Investigator Agreement Template for Philippines

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Key Requirements PROMPT example:

Investigator Agreement

"I need an Investigator Agreement for a Phase III clinical trial in Manila, Philippines, to be conducted from March 2025 to December 2025, involving multiple sites and requiring specific provisions for handling biological samples and genetic data."

Document background
The Investigator Agreement serves as a critical document in the Philippine healthcare research landscape, establishing the legal and operational framework for clinical trials and medical research. This agreement is essential when engaging medical professionals to conduct clinical studies, typically used by pharmaceutical companies, research organizations, or healthcare institutions. The document must comply with Philippine FDA Administrative Order No. 2020-0010 for clinical trials, the Data Privacy Act of 2012, and other relevant healthcare regulations. The Investigator Agreement includes comprehensive details about study protocols, patient safety measures, data collection requirements, confidentiality obligations, and compensation terms. It's particularly important for ensuring regulatory compliance, protecting participant rights, and maintaining research integrity within the Philippine jurisdiction.
Suggested Sections

1. Parties: Identification of the research sponsor/institution and the investigator, including their legal capacities and addresses

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

3. Definitions: Definitions of key terms used throughout the agreement, including technical and legal terminology

4. Scope of Services: Detailed description of the investigator's roles, responsibilities, and services to be provided

5. Compliance with Laws and Regulations: Obligations to comply with Philippine laws, FDA regulations, and ethical guidelines

6. Study Protocol: Requirements for adherence to the study protocol and procedures for protocol amendments

7. Informed Consent: Procedures for obtaining and documenting informed consent from study participants

8. Data Collection and Reporting: Requirements for data collection, documentation, and reporting of study results

9. Confidentiality: Obligations regarding confidential information, including study data and trade secrets

10. Intellectual Property: Rights and obligations regarding inventions, discoveries, and other intellectual property

11. Compensation: Payment terms, schedule, and conditions for the investigator's services

12. Term and Termination: Duration of the agreement and circumstances for termination

13. Insurance and Indemnification: Insurance requirements and mutual indemnification provisions

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

Optional Sections

1. Publication Rights: Terms governing the publication of study results, applicable when publication rights are granted to the investigator

2. Equipment and Supplies: Provisions regarding study equipment and supplies, needed when sponsor provides equipment

3. Sub-investigators: Terms governing the appointment and oversight of sub-investigators, required when sub-investigators are permitted

4. Study Budget: Detailed budget provisions, necessary when complex payment structures are involved

5. Medical Records Access: Specific provisions for medical records access and maintenance, needed for studies involving patient records

6. Quality Assurance: Additional quality control measures, required for complex studies or when specifically requested

7. Safety Reporting: Detailed adverse event reporting procedures, necessary for high-risk studies

8. Study Drug/Device Handling: Procedures for handling study drugs or devices, required for clinical trials involving investigational products

Suggested Schedules

1. Schedule 1 - Study Protocol: Detailed protocol document outlining the research methodology and procedures

2. Schedule 2 - Payment Schedule: Detailed breakdown of payment terms, amounts, and timing

3. Schedule 3 - Timeline: Project timeline including key milestones and deadlines

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

5. Schedule 5 - Insurance Certificates: Copies of required insurance certificates and coverage details

6. Appendix A - Confidentiality Agreement: Detailed confidentiality terms and requirements

7. Appendix B - Data Protection Protocol: Specific procedures for handling and protecting study data

8. Appendix C - CV and Credentials: Investigator's curriculum vitae and relevant certifications

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

Relevant legal definitions
Clauses
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Academic Research

Healthcare Technology

Public Health

Relevant Teams

Legal

Clinical Operations

Research and Development

Regulatory Affairs

Medical Affairs

Clinical Development

Compliance

Research Ethics Committee

Contracts Administration

Clinical Quality Assurance

Relevant Roles

Principal Investigator

Clinical Research Director

Medical Director

Research Coordinator

Legal Counsel

Regulatory Affairs Manager

Clinical Operations Manager

Chief Medical Officer

Research Compliance Officer

Clinical Trial Manager

Healthcare Attorney

Medical Science Liaison

Research Ethics Committee Member

Clinical Development 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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