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Clinical Trial Contract Template for Malaysia

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Key Requirements PROMPT example:

Clinical Trial Contract

"I need a Clinical Trial Contract for a Phase III diabetes drug study to be conducted at Hospital Kuala Lumpur, involving our pharmaceutical company as sponsor and potential recruitment of 200 patients starting March 2025."

Document background
The Clinical Trial Contract serves as the primary legal instrument for establishing and governing clinical research relationships in Malaysia. This document is essential when a pharmaceutical company, research institution, or medical device manufacturer plans to conduct clinical trials in Malaysia. The agreement must comply with Malaysian regulatory requirements, including those set by the National Pharmaceutical Regulatory Agency (NPRA) and the Ministry of Health. It details the complete framework for trial conduct, including protocol implementation, participant safety, data management, financial terms, and regulatory compliance. The contract addresses specific Malaysian legal requirements while incorporating international best practices in clinical research, making it suitable for both local and international sponsors conducting trials in Malaysian healthcare facilities.
Suggested Sections

1. Parties: Identification of all contracting parties including sponsor, research institution, principal investigator, and any relevant third parties

2. Background: Context of the clinical trial, including the study drug/device and purpose of the research

3. Definitions: Detailed definitions of technical terms, regulatory references, and contract-specific terminology

4. Scope of Services: Detailed description of the clinical trial, including protocol reference and key objectives

5. Regulatory Compliance: Compliance requirements with Malaysian regulations, GCP, and other applicable laws

6. Trial Governance: Management structure, roles, and responsibilities of all parties

7. Financial Provisions: Payment terms, budget, and financial responsibilities

8. Confidentiality: Protection of confidential information and trade secrets

9. Intellectual Property: Ownership and rights to trial data, inventions, and publications

10. Data Protection: Compliance with PDPA 2010 and data handling requirements

11. Insurance and Indemnification: Insurance requirements and indemnification provisions

12. Term and Termination: Duration of agreement and termination provisions

13. General Provisions: Standard contractual terms including governing law, notices, and amendments

Optional Sections

1. Subject Injury: Specific provisions for handling and compensating trial-related injuries, used when not covered in insurance section

2. Equipment and Supplies: Terms for provision and maintenance of trial-specific equipment, used when sponsor provides equipment

3. Sub-contracting: Terms for engaging third-party service providers, used when sub-contractors are anticipated

4. Publication Rights: Detailed publication procedures and restrictions, used when academic institutions are involved

5. Biological Samples: Handling and ownership of biological samples, used when trial involves sample collection

6. Technology Transfer: Terms for any technology or know-how transfer, used when relevant to the trial

7. Force Majeure: Provisions for unexpected events affecting trial conduct, used when specifically requested

Suggested Schedules

1. Schedule 1 - Protocol: Complete trial protocol or protocol summary

2. Schedule 2 - Budget and Payment Schedule: Detailed budget breakdown and payment milestones

3. Schedule 3 - Timeline: Trial timeline including key milestones and deliverables

4. Schedule 4 - Personnel: Key personnel and their responsibilities

5. Schedule 5 - Required Documents: List of essential documents required for trial conduct

6. Schedule 6 - Insurance Certificates: Copies of relevant insurance policies

7. Schedule 7 - Data Management Plan: Detailed procedures for data collection, storage, and handling

8. Appendix A - Monitoring Requirements: Specific monitoring procedures and requirements

9. Appendix B - Safety Reporting Procedures: Procedures for adverse event reporting and safety monitoring

10. Appendix C - Quality Management Plan: Quality assurance and control procedures

Authors

Alex Denne

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

Relevant legal definitions







































Clauses
































Relevant Industries

Pharmaceuticals

Healthcare

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Life Sciences

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research & Development

Medical Affairs

Quality Assurance

Clinical Research

Compliance

Contract Management

Ethics Committee

Relevant Roles

Clinical Research Director

Legal Counsel

Regulatory Affairs Manager

Principal Investigator

Clinical Operations Manager

Research Coordinator

Medical Director

Contract Manager

Compliance Officer

Quality Assurance Manager

Clinical Trial Manager

Chief Medical Officer

Research Ethics Committee Member

Site Manager

Clinical Research Associate

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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