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The Investigator Agreement serves as the primary contractual document establishing the relationship between a clinical trial sponsor and the medical professional responsible for conducting the research. This document is essential for any clinical trial conducted in Germany, ensuring compliance with the German Medicines Act (AMG), EU Clinical Trials Regulation, and local regulatory requirements. It details the investigator's responsibilities, including protocol adherence, subject recruitment, safety monitoring, and data collection, while addressing specific German legal requirements for medical research. The agreement includes provisions for data protection under GDPR, insurance requirements specific to German law, and mandatory reporting obligations. It is typically used when initiating a new clinical trial and must be in place before any study-related activities can commence.

1. Parties: Identifies the contract parties: typically the sponsor/CRO and the investigator, potentially including the institution

2. Background: Outlines the context of the clinical trial, study objectives, and parties' qualifications

3. Definitions: Defines key terms used throughout the agreement, including study-specific terminology

4. Scope of Services: Details the investigator's responsibilities and specific services to be provided in conducting the clinical trial

5. Compliance with Laws and Regulations: Obligations to comply with German and EU regulations, GCP, and protocol requirements

6. Protocol Adherence: Requirements for following the study protocol and managing protocol amendments

7. Subject Recruitment and Informed Consent: Procedures for participant recruitment and obtaining informed consent

8. Data Collection and Reporting: Requirements for data collection, CRF completion, and adverse event reporting

9. Confidentiality: Provisions for protecting confidential information and trial data

10. Data Protection: GDPR compliance requirements and data processing obligations

11. Compensation and Payment Terms: Payment schedule, amounts, and conditions for payment

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

13. Insurance and Liability: Insurance requirements and allocation of liability as per German law

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

15. Governing Law and Jurisdiction: Specification of German law application and jurisdiction