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Clinical Study Agreement

Clinical Study Agreement Template for Philippines

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Key Requirements PROMPT example:

Clinical Study Agreement

"I need a Clinical Study Agreement under Philippine law for a Phase III diabetes drug trial to be conducted at three hospital sites in Manila, with a foreign pharmaceutical company as sponsor and expected start date of March 2025."

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Document background
The Clinical Study Agreement serves as the primary legal framework for conducting clinical trials in the Philippines, establishing the rights and obligations of all parties involved in the research process. This document is essential when a pharmaceutical company, research organization, or medical institution plans to conduct clinical research involving human subjects in the Philippines. It must comply with Philippine FDA regulations, the Data Privacy Act of 2012, and other relevant local healthcare laws while incorporating international clinical research standards. The agreement covers critical aspects including study protocol implementation, participant protection, data handling, financial terms, and regulatory compliance. It's particularly important for ensuring proper documentation of responsibilities, risk management, and compliance with Philippine Good Clinical Practice guidelines.
Suggested Sections

1. Parties: Identification of the contracting parties including Sponsor, Institution, Principal Investigator, and any relevant third parties

2. Background: Context of the clinical study, purpose of the agreement, and brief overview of the trial

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

4. Scope of Work: Detailed description of the clinical trial, including objectives, protocol compliance requirements, and responsibilities

5. Regulatory Compliance: Requirements for compliance with local laws, regulations, and ethical guidelines including FDA and DOH requirements

6. Study Timeline: Start date, duration, completion criteria, and key milestones of the study

7. Financial Arrangements: Payment terms, schedule, budget details, and cost coverage

8. Confidentiality: Provisions for protecting confidential information and trade secrets

9. Data Protection and Privacy: Compliance with data privacy laws and handling of subject information

10. Intellectual Property Rights: Ownership and rights to study data, results, and innovations

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

12. Indemnification: Liability coverage and protection for various parties

13. Insurance: Required insurance coverage and responsibilities

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

15. General Provisions: Standard legal clauses including governing law, dispute resolution, and amendments

Optional Sections

1. Multi-Center Study Provisions: Additional terms for studies conducted across multiple sites

2. Sub-Investigator Requirements: Specific provisions when additional investigators are involved

3. Equipment and Materials: Terms for provision and handling of study-specific equipment

4. Biological Samples: Provisions for collection, storage, and transfer of biological materials

5. Third-Party Vendor Management: Terms for managing external service providers

6. Foreign Sponsor Requirements: Additional provisions for international sponsors

7. Post-Study Drug Access: Terms for continued drug access after study completion

8. Conflict Resolution Committee: Establishment of a committee for handling disputes

9. Force Majeure: Provisions for handling unforeseen circumstances

10. Language Requirements: Provisions for translation and language requirements

Suggested Schedules

1. Schedule A - Protocol: Detailed clinical trial protocol

2. Schedule B - Budget and Payment Schedule: Detailed financial terms, payment milestones, and budget breakdown

3. Schedule C - Timeline: Detailed study timeline and milestones

4. Schedule D - Required Reports: List and templates of required study reports

5. Schedule E - Insurance Certificates: Copies of required insurance documentation

6. Schedule F - Data Protection Protocol: Detailed procedures for data handling and protection

7. Appendix 1 - Site Requirements: Specific requirements for study site facilities and personnel

8. Appendix 2 - Safety Reporting Procedures: Procedures for adverse event reporting and safety monitoring

9. Appendix 3 - Quality Assurance Requirements: Quality control and assurance procedures

10. Appendix 4 - Form of Informed Consent: Template and requirements for participant informed consent

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
Applicable Law
Approved Protocol
Background Intellectual Property
Biologic Sample
Case Report Form
Clinical Trial
Confidential Information
Contract Research Organization
Data Protection Laws
Effective Date
Ethics Committee
FDA
Force Majeure
Good Clinical Practice
Human Subject
ICH Guidelines
Informed Consent Form
Institution
Intellectual Property Rights
Investigational Product
Investigator Brochure
Medical Records
Monitor
Multi-Center Study
Patient
Personal Data
Philippine FDA
Principal Investigator
Protocol
Quality Assurance
Regulatory Authority
Research Staff
Serious Adverse Event
Site
Source Documents
Sponsor
Study
Study Completion
Study Data
Study Materials
Study Product
Study Results
Study Site
Study Subject
Study Timeline
Sub-Investigator
Subject
Term
Territory
Trial Master File
Clauses
Regulatory Compliance
Protocol Adherence
Study Conduct
Site Obligations
Investigator Obligations
Sponsor Obligations
Patient Safety
Data Protection
Confidentiality
Intellectual Property
Publication Rights
Financial Terms
Payment Terms
Record Keeping
Monitoring Rights
Quality Assurance
Ethics Committee Approval
Informed Consent
Subject Recruitment
Insurance and Indemnification
Liability
Force Majeure
Term and Termination
Dispute Resolution
Governing Law
Assignment
Amendment
Notices
Entire Agreement
Severability
Representation and Warranties
Study Material Handling
Safety Reporting
Adverse Event Reporting
Site Access
Documentation Requirements
Personnel Requirements
Audit Rights
Publication and Publicity
Conflict of Interest
Anti-Corruption
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Research

Clinical Research

Healthcare Technology

Life Sciences

Medical Devices

Contract Research

Academic Research

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research and Development

Medical Affairs

Compliance

Quality Assurance

Data Management

Clinical Research

Contract Management

Ethics Committee

Site Operations

Relevant Roles

Clinical Research Director

Principal Investigator

Research Coordinator

Legal Counsel

Regulatory Affairs Manager

Medical Director

Clinical Operations Manager

Research Ethics Committee Member

Data Protection Officer

Quality Assurance Manager

Clinical Trial Administrator

Site Manager

Compliance Officer

Contract Manager

Medical Science Liaison

Industries
Republic Act No. 11032 (Ease of Doing Business Act): Governs the general framework for business transactions and administrative procedures in the Philippines, including the processing of permits and licenses for clinical trials
FDA Administrative Order No. 2020-0010: Provides the updated guidelines for the conduct of clinical trials for investigational medicinal products in the Philippines, including requirements for ethics committee approval
Republic Act No. 10606 (National Health Insurance Act): Relevant for understanding healthcare coverage and liability aspects in clinical trials
Republic Act No. 10173 (Data Privacy Act of 2012): Governs the collection, handling, and protection of personal and sensitive information, including medical data of trial participants
Republic Act No. 8293 (Intellectual Property Code): Covers intellectual property rights aspects of clinical research, including protection of study results and innovations
Republic Act No. 3720 (Food, Drug and Cosmetic Act): Provides basic framework for regulation of drugs and medical devices, including those used in clinical trials
Philippine Civil Code: Governs general contract law principles applicable to the agreement, including formation, validity, and enforcement
DOH Administrative Order No. 2014-0034: Guidelines for Philippine Good Clinical Practice (GCP) compliance in clinical trials
Republic Act No. 9502 (Universally Accessible Cheaper and Quality Medicines Act): Relevant for understanding pharmaceutical regulations and pricing implications in clinical studies
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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