Investigator Agreement Template for Switzerland

The Investigator Agreement is a crucial document in clinical research that establishes the legal and operational framework for conducting clinical trials in Switzerland. This agreement is required whenever a sponsor or CRO engages a Principal Investigator to conduct a clinical trial, whether in a hospital, academic, or private research setting. The document must comply with Swiss regulations, particularly the Human Research Act (HRA), Clinical Trials Ordinance (ClinO), and Federal Act on Data Protection (FADP). It outlines the investigator's responsibilities, including protocol adherence, patient safety measures, data collection and reporting requirements, confidentiality obligations, and intellectual property provisions. The agreement also addresses specific Swiss regulatory requirements, ethics committee approvals, and Swissmedic oversight where applicable. This document is essential for ensuring clear accountability and compliance with Swiss legal and regulatory frameworks in clinical research.

1. Parties: Identification of the contracting parties - typically the sponsor/institution and the investigator

2. Background: Context of the clinical trial, study identification, and purpose of the agreement

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

4. Scope of Services: Detailed description of the investigator's responsibilities and scope of work

5. Compliance with Laws and Regulations: Obligations to comply with Swiss laws, ICH GCP, and other applicable regulations

6. Study Protocol Adherence: Requirements for following the approved protocol and making any amendments

7. Data Collection and Reporting: Obligations regarding data collection, CRF completion, and reporting requirements

8. Confidentiality: Provisions for maintaining confidentiality of study information and results

9. Data Protection: Specific provisions for handling personal data in compliance with Swiss data protection laws

10. Intellectual Property: Rights and obligations regarding study-related intellectual property

11. Publication Rights: Terms governing the publication of study results

12. Compensation: Payment terms and conditions for the investigator's services

13. Term and Termination: Duration of the agreement and conditions for termination

14. Insurance and Liability: Insurance requirements and allocation of liabilities

15. General Provisions: Standard contractual provisions including governing law, jurisdiction, and entire agreement