Clinical Research Agreement Template for Germany

The Clinical Research Agreement serves as the primary contractual framework for conducting clinical trials in Germany, establishing the legal relationship between sponsors, research institutions, and investigators. This document is essential when initiating any clinical research project in Germany and must comply with the German Medicines Act (AMG), EU Clinical Trials Regulation, and German data protection laws. It outlines crucial elements including study protocol implementation, participant protection, data handling, financial arrangements, and regulatory compliance. The agreement is specifically adapted to German legal requirements while maintaining alignment with EU-wide clinical research standards, making it suitable for both domestic and international clinical trials conducted in German territory.

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

2. Background: Context of the clinical trial, purpose of the agreement, and basic information about the study

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

4. Scope of Trial: Detailed description of the clinical trial, including objectives, protocol compliance requirements, and timeline

5. Responsibilities of Institution: Obligations of the research institution, including compliance with protocol, regulations, and reporting requirements

6. Responsibilities of Sponsor: Sponsor's obligations including provision of study drug, monitoring, and regulatory compliance

7. Principal Investigator Obligations: Specific duties and commitments of the principal investigator

8. Budget and Payment Terms: Financial terms, payment schedule, and cost coverage

9. Confidentiality: Confidentiality obligations and protection of proprietary information

10. Data Protection: GDPR compliance, data handling, and protection measures

11. Intellectual Property: Ownership and rights to study results, inventions, and publications

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

13. Subject Injury and Indemnification: Liability allocation and compensation for trial-related injuries

14. Insurance: Insurance requirements and coverage specifications

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

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

17. General Provisions: Standard contractual provisions including notices, amendments, and assignment