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Clinical Research Agreement

Clinical Research Agreement Template for Philippines

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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 hospital sites in Manila, starting March 2025, with specific provisions for biological sample handling and local community benefits."

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Document background
The Clinical Research Agreement is essential for organizations conducting clinical trials or research studies in the Philippines. It serves as the primary contractual framework between research institutions, pharmaceutical companies or sponsors, and investigators, ensuring compliance with Philippine FDA regulations, particularly FDA Circular No. 2012-007 and the National Ethical Guidelines for Health Research. This agreement is required when conducting any clinical research involving human subjects in the Philippines, whether for drug development, medical devices, or other healthcare interventions. It addresses critical aspects such as protocol implementation, participant safety, data protection under the Philippine Data Privacy Act, financial arrangements, and intellectual property rights. The document must align with both local Philippine regulations and international Good Clinical Practice (GCP) standards.
Suggested Sections

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

2. Background: Context of the research, purpose of the agreement, and brief description of the study

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

4. Scope of Services: Detailed description of the clinical research to be conducted, including study objectives and design

5. Responsibilities of Parties: Specific obligations of each party, including the institution, sponsor, and principal investigator

6. Study Timeline: Project schedule, key milestones, and duration of the study

7. Payment Terms: Financial arrangements, payment schedule, and budget details

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

9. Data Protection and Privacy: Compliance with Philippine Data Privacy Act and handling of personal/sensitive information

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

11. Regulatory Compliance: Compliance with FDA Philippines regulations and other applicable laws

12. Subject Safety and Ethics: Human subject protection, informed consent, and ethical guidelines compliance

13. Insurance and Indemnification: Coverage requirements and liability provisions

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 research sites

2. Equipment and Materials: Terms regarding provision and use of specific equipment or materials, if supplied by sponsor

3. Biological Materials Handling: Specific provisions for handling biological samples and materials

4. Third Party Contractors: Terms governing the involvement of external contractors or service providers

5. Publication Rights: Detailed publication procedures and restrictions, if publication is permitted

6. Post-Study Obligations: Continuing obligations after study completion, including access to study drug

7. Technology Transfer: Terms for any technology or knowledge transfer components

8. Local Community Benefits: Provisions for benefits to local community or healthcare system

Suggested Schedules

1. Protocol: Detailed research protocol including methodology and procedures

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

3. Study Timeline: Detailed project schedule with milestones and deadlines

4. Personnel and Key Contacts: List of key team members and their roles

5. Required Reports and Documentation: Templates and specifications for required reporting

6. Insurance Certificates: Copies of required insurance policies

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

8. Quality Assurance Requirements: Specific quality control and monitoring procedures

9. Form of Informed Consent: Template and requirements for participant informed consent

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

Authors

Alex Denne

Head of Growth (Open Source Law) @ Ƶ | 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 Devices

Clinical Research

Healthcare Technology

Academic Research

Public Health

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research & Development

Medical Affairs

Data Management

Quality Assurance

Compliance

Contract Management

Ethics Review

Clinical Research

Relevant Roles

Clinical Research Director

Principal Investigator

Research Coordinator

Legal Counsel

Regulatory Affairs Manager

Clinical Operations Manager

Medical Director

Ethics Committee Chairman

Data Protection Officer

Clinical Trial Manager

Research Compliance Officer

Contract Manager

Chief Medical Officer

Research Administrator

Site Director

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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