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Investigator Agreement Template for Malaysia

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Key Requirements PROMPT example:

Investigator Agreement

"I need an Investigator Agreement for a Phase III clinical trial of a new diabetes medication, to be conducted at three hospitals in Kuala Lumpur, with specific provisions for handling biological samples and remote monitoring requirements."

Document background
The Investigator Agreement serves as the primary contract governing the relationship between research sponsors/institutions and medical investigators conducting clinical trials in Malaysia. This document is essential when engaging qualified medical professionals to conduct clinical research, ensuring compliance with Malaysian regulatory requirements, including the Clinical Trial Regulation 2018 and Malaysian Guidelines for Good Clinical Practice. The agreement comprehensively addresses key aspects such as protocol adherence, patient safety, data collection, confidentiality, and compensation, while incorporating specific Malaysian legal and regulatory requirements. It's particularly crucial for pharmaceutical companies, research organizations, and healthcare institutions conducting clinical trials in Malaysia, providing a clear framework for responsibilities, obligations, and compliance requirements.
Suggested Sections

1. Parties: Identifies the contracting parties: typically the sponsor/institution and the investigator

2. Background: Contextual information about the study and the purpose of the agreement

3. Definitions: Defines key terms used throughout the agreement

4. Scope of Services: Details the investigator's roles, responsibilities, and services to be provided

5. Compliance with Laws and Regulations: Requirements for compliance with Malaysian laws, GCP, and other applicable regulations

6. Study Protocol: Requirements for adherence to the study protocol and procedures for amendments

7. Patient Recruitment and Informed Consent: Guidelines for participant recruitment and obtaining informed consent

8. Data Collection and Reporting: Requirements for data collection, documentation, and reporting obligations

9. Confidentiality: Obligations regarding confidential information and study data

10. Intellectual Property: Rights and obligations regarding study-related intellectual property

11. Publication Rights: Terms governing the publication of study results

12. Compensation and Payment: Payment terms, schedule, and conditions

13. Term and Termination: Duration of the agreement and conditions for termination

14. Insurance and Indemnification: Insurance requirements and indemnification provisions

15. Governing Law and Jurisdiction: Specifies Malaysian law as governing law and jurisdiction for disputes

16. General Provisions: Standard contractual provisions including notices, amendments, and assignment

Optional Sections

1. Sub-Investigator Obligations: Required when sub-investigators will be involved in the study

2. Equipment and Supplies: Include when specific equipment or supplies are provided for the study

3. Biological Samples: Required when the study involves collection and handling of biological samples

4. Study Drug Management: Include for studies involving investigational medicinal products

5. Remote Monitoring Provisions: Include when remote monitoring of study activities is required

6. Translation Requirements: Include when study materials require translation to local languages

7. Safety Reporting: Detailed section required for high-risk studies or when handling specific safety concerns

8. Archive and Record Retention: Extended provisions when specific archiving requirements exist

Suggested Schedules

1. Schedule 1 - Study Protocol: Detailed protocol for the clinical study

2. Schedule 2 - Payment Schedule: Detailed breakdown of payment amounts, timing, and conditions

3. Schedule 3 - Timeline and Milestones: Key dates and deliverables for the study

4. Schedule 4 - Required Documentation: List of essential documents required for study conduct

5. Schedule 5 - Data Protection Requirements: Specific requirements for handling personal data under Malaysian law

6. Appendix A - Investigator's CV: Principal Investigator's curriculum vitae and qualifications

7. Appendix B - Facility Requirements: Specifications for facility and equipment requirements

8. Appendix C - Study Team Members: List of approved study team members and their roles

Authors

Alex Denne

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

Relevant legal definitions


































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Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Academic Research

Healthcare Technology

Life Sciences

Relevant Teams

Legal

Clinical Operations

Medical Affairs

Regulatory Affairs

Research & Development

Clinical Research

Compliance

Contract Management

Medical Writing

Research Ethics

Relevant Roles

Clinical Research Director

Principal Investigator

Medical Director

Clinical Trial Manager

Research Coordinator

Legal Counsel

Regulatory Affairs Manager

Clinical Operations Manager

Medical Officer

Research Compliance Officer

Contract Manager

Study Manager

Chief Medical Officer

Research Ethics Officer

Industries








Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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