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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."
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
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
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
Agreement
Applicable Laws
Confidential Information
Clinical Trial
Case Report Form
Data
Effective Date
FDA
Good Clinical Practice
Institution
Investigational Product
Investigator
Intellectual Property Rights
Informed Consent Form
Monitor
Personal Data
Protocol
Research Subject
Research Staff
Regulatory Authority
Serious Adverse Event
Sponsor
Study
Study Documentation
Study Site
Sub-Investigator
Term
Trial Materials
Study Results
Study Completion
Subject Information
Philippines FDA
Ethics Committee
Research Ethics Board
Investigator's Brochure
Source Documents
Study Budget
Trial Master File
Safety Report
Quality Assurance
Research Timelines
Background IP
Foreground IP
Protected Health Information
Study Protocol Deviation
Study Close-out
Scope of Services
Compliance with Laws
Protocol Adherence
Regulatory Compliance
Subject Enrollment
Informed Consent
Data Collection
Record Keeping
Confidentiality
Data Protection
Intellectual Property
Publication Rights
Compensation
Payment Terms
Study Materials
Quality Assurance
Monitoring and Audits
Safety Reporting
Insurance
Indemnification
Term
Termination
Force Majeure
Assignment
Governing Law
Dispute Resolution
Amendments
Notices
Entire Agreement
Severability
Ethics Committee Approval
Staff Requirements
Research Standards
Site Management
Documentation Requirements
Reporting Obligations
Risk Management
Representations and Warranties
Conflict of Interest
Anti-corruption
Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Clinical Research
Academic Research
Healthcare Technology
Public Health
Legal
Clinical Operations
Research and Development
Regulatory Affairs
Medical Affairs
Clinical Development
Compliance
Research Ethics Committee
Contracts Administration
Clinical Quality Assurance
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
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