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Investigator Agreement
"I need an Investigator Agreement for a Phase II pharmaceutical trial starting March 2025, governed by Irish law, between our Dublin-based research institution and multiple investigators across three hospital sites, with specific provisions for handling biological samples and data sharing."
1. Parties: Identification of the contracting parties (typically the research institution/sponsor and the investigator)
2. Background: Context of the agreement, including the research project overview and purpose
3. Definitions: Detailed definitions of key terms used throughout the agreement
4. Appointment and Scope: Terms of the investigator's appointment and scope of responsibilities
5. Investigator Obligations: Detailed responsibilities including protocol compliance, reporting, and supervision
6. Sponsor Obligations: Responsibilities of the sponsoring institution including support and resources
7. Compliance with Laws and Regulations: Requirements for regulatory compliance, including Clinical Trials Regulation
8. Data Protection and Confidentiality: GDPR compliance and confidentiality obligations
9. Intellectual Property Rights: Ownership and rights regarding research outputs and discoveries
10. Publication Rights: Terms governing the publication of research results
11. compensation: Payment terms and financial arrangements
12. Term and Termination: Duration of agreement and termination provisions
13. Insurance and Liability: Insurance requirements and allocation of liability
14. General Provisions: Standard legal provisions including governing law and dispute resolution
1. Equipment and Materials: Used when specific research equipment or materials are provided
2. Multi-Site Provisions: Required for studies conducted across multiple locations
3. Sub-Investigator Requirements: Needed when the study involves delegation to sub-investigators
4. Specialized Procedures: For studies involving unique or high-risk procedures
5. Safety Reporting: Detailed safety reporting requirements for high-risk studies
6. Technology Transfer: When specific technology or know-how transfer is involved
7. Subject Recruitment: Specific provisions for participant recruitment if applicable
8. Biological Samples: Requirements for handling biological materials if relevant
1. Research Protocol: Detailed protocol of the research study
2. Budget and Payment Schedule: Detailed financial terms and payment milestones
3. Required Documentation: List of required regulatory and ethical approvals
4. Data Management Plan: Detailed procedures for data collection and management
5. Reporting Requirements: Templates and schedules for required reports
6. Team Members and Responsibilities: List of authorized personnel and their roles
7. Insurance Certificates: Copies of required insurance documentation
8. Form of Progress Reports: Templates for progress reporting
9. Safety Reporting Procedures: Detailed procedures for adverse event reporting
Authors
Applicable Laws
Approved Protocol
Authorised Personnel
Background IP
Clinical Trial
Confidential Information
CRF (Case Report Form)
Data Protection Laws
Effective Date
Ethics Committee
Foreground IP
GCP (Good Clinical Practice)
GDPR
HPRA
Institution
Investigation Site
Investigational Product
Investigator
Medical Records
Patient
Personal Data
Principal Investigator
Protocol
Regulatory Authorities
Research
Research Data
Research Staff
Research Subject
Safety Report
Sample
Serious Adverse Event
Sponsor
Study
Study Completion Date
Study Documentation
Study Materials
Study Results
Study Start Date
Sub-Investigator
Subject
Term
Territory
Trial
Trial Subject
Compliance
Confidentiality
Data Protection
Definitions
Dispute Resolution
Ethics Committee Approval
Force Majeure
Governing Law
Health and Safety
Indemnification
Insurance
Intellectual Property
Investigation Procedures
Liability
Notice
Payment
Publication Rights
Record Keeping
Regulatory Compliance
Research Protocol
Safety Reporting
Severability
Study Materials
Subject Recruitment
Term and Termination
Warranties
Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Clinical Research
Academic Research
Life Sciences
Healthcare Technology
Legal
Clinical Operations
Research & Development
Regulatory Affairs
Medical Affairs
Clinical Development
Compliance
Quality Assurance
Data Management
Safety Monitoring
Contract Management
Ethics Committee
Principal Investigator
Clinical Research Coordinator
Medical Director
Research Manager
Clinical Trial Manager
Chief Medical Officer
Research Physician
Clinical Operations Director
Regulatory Affairs Manager
Legal Counsel
Research Compliance Officer
Clinical Development Director
Study Site Manager
Medical Science Liaison
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