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Clinical Research Contract Template for Switzerland

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Key Requirements PROMPT example:

Clinical Research Contracts

"I need a Clinical Research Contract under Swiss law for a multi-center phase III trial of a new diabetes medication, where our pharmaceutical company will collaborate with three university hospitals starting March 2025, with specific provisions for biological sample handling and data sharing between sites."

Document background
Clinical Research Contracts under Swiss law are essential documents used when establishing formal relationships between parties involved in clinical studies within Switzerland. These contracts are specifically designed to comply with Swiss regulations, including the Human Research Act (HRA), Clinical Trials Ordinance (ClinO), and Federal Act on Data Protection (FADP). They are typically employed when a sponsor wishes to conduct clinical research at a Swiss institution, requiring detailed provisions for protocol implementation, regulatory compliance, data handling, and risk allocation. The contract serves as the primary legal framework governing the research relationship, ensuring proper protection of human subjects, clear delineation of responsibilities, and appropriate management of research outcomes while maintaining alignment with Swiss regulatory requirements and international good clinical practice standards.
Suggested Sections

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

2. Background: Context of the clinical research, purpose of the agreement, and brief description of the study

3. Definitions: Detailed definitions of technical terms, regulatory references, and key concepts 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 laws, particularly HRA, ICH-GCP, and ethics committee approvals

6. Study Protocol: Requirements for adherence to the approved protocol and procedures for amendments

7. Personnel and Resources: Requirements for qualified personnel, facilities, and resources needed for the study

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

9. Data Protection and Privacy: Compliance with FADP and handling of personal/patient data

10. Confidentiality: Protection of confidential information and trade secrets

11. Intellectual Property Rights: Ownership and usage rights of study results, data, and innovations

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

13. Liability and Indemnification: Allocation of risks, insurance requirements, and indemnification obligations

14. Term and Termination: Duration of agreement, termination rights, and post-termination obligations

15. General Provisions: Standard clauses including governing law, jurisdiction, and dispute resolution

Optional Sections

1. Multi-Center Study Provisions: Additional terms for studies conducted across multiple research sites

2. Biological Materials Handling: Specific provisions for collection, storage, and transfer of biological samples

3. Device/Equipment Provisions: Terms for use and maintenance of specialized equipment or medical devices

4. Sub-contractor Management: Requirements for engaging and managing sub-contractors

5. Pharmacovigilance: Specific provisions for adverse event reporting and safety monitoring

6. Technology Transfer: Terms for any technology or know-how transfer between parties

7. Data Sharing Agreements: Additional terms for sharing data with third parties or databases

Suggested Schedules

1. Study Protocol: Detailed protocol document including study design and procedures

2. Budget and Payment Schedule: Detailed breakdown of costs and payment milestones

3. Personnel and Responsibilities: List of key personnel and their roles/responsibilities

4. Timeline and Milestones: Detailed project schedule and key deliverables

5. Quality Assurance Requirements: Specific quality control and assurance procedures

6. Data Management Plan: Detailed procedures for data collection, storage, and handling

7. Monitoring and Reporting Requirements: Schedule and format of required reports and monitoring activities

8. Insurance Certificates: Copies of required insurance policies and certificates

9. Form of Ethics Committee Approval: Template or copy of ethics committee approval

10. Safety Reporting Procedures: Detailed procedures for adverse event reporting

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 Research

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Medical Affairs

Research and Development

Compliance

Quality Assurance

Data Management

Contract Management

Business Development

Ethics Committee

Relevant Roles

Clinical Research Director

Legal Counsel

Principal Investigator

Research Coordinator

Clinical Operations Manager

Regulatory Affairs Manager

Medical Director

Contract Manager

Chief Medical Officer

Clinical Trial Manager

Data Protection Officer

Quality Assurance Manager

Research Ethics Officer

Clinical Research Associate

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

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