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Clinical Research Agreement

Clinical Research Agreement Template for Malaysia

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Key Requirements PROMPT example:

Clinical Research Agreement

"I need a Clinical Research Agreement for a Phase III diabetes drug trial to be conducted at three Malaysian hospitals, starting March 2025, with specific provisions for biological sample storage and handling of genetic data."

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Document background
The Clinical Research Agreement serves as the primary legal instrument for establishing and governing clinical trial relationships in Malaysia. This document is essential when pharmaceutical companies, biotechnology firms, or research organizations wish to conduct clinical trials in Malaysian healthcare facilities or research institutions. The agreement ensures compliance with Malaysian regulations, including the requirements of the National Pharmaceutical Regulatory Agency (NPRA), Personal Data Protection Act 2010, and relevant healthcare laws. It comprehensively addresses critical aspects such as trial protocol implementation, participant safety, data protection, intellectual property rights, financial arrangements, and regulatory compliance. The Clinical Research Agreement is specifically designed to meet Malaysian legal requirements while incorporating international best practices in clinical research.
Suggested Sections

1. Parties: Identification of all contracting parties including Sponsor, Research Institution, and Principal Investigator

2. Background: Context of the clinical trial and purpose of the agreement

3. Definitions: Detailed definitions of terms used throughout the agreement

4. Scope of Services: Detailed description of the clinical trial and services to be performed

5. Regulatory Compliance: Obligations regarding compliance with Malaysian laws, ICH-GCP, and other applicable regulations

6. Trial Governance: Protocol adherence, ethics committee approval, and trial management requirements

7. Responsibilities of Parties: Specific duties of each party in conducting the clinical trial

8. Financial Arrangements: Payment terms, schedule, and financial responsibilities

9. Confidentiality: Provisions for protecting confidential information and trial data

10. Intellectual Property: Ownership and rights to study data, inventions, and publications

11. Data Protection: Compliance with PDPA 2010 and handling of personal/medical data

12. Publication Rights: Terms for publishing study results and academic publications

13. Insurance and Indemnification: Insurance requirements and indemnification provisions

14. Term and Termination: Duration of agreement and termination conditions

15. General Provisions: Standard legal provisions including governing law, dispute resolution, and notices

Optional Sections

1. Multi-Center Trial Provisions: Additional terms for trials conducted across multiple sites

2. Equipment and Supplies: Terms for provision and use of specific equipment or supplies

3. Biological Samples: Handling, storage, and transfer of biological materials

4. Third Party Contractors: Terms governing use of CROs or other contractors

5. Subject Injury Provisions: Specific provisions for handling trial-related injuries

6. Post-Trial Access: Terms for continued access to study medication after trial completion

7. Translation Requirements: Provisions for translation of documents in multi-language trials

Suggested Schedules

1. Schedule 1 - Protocol: Detailed clinical trial protocol

2. Schedule 2 - Budget and Payment Schedule: Detailed financial terms and payment milestones

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

4. Schedule 4 - Insurance Certificates: Copies of required insurance documentation

5. Schedule 5 - Form of Informed Consent: Approved informed consent template

6. Schedule 6 - Data Protection Requirements: Detailed data protection and privacy requirements

7. Schedule 7 - Required Reports: List and templates of required trial reports

8. Appendix A - Key Personnel: List of key trial personnel and their responsibilities

9. Appendix B - Equipment List: Detailed list of supplied equipment and terms of use

10. Appendix C - Quality Requirements: Specific quality control and assurance requirements

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

alex.den.21@genieai.co
Relevant legal definitions










































Clauses


































Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Research

Clinical Trials

Healthcare Technology

Medical Devices

Academic Research

Contract Research

Relevant Teams

Legal

Clinical Operations

Medical Affairs

Regulatory Affairs

Research & Development

Compliance

Quality Assurance

Data Management

Contract Administration

Clinical Research

Ethics & Governance

Site Operations

Relevant Roles

Clinical Research Director

Medical Director

Legal Counsel

Regulatory Affairs Manager

Clinical Trial Manager

Principal Investigator

Research Coordinator

Compliance Officer

Contract Manager

Medical Affairs Manager

Clinical Operations Manager

Research Ethics Officer

Data Protection Officer

Quality Assurance Manager

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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