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Clinical Study Agreement

Clinical Study Agreement Template for Belgium

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Key Requirements PROMPT example:

Clinical Study Agreement

"I need a Clinical Study Agreement under Belgian law for a Phase II oncology trial starting March 2025, involving multiple research sites and including specific provisions for biological sample collection and biomarker analysis."

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Document background
The Clinical Study Agreement is essential for any clinical trial conducted in Belgium, serving as the primary contractual framework between sponsors, research institutions, and investigators. This agreement is required when conducting clinical research involving human subjects and must comply with Belgian law, including the Law of 7 May 2004 on Experiments on Human Persons, as well as EU Clinical Trials Regulation 536/2014. The document covers crucial aspects such as trial conduct, data protection under GDPR, financial arrangements, liability provisions, and intellectual property rights. It's particularly important as Belgium is a key hub for clinical research in Europe, with specific regulatory requirements that must be carefully addressed in the agreement structure. The document should be used whenever a clinical trial is initiated in Belgium, whether by pharmaceutical companies, biotechnology firms, or academic institutions.
Suggested Sections

1. Parties: Identification of all contracting parties including the Sponsor, Institution, Principal Investigator, and any relevant third parties

2. Background: Context of the clinical study, including the investigational product and general purpose of the trial

3. Definitions: Detailed definitions of terms used throughout the agreement

4. Study Conduct: Requirements and standards for conducting the study, including compliance with protocol and applicable laws

5. Responsibilities of the Institution: Detailed obligations of the healthcare institution regarding study execution

6. Responsibilities of the Principal Investigator: Specific duties and commitments of the Principal Investigator

7. Responsibilities of the Sponsor: Obligations of the study sponsor including provision of materials and oversight

8. Budget and Payment Terms: Financial arrangements, payment schedule, and cost coverage

9. Confidentiality: Provisions for protecting confidential information shared during the study

10. Data Protection: GDPR compliance measures and data handling requirements

11. Intellectual Property: Rights and ownership of study results, inventions, and publications

12. Publication Rights: Terms for publishing study results and academic publications

13. Subject Injury and Indemnification: Liability and compensation provisions for trial-related injuries

14. Term and Termination: Duration of agreement and conditions for termination

15. Governing Law and Jurisdiction: Specification of Belgian law application and dispute resolution procedures

Optional Sections

1. Study Drug Supply: Specific terms for drug handling and accountability - include when the study involves investigational medicinal products

2. Equipment Provision: Terms for supplied equipment management - include when sponsor provides specific equipment for the study

3. Sub-Investigator Obligations: Additional terms for other investigators - include when multiple investigators are involved

4. Monitoring and Auditing: Specific provisions for study monitoring - include for complex studies requiring enhanced oversight

5. Multi-Center Study Provisions: Additional terms for multi-center coordination - include when study involves multiple sites

6. Biological Sample Management: Terms for handling biological specimens - include when study involves sample collection

7. Archive Requirements: Specific archiving obligations - include when special record retention requirements apply

8. Translation Requirements: Provisions for document translation - include when study documents need translation to local languages

Suggested Schedules

1. Schedule 1 - Protocol: The approved study protocol including all amendments

2. Schedule 2 - Budget and Payment Schedule: Detailed financial breakdown and payment terms

3. Schedule 3 - Division of Responsibilities: Matrix of responsibilities between sponsor, institution, and investigator

4. Schedule 4 - Data Processing Agreement: Detailed GDPR-compliant data processing terms

5. Schedule 5 - Insurance Certificates: Proof of required insurance coverage

6. Schedule 6 - Form of Patient Informed Consent: Approved informed consent forms and patient information

7. Schedule 7 - Equipment List: Detailed list of provided equipment and terms of use

8. Schedule 8 - Study Timeline: Expected milestones and study completion timeline

9. Appendix A - EC/Regulatory Approvals: Copies of ethics committee and regulatory authority approvals

10. Appendix B - CV and Licenses: Principal Investigator's credentials and relevant certifications

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













































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Relevant Industries

Pharmaceutical

Healthcare

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Laboratory Services

Academic Medical Research

Contract Research Services

Life Sciences

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research & Development

Medical Affairs

Clinical Research

Compliance

Data Protection

Finance

Business Development

Contract Management

Quality Assurance

Ethics Office

Site Management

Clinical Documentation

Relevant Roles

Clinical Research Director

Legal Counsel

Principal Investigator

Clinical Trial Manager

Research Coordinator

Medical Director

Regulatory Affairs Manager

Contract Manager

Ethics Committee Chairman

Site Director

Clinical Operations Manager

Data Protection Officer

Chief Medical Officer

Research Compliance Officer

Business Development Manager

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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