Investigator Agreement Template for Ireland

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Key Requirements PROMPT example:

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."

Document background
The Investigator Agreement is a critical document used in the Irish clinical research landscape when engaging medical professionals or researchers to conduct clinical trials or research studies. It serves as the primary contract between research sponsors (such as pharmaceutical companies or research institutions) and investigators who will conduct the research. This document is essential for compliance with Irish and EU regulations, including the Clinical Trials Regulation (EU) No 536/2014 and its Irish implementation through S.I. No. 99/2022. The agreement covers comprehensive aspects of the research relationship including protocol compliance, data protection under GDPR, safety reporting, financial terms, and intellectual property rights. It's particularly important in Ireland's growing life sciences sector and must align with requirements from the Health Products Regulatory Authority (HPRA) and relevant ethics committees.
Suggested Sections

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

Optional Sections

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

Suggested Schedules

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

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
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Academic Research

Life Sciences

Healthcare Technology

Relevant Teams

Legal

Clinical Operations

Research & Development

Regulatory Affairs

Medical Affairs

Clinical Development

Compliance

Quality Assurance

Data Management

Safety Monitoring

Contract Management

Ethics Committee

Relevant Roles

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

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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