Clinical Research Agreements are essential documents in Singapore's medical research landscape, used when organizations wish to conduct clinical trials or research studies. These agreements, governed by Singapore law, establish the framework for conducting research while ensuring compliance with local regulations and international standards. A Clinical Research Agreement typically covers crucial aspects such as protocol adherence, subject protection, data handling, financial terms, and intellectual property rights. It's particularly important in Singapore due to the country's strict regulatory environment and its position as a leading biomedical research hub in Asia.
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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 cancer drug, where our pharmaceutical company will sponsor research at Singapore General Hospital, with a planned start date of March 2025 and estimated 24-month duration."
1. Parties: Identification of contracting parties (typically sponsor, institution, and principal investigator)
2. Background: Context of the clinical research and purpose of the agreement
3. Definitions: Key terms used throughout the agreement including regulatory references to Singapore legislation
4. Scope of Services: Detailed description of the clinical trial and responsibilities of each party
5. Protocol Compliance: Requirements for adherence to approved protocol and SG-GCP guidelines
6. Regulatory Compliance: Compliance with Singapore laws including Medicines Act, Health Products Act, and Human Biomedical Research Act
7. Data Protection: Handling of subject data and compliance with Singapore Personal Data Protection Act
8. Safety Reporting: Requirements for adverse event reporting and safety monitoring
9. Confidentiality: Protection of confidential information and trade secrets
10. Intellectual Property: Ownership and rights to research results, innovations, and study data
11. Payment Terms: Financial arrangements, payment schedule, and study costs
12. Indemnification: Liability provisions and indemnification obligations
13. Term and Termination: Duration, renewal, and termination provisions
14. General Provisions: Standard boilerplate clauses including governing law (Singapore), dispute resolution, and notices
1. Equipment Provision: Terms for provision, maintenance, and return of sponsor-provided equipment
2. Study Drug Supply: Terms for handling, storage, and accountability of study medication
3. Publication Rights: Terms for publishing study results and academic use of data
4. Sub-contracting: Terms for engaging third parties and delegation of study responsibilities
5. Research Staff: Specific provisions regarding research staff qualifications and training
1. Protocol: Detailed clinical trial protocol approved by relevant authorities
2. Budget and Payment Schedule: Detailed financial terms, payment milestones, and cost breakdown
3. Insurance Certificates: Clinical trial insurance documentation and coverage details
4. Data Protection Requirements: Specific data handling procedures compliant with Singapore PDPA
5. Form of Patient Consent: Template informed consent forms approved by IRB
6. Required Approvals: IRB approvals, HSA permissions, and other regulatory authorizations
7. Study Team Details: List of approved investigators and research staff
8. Reporting Templates: Standard forms for safety reporting and study documentation
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