Clinical Trial Agreements are essential documents used when conducting medical research involving human subjects in Singapore. These agreements establish the framework for collaboration between sponsors, institutions, and investigators while ensuring compliance with Singapore's stringent regulatory requirements. The Clinical Trial Agreement defines roles, responsibilities, and obligations of all parties, covering crucial aspects such as regulatory approvals, patient safety, data protection, and financial terms. It must align with Singapore's Health Sciences Authority (HSA) guidelines, Good Clinical Practice standards, and relevant healthcare legislation.
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1. Parties: Identification of all contracting parties including Sponsor, Institution, Principal Investigator
2. Background: Context of the clinical trial, purpose of the agreement, and reference to the study protocol
3. Definitions: Key terms used tHRoughout the agreement including Study, Protocol, Study Drug, Study Data, etc.
4. Study Conduct: Requirements for conducting the clinical trial in accordance with Protocol, GCP, and applicable laws
5. Regulatory Compliance: Obligations regarding HSA approvals, ethics committee approvals, and regulatory reporting
6. Data Protection and Confidentiality: PDPA compliance, data handling, and confidentiality obligations
7. Intellectual Property: Ownership and rights to study data, inventions, and publications
8. Payment Terms: Financial arrangements, payment schedule, and costs coverage
9. Term and Termination: Duration of agreement and termination provisions
1. Equipment Provision: Terms for equipment supplied by sponsor when specific equipment is provided for the trial
2. Biological Samples: Handling and rights regarding biological samples when trial involves collection of biological materials
3. Sub-contractor Terms: Requirements for third-party service providers when parts of the trial are outsourced
1. Protocol: Detailed clinical trial protocol
2. Budget and Payment Schedule: Detailed breakdown of costs and payment timelines
3. Insurance Certificates: Clinical trial insurance documentation
4. Form of Ethics Committee Approval: Template or actual ethics committee approval
5. Data Protection Requirements: Specific data handling and protection procedures
6. Safety Reporting Procedures: Procedures for reporting adverse events
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Clinical Trial Agreement
A legal agreement governing clinical trials in Singapore, ensuring compliance with local healthcare laws and HSA regulations.
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