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Clinical Study Agreement

Clinical Study Agreement Template for Malaysia

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Key Requirements PROMPT example:

Clinical Study Agreement

"I need a Clinical Study Agreement for a Phase III diabetes drug trial to be conducted at Hospital Kuala Lumpur, with a Contract Research Organization managing the study starting March 2025; the agreement should include specific provisions for biological sample handling and international data transfers."

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Document background
The Clinical Study Agreement serves as the primary contractual document for establishing and governing clinical trials in Malaysia. It is essential when a pharmaceutical company, research institution, or medical device manufacturer intends to conduct clinical research involving human subjects in Malaysian healthcare facilities. The agreement must comply with Malaysian regulatory requirements, including the Medical Act 1971, PDPA 2010, and NPRA guidelines. It details crucial elements such as study protocol implementation, participant safety measures, data handling procedures, financial terms, and risk allocation between parties. This document is particularly important given Malaysia's growing role in international clinical research and its strict regulatory framework for protecting patient interests while advancing medical research.
Suggested Sections

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

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

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

4. Study Conduct: Core obligations regarding study conduct, compliance with protocol, and GCP guidelines

5. Investigator Responsibilities: Specific duties and commitments of the principal investigator

6. Institution Responsibilities: Obligations of the institution hosting the clinical trial

7. Sponsor Responsibilities: Duties and commitments of the study sponsor

8. Regulatory Compliance: Compliance with laws, regulations, and ethical requirements

9. Subject Recruitment and Informed Consent: Requirements for participant recruitment and consent processes

10. Study Drug/Device Management: Handling, storage, and accountability of study materials

11. Safety Reporting: Procedures for adverse event reporting and safety monitoring

12. Financial Arrangements: Payment terms, schedule, and financial obligations

13. Confidentiality: Protection and handling of confidential information

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

15. Publications and Publicity: Rules for publishing study results and making public statements

16. Insurance and Indemnification: Liability coverage and indemnification obligations

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

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

Optional Sections

1. CRO Provisions: Required when a Contract Research Organization is involved in study management

2. Multi-Center Provisions: Needed for studies conducted across multiple institutions

3. Equipment Provision: Required when sponsor provides specific equipment for the study

4. Third Party Laboratory Services: Needed when external laboratory services are part of the study

5. Biological Samples: Required when study involves collection and storage of biological samples

6. Data Protection: Enhanced data protection provisions for studies involving sensitive personal data

7. Translation Requirements: Needed when study materials require translation to local languages

8. Sub-investigator Obligations: Required when multiple investigators are involved

9. Quality Assurance: Enhanced quality control provisions for complex studies

Suggested Schedules

1. Schedule 1 - Protocol: Detailed clinical trial protocol including all amendments

2. Schedule 2 - Budget and Payment Schedule: Detailed financial terms, payment breakdown, and timeline

3. Schedule 3 - Study Timeline: Key milestone dates and study duration details

4. Schedule 4 - Material Transfer Terms: Terms for handling study drug/device and other materials

5. Schedule 5 - Insurance Certificates: Copies of relevant insurance policies and certificates

6. Schedule 6 - Form of Informed Consent: Approved informed consent form template

7. Schedule 7 - Data Protection Requirements: Specific data protection and privacy procedures

8. Schedule 8 - Study Team Members: List of approved investigators and study team members

9. Schedule 9 - Required Reports and Documentation: Templates and requirements for study documentation

10. Appendix A - Regulatory Approvals: Copies of ethics committee and regulatory authority 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

Linkedin in social icon imageX social icon image
alex.den.21@genieai.co
Relevant legal definitions
Adverse Event
Agreement
Background Intellectual Property
Clinical Trial
Confidential Information
Contract Research Organization
Data Protection Laws
Effective Date
Ethics Committee
Good Clinical Practice
Institution
Intellectual Property Rights
Investigation Site
Investigational Product
Medical Records
NPRA
Patient
Personal Data
Principal Investigator
Protocol
Regulatory Authority
Research Staff
Serious Adverse Event
Sponsor
Study
Study Completion Date
Study Data
Study Drug
Study Materials
Study Subject
Study Team
Sub-Investigator
Trial Documentation
Trial Results
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Life Sciences

Medical Education

Contract Research Services

Healthcare Consulting

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research and Development

Medical Affairs

Clinical Research

Compliance

Quality Assurance

Data Management

Contract Management

Ethics Committee

Site Management

Patient Safety

Clinical Documentation

Relevant Roles

Clinical Research Director

Medical Director

Principal Investigator

Research Coordinator

Legal Counsel

Regulatory Affairs Manager

Clinical Operations Manager

Chief Medical Officer

Research Ethics Committee Member

Contract Manager

Study Site Manager

Clinical Trial Administrator

Quality Assurance Manager

Data Protection Officer

Clinical Research Associate

Healthcare Facility Administrator

Industries
Medical Act 1971: Governs medical practice and practitioners in Malaysia, including their involvement in clinical trials and research studies
Personal Data Protection Act 2010: Regulates the collection, use, and disclosure of personal data, particularly important for patient information in clinical trials
Medicines (Advertisement and Sale) Act 1956: Controls the advertising and sale of medicines and medical products, relevant for clinical trial materials
Poisons Act 1952: Regulates the importation, possession, manufacture, and sale of poisons and pharmaceuticals used in clinical trials
Malaysian Guideline for Good Clinical Practice (GCP): Provides standards for conducting clinical trials in Malaysia, based on ICH-GCP guidelines
National Pharmaceutical Regulatory Agency (NPRA) Guidelines: Specific guidelines for clinical trial conduct, including Clinical Trial Import License (CTIL) requirements
Medical Device Act 2012: Relevant if the clinical study involves medical devices, regulating their use and testing
Guidelines for Application of Clinical Trial Import License and Clinical Trial Exemption: Specific requirements for importing and using investigational products in clinical trials
Malaysian Code of Conduct for Clinical Research (MCCCR): Ethical guidelines and standards for conducting clinical research in Malaysia
Contracts Act 1950: General contract law principles applicable to all agreements in Malaysia, including clinical study agreements
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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