The Investigator Agreement serves as a critical document in Singapore's research landscape, establishing the legal and operational framework for clinical trials and research studies. This agreement is essential when engaging investigators to conduct research, particularly in clinical trials, medical device testing, or biomedical research. It addresses key aspects such as compliance with Singapore's regulatory requirements, data protection, intellectual property rights, and ethical guidelines. The agreement ensures all parties understand their roles, responsibilities, and obligations while maintaining compliance with local laws and international research standards.
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1. Parties: Identifies the contracting parties: typically the sponsor/institution and the investigator
2. Background: Explains the context of the research study and the purpose of the agreement
3. Definitions: Defines key terms used throughout the agreement
4. Scope of Services: Details the investigator's responsibilities and the research to be conducted
5. Compliance with Laws and Regulations: Obligations to comply with relevant laws, regulations, and guidelines
6. Data Protection and Confidentiality: Requirements for handling personal data and confidential information
7. Intellectual Property Rights: Ownership and rights related to study results and innovations
8. Payment Terms: Compensation structure and payment schedule
9. Term and Termination: Duration of agreement and termination conditions
1. Insurance and Indemnification: Coverage and liability provisions - used when specific insurance requirements exist or liability allocation needs clarification
2. Publication Rights: Terms for publishing study results - used when academic or research publication is anticipated
3. Equipment and Materials: Provisions for study equipment and materials - used when specific equipment or materials are provided for the study
4. Sub-investigator Provisions: Terms relating to additional investigators - used when sub-investigators will be involved
1. Protocol: Detailed research protocol and methodology
2. Budget Schedule: Detailed breakdown of payments and costs
3. Timeline: Study milestones and deadlines
4. Data Protection Protocol: Specific procedures for data handling and protection
5. Reporting Templates: Standard forms for progress and safety reporting
6. Required Certifications: Copies of relevant certifications and approvals
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