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Investigator Agreement

Investigator Agreement Template for Belgium

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Key Requirements PROMPT example:

Investigator Agreement

"I need an Investigator Agreement for a Phase III pharmaceutical trial starting in March 2025, compliant with Belgian law, that will involve multiple investigation sites and sub-investigators, with specific provisions for biological sample handling and storage."

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Document background
The Investigator Agreement is a crucial document used in clinical research settings in Belgium when engaging medical professionals to conduct clinical trials. It establishes the legal and operational framework between the sponsor organization and the investigator who will lead the clinical study. This agreement must comply with Belgian legislation, particularly the Law of 7 May 2004 on Experiments on Human Persons, as well as EU regulations including the Clinical Trials Regulation 536/2014 and GDPR. The document typically includes detailed provisions on study protocol compliance, subject safety, data protection, financial arrangements, and regulatory obligations. It's essential for ensuring clear accountability and compliance in clinical research, protecting all parties' interests while maintaining high ethical and scientific standards.
Suggested Sections

1. Parties: Identification of the contracting parties (typically the Sponsor and the Investigator, and possibly the Institution)

2. Background: Context of the agreement, including brief description of the clinical trial and its purpose

3. Definitions: Definitions of key terms used throughout the agreement

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

5. Compliance with Laws and Regulations: Obligations to comply with applicable laws, regulations, and guidelines

6. Study Protocol: Requirements for adherence to the study protocol and any modifications

7. Informed Consent: Requirements for obtaining and documenting informed consent from study subjects

8. Data Protection and Privacy: GDPR compliance and data protection obligations

9. Confidentiality: Confidentiality obligations regarding study information and results

10. Documentation and Record Keeping: Requirements for maintaining study records and documentation

11. Compensation and Payment Terms: Financial terms, payment schedule, and conditions

12. Publication Rights: Rights and procedures for publishing study results

13. Intellectual Property: Ownership and rights to inventions, data, and results

14. Insurance and Indemnification: Insurance requirements and indemnification provisions

15. Term and Termination: Duration of agreement and termination provisions

16. Dispute Resolution: Procedures for resolving disputes and applicable law

17. General Provisions: Standard legal provisions including notices, assignment, and entire agreement

Optional Sections

1. Equipment and Materials: Terms regarding sponsor-provided equipment and materials, used when sponsor provides specific equipment for the study

2. Sub-Investigators: Provisions regarding the appointment and responsibilities of sub-investigators, included when sub-investigators are expected to be involved

3. Site Requirements: Specific requirements for the study site, included when there are special facility requirements

4. Study Drug Storage: Specific provisions for handling and storing study medication, included for drug trials

5. Quality Assurance: Additional quality control measures, included for complex studies or at sponsor's request

6. Subject Injury: Specific provisions for handling research-related injuries, included when not covered in main indemnification

7. Biological Samples: Provisions for handling biological samples, included when study involves sample collection

8. Translation Requirements: Requirements for translation of study materials, included for multi-language studies

Suggested Schedules

1. Schedule 1 - Study Protocol: Detailed protocol for the clinical trial

2. Schedule 2 - Payment Schedule: Detailed breakdown of payments, timing, and conditions

3. Schedule 3 - Budget: Detailed study budget including per-patient costs and overhead

4. Schedule 4 - Timeline: Study timeline including key milestones and deadlines

5. Schedule 5 - Required Documentation: List of required regulatory and study documentation

6. Appendix A - Insurance Certificates: Copies of required insurance certificates

7. Appendix B - Form of Informed Consent: Template informed consent form

8. Appendix C - Data Protection Agreement: Detailed GDPR-compliant data protection terms

9. Appendix D - Quality Requirements: Detailed quality assurance and control requirements

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok成人版 | 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

Pharmaceuticals

Biotechnology

Medical Devices

Healthcare Services

Clinical Research

Academic Medical Research

Contract Research

Life Sciences

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Medical Affairs

Clinical Development

Research & Development

Quality Assurance

Compliance

Data Protection

Contract Management

Clinical Research

Relevant Roles

Clinical Research Director

Principal Investigator

Medical Director

Clinical Operations Manager

Legal Counsel

Regulatory Affairs Manager

Clinical Trial Manager

Research Physician

Medical Science Liaison

Clinical Research Coordinator

Ethics Committee Member

Quality Assurance Manager

Data Protection Officer

Contract Manager

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, 聽Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination, 聽Severance Pay, Governing Law, Entire Agreemen

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