Authorized Personnel: List of authorized individuals who will have access to confidential information
4. Schedule 4 - Security Protocols: Specific security measures and protocols for handling confidential information
5. Appendix A - Data Protection Requirements: Detailed data protection and handling requirements under Hong Kong law
6. Appendix B - Form of Confidentiality Undertaking: Template for individual confidentiality undertakings by team members
Relevant legal definitions
Clauses
Relevant Industries
Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Clinical Research
Life Sciences
Healthcare Technology
Academic Research
Contract Research
Medical Testing
Drug Development
Medical Innovation
Relevant Teams
Legal
Clinical Operations
Research and Development
Regulatory Affairs
Data Protection
Clinical Research
Quality Assurance
Compliance
Medical Affairs
Research Ethics
Clinical Data Management
Study Management
Trial Operations
Relevant Roles
Clinical Trial Manager
Research Director
Principal Investigator
Clinical Research Coordinator
Medical Director
Research Scientist
Regulatory Affairs Manager
Data Protection Officer
Clinical Operations Manager
Research Ethics Committee Member
Legal Counsel
Compliance Officer
Medical Officer
Research Administrator
Clinical Research Associate
Study Monitor
Biostatistician
Quality Assurance Manager
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