Investigator Agreement Template for Singapore

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Key Requirements PROMPT example:

Investigator Agreement

"I need an Investigator Agreement for a phase III clinical trial of a new cancer drug, involving multiple research sites across Singapore, with a study duration of 24 months starting March 2025, and specific provisions for handling biological samples."

Document background

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.

Suggested Sections

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

Optional Sections

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

Suggested Schedules

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

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co

Relevant legal definitions

Clauses

Relevant Industries

Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Academic Research

Relevant Teams

Clinical Research
Legal
Regulatory Affairs
Research & Development
Ethics Committee
Compliance

Relevant Roles

Principal Investigator
Clinical Research Coordinator
Research Director
Medical Director
Clinical Operations Manager
Research Compliance Officer

Industries

Medicines Act (Chapter 176): Primary legislation governing the regulation of medicines, medical devices, and clinical trials in Singapore

Health Products Act: Regulates the manufacture, import, supply, presentation and advertisement of health products in Singapore

Human Biomedical Research Act 2015: Regulates human biomedical research, ensuring ethical conduct and protecting research subjects' safety and personal information

Clinical Trials Regulations: Specific regulations governing the conduct of clinical trials, including safety monitoring and reporting requirements

Personal Data Protection Act 2012 (PDPA): Comprehensive data protection law governing collection, use, disclosure and care of personal data

Singapore Medical Council Ethical Code and Guidelines: Professional standards and ethical guidelines for medical practitioners in Singapore

Singapore Guideline for Good Clinical Practice (SG-GCP): Local adaptation of international GCP guidelines for conducting clinical trials in Singapore

Contract Law: Common law principles governing formation and enforcement of contracts in Singapore

Electronic Transactions Act: Legislation governing electronic signatures and electronic transactions

Employment Act: Main labor law governing employment relationships and working conditions

Employment of Foreign Manpower Act: Regulates employment of foreign workers and specialists in Singapore

Patents Act: Legislation governing patent rights and protection of inventions

Confidential Information Law: Common law principles protecting confidential information and trade secrets

Private Hospitals and Medical Clinics Act: Regulates private healthcare institutions and ensures quality of healthcare services

Healthcare Services Act: Updated framework for regulating healthcare services and ensuring patient safety

DSRB Guidelines: National Healthcare Group Domain Specific Review Board guidelines for research ethics review

CIRB Guidelines: Singhealth Centralised Institutional Review Board guidelines for research ethics review

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Authors

Alex Denne

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