Investigator Agreement Template for Austria

The Investigator Agreement serves as a critical document in clinical research, establishing the legal and operational framework for conducting clinical trials in Austria. This agreement is required whenever a sponsor engages a Principal Investigator to conduct a clinical trial, whether in a hospital, academic, or private research setting. It must comply with Austrian legislation, particularly the Arzneimittelgesetz (AMG), EU Clinical Trials Regulation, and GDPR requirements. The agreement covers essential aspects such as protocol adherence, subject recruitment, data protection, safety reporting, and financial arrangements. It's designed to protect all parties' interests while ensuring compliance with regulatory requirements and ethical standards in clinical research. The document is particularly important as it defines the relationship between the sponsor and investigator while establishing clear lines of responsibility and accountability in trial conduct.

1. Parties: Identification of the contracting parties - typically the Sponsor/CRO and the Investigator, and possibly the Institution

2. Background: Context of the agreement, including brief description of the clinical trial and purpose

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

4. Scope of Services: Detailed description of the investigator's responsibilities and services to be provided

5. Compliance with Laws and Regulations: Obligations to comply with ICH-GCP, applicable laws, and regulatory requirements

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

7. Study Team and Delegation: Requirements regarding study team composition and delegation of responsibilities

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

9. Data Collection and Reporting: Requirements for data collection, CRF completion, and safety reporting

10. Confidentiality: Obligations regarding confidential information and trade secrets

11. Data Protection: GDPR compliance and data protection requirements

12. Intellectual Property: Rights and obligations regarding study-related IP and discoveries

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

14. Compensation and Payment Terms: Financial terms, payment schedule, and conditions

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

16. Insurance and Indemnification: Insurance requirements and indemnification provisions

17. Governing Law and Jurisdiction: Specification of Austrian law as governing law and jurisdiction for disputes

18. General Provisions: Standard legal provisions including notices, amendments, and assignment