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.
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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
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
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
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
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