Clinical Study Agreements are essential documents used when conducting clinical trials or research studies in Singapore. These agreements establish the legal framework for collaboration between sponsors, research institutions, and investigators while ensuring compliance with Singapore's regulatory requirements. The Clinical Study Agreement defines key aspects including protocol adherence, patient safety measures, data handling, financial terms, and intellectual property rights. It must align with Singapore's strict regulatory framework, including the Medicines Act, Health Products Act, and Human Biomedical Research Act, while meeting international research standards.
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Key Requirements PROMPT example:
Clinical Study Agreement
"I need a Clinical Study Agreement for a Phase II trial of a new cancer drug to be conducted at Singapore General Hospital, starting March 2025, with specific provisions for biological sample collection and multiple study sites across Singapore."
1. Parties: Identifies all parties to the agreement including Sponsor, Institution, Principal Investigator
2. Background: Outlines the context of the clinical study and the parties' intentions
3. Definitions: Defines key terms used throughout the agreement including Study Protocol, Confidential Information, Study Data, etc.
4. Study Protocol: Details of the approved clinical study protocol and compliance requirements including regulatory frameworks
5. Responsibilities: Detailed obligations of each party in conducting the study in accordance with Singapore regulations
6. Financial Arrangements: Payment terms, schedule, and financial obligations between parties
7. Confidentiality: Provisions regarding confidential information handling in compliance with PDPA
8. Intellectual Property: Rights and ownership of study data, results, and innovations under Singapore IP laws
9. Publication Rights: Terms for publishing study results and data with appropriate reviews
10. Term and Termination: Duration and conditions for ending the agreement
1. Equipment Provision: Terms for supplied equipment and maintenance requirements
2. Biological Samples: Handling and ownership of biological materials under HBRA requirements
3. Sub-contractor Terms: Terms for third-party service providers and their obligations
4. Multi-center Provisions: Specific terms for studies conducted across multiple sites
1. Schedule 1 - Study Protocol: Detailed protocol approved by HSA and relevant authorities
2. Schedule 2 - Budget and Payment Schedule: Detailed financial terms and payment milestones
3. Schedule 3 - Insurance Certificates: Proof of required insurance coverage for clinical trials
4. Schedule 4 - Data Protection Protocol: Specific procedures for handling personal data under PDPA
5. Schedule 5 - Study Timeline: Detailed schedule of study milestones and deadlines
6. Schedule 6 - Reporting Requirements: Templates and schedules for required reports to authorities
7. Schedule 7 - Equipment List: Inventory of provided equipment and terms of use
8. Schedule 8 - Site Requirements: Specific requirements for study site facilities and compliance
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