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Clinical Research Agreement Template for Switzerland

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Key Requirements PROMPT example:

Clinical Research Agreement

"I need a Clinical Research Agreement under Swiss law for a Phase II oncology trial sponsored by my pharmaceutical company, to be conducted at three hospitals in Geneva starting March 2025, with specific provisions for biological sample handling and data protection compliance."

Document background
The Clinical Research Agreement (CRA) is a fundamental document used when conducting clinical research studies in Switzerland. It is required whenever a research institution, pharmaceutical company, or sponsor wishes to conduct clinical trials or research involving human subjects under Swiss jurisdiction. The agreement must comply with the Swiss Human Research Act, Clinical Trials Ordinance, and related regulations, while also adhering to international standards like ICH-GCP. This document is essential for defining the legal relationship between parties, outlining financial arrangements, establishing data protection protocols, and ensuring proper risk allocation. It includes specific provisions required by Swiss law regarding subject protection, liability insurance, and regulatory compliance, making it distinct from clinical research agreements in other jurisdictions. The CRA serves as the primary contractual framework that enables the practical implementation of clinical research while protecting the interests of all parties involved, including research subjects.
Suggested Sections

1. Parties: Identification of the contracting parties including the research institution, sponsor, and principal investigator

2. Background: Context of the research, brief description of the study, and the parties' expertise and interests

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

4. Scope of Services: Detailed description of the clinical research to be conducted and each party's responsibilities

5. Regulatory Compliance: Obligations regarding compliance with Swiss regulations, particularly the Human Research Act and ICH-GCP Guidelines

6. Study Protocol: Reference to and incorporation of the study protocol, including compliance requirements

7. Timeline and Study Duration: Project timeline, key milestones, and duration of the study

8. Financial Provisions: Payment terms, schedule, and financial responsibilities

9. Confidentiality: Protection of confidential information and trade secrets

10. Data Protection and Privacy: Compliance with Swiss data protection laws and handling of personal data

11. Intellectual Property Rights: Ownership and rights to study results, inventions, and other IP

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

13. Insurance and Liability: Insurance requirements and allocation of liability

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

15. Governing Law and Jurisdiction: Swiss law as governing law and jurisdiction provisions

Optional Sections

1. Multi-Center Study Provisions: Additional terms for multi-center studies, used when the research is conducted at multiple sites

2. Third Party Funding: Provisions relating to external funding sources, used when study is funded by external parties

3. Equipment and Materials: Terms for supplied equipment and materials, used when sponsor provides specific equipment

4. Biological Materials Handling: Specific provisions for handling biological materials, used when study involves human tissue or samples

5. Subject Injury Compensation: Specific compensation terms for research subject injuries, used when required by risk assessment

6. Independent Contractor Status: Clarification of relationship between parties, used when needed to prevent misclassification

7. Force Majeure: Provisions for unforeseen circumstances, used in longer-term studies

8. Anti-Corruption Compliance: Specific anti-corruption provisions, used when required by sponsor or regulatory requirements

Suggested Schedules

1. Schedule 1 - Study Protocol: Detailed protocol describing the clinical research methodology and procedures

2. Schedule 2 - Budget and Payment Schedule: Detailed financial terms, payment amounts, and timing

3. Schedule 3 - Timeline and Milestones: Detailed project timeline with specific milestones and deadlines

4. Schedule 4 - Personnel and Key Contacts: List of key personnel and their roles, including principal investigator

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

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

7. Appendix B - Form of Informed Consent: Approved form of patient informed consent and information sheets

8. Appendix C - Data Processing Agreement: Detailed terms for processing personal data in compliance with Swiss law

9. Appendix D - Quality Assurance Requirements: Specific quality control and assurance procedures

Authors

Alex Denne

Head of Growth (Open Source Law) @ ¶¶Òõ¶ÌÊÓÆµ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Relevant legal definitions








































Clauses







































Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Life Sciences

Healthcare Technology

Academic Medical Research

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research Administration

Clinical Research

Compliance

Medical Affairs

Data Protection

Finance

Contract Management

Quality Assurance

Relevant Roles

Clinical Research Director

Principal Investigator

Research Coordinator

Legal Counsel

Regulatory Affairs Manager

Clinical Operations Manager

Chief Medical Officer

Research Ethics Officer

Data Protection Officer

Contract Manager

Clinical Trial Manager

Medical Director

Research Administrator

Compliance Officer

Finance Manager

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

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