Clinical Study Agreement Template for Denmark

The Clinical Study Agreement serves as the primary contractual framework for conducting clinical trials in Denmark, establishing the legal relationship between sponsors, research institutions, and investigators. This document is essential when initiating any clinical research study in Denmark and must comply with the Danish Medicines Act, EU Clinical Trials Regulation, and local regulatory requirements. It is used to define roles, responsibilities, and obligations of all parties involved in the clinical trial, including provisions for patient safety, data protection under GDPR, financial arrangements, and intellectual property rights. The agreement must address specific Danish legal requirements while also maintaining alignment with EU-wide clinical trial regulations and Good Clinical Practice guidelines. This document is particularly crucial as it forms the basis for regulatory compliance and helps ensure the proper conduct of clinical research within the Danish healthcare system.

1. Parties: Identification of the contracting parties including Sponsor, Institution, and Principal Investigator

2. Background: Context of the clinical trial, study objectives, and basis for the agreement

3. Definitions: Key terms used throughout the agreement including Study, Protocol, Study Drug, and other relevant terminology

4. Conduct of the Study: Core obligations regarding study execution, compliance with Protocol, and regulatory requirements

5. Regulatory Compliance: Obligations regarding compliance with Danish laws, EU regulations, GCP, and ethical guidelines

6. Principal Investigator and Study Team: Roles, responsibilities, and qualifications requirements

7. Patient Recruitment and Informed Consent: Requirements and procedures for patient enrollment and consent processes

8. Study Drug and Materials: Management, storage, and accountability of study medication and materials

9. Data Management and Protection: Handling of study data, compliance with GDPR and Danish data protection laws

10. Safety Reporting: Adverse event reporting obligations and safety monitoring procedures

11. Financial Arrangements: Payment terms, budget, and financial aspects of the study

12. Confidentiality: Protection of confidential information and trade secrets

13. Intellectual Property: Ownership and rights to study results, data, and inventions

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

15. Insurance and Indemnification: Liability coverage, insurance requirements, and indemnification provisions

16. Term and Termination: Duration of agreement, termination rights and procedures

17. Governing Law and Jurisdiction: Application of Danish law and jurisdiction provisions

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