Investigator Agreement

Investigator Agreement Template for Denmark

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Document background

The Investigator Agreement serves as a crucial legal document in clinical research settings within Denmark, establishing the contractual relationship between research sponsors and clinical investigators. This agreement is essential when conducting clinical trials or medical research in Denmark, ensuring compliance with Danish legislation, EU regulations (including Clinical Trials Regulation 536/2014), and international GCP standards. The document details the investigator's obligations in conducting the study, handling patient data, maintaining confidentiality, and adhering to protocol requirements. It includes specific provisions required under Danish law regarding data protection, patient rights, and research ethics, while also addressing payment terms, publication rights, and liability considerations. The agreement is typically used when initiating new clinical studies and must align with approvals from Danish regulatory authorities and ethics committees.

Suggested Sections

1. Parties: Identification of the contracting parties - typically the Sponsor/CRO and the Investigator, including full legal names and addresses

2. Background: Context of the clinical trial, including study identification 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 Danish laws, EU regulations, GCP, and other applicable requirements

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

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

8. Data Collection and Reporting: Requirements for data collection, recording, and reporting, including adverse events

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

10. Data Protection: GDPR compliance and data protection requirements specific to Denmark

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

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

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

14. Insurance and Indemnification: Insurance requirements and indemnification provisions

15. Governing Law and Jurisdiction: Specification of Danish law as governing law and jurisdiction for disputes

16. General Provisions: Standard contractual provisions including amendments, assignments, and notices

Optional Sections

1. Institution Involvement: Required when the Investigator is affiliated with an institution that needs to be party to the agreement

2. Sub-Investigator Obligations: Needed when sub-investigators will be involved in the study

3. Equipment and Supplies: Include when specific equipment or supplies are provided for the study

4. Biological Samples: Required when the study involves collection and handling of biological samples

5. Intellectual Property Rights: Needed when there's potential for new IP development during the study

6. Study Drug Management: Include for studies involving investigational medicinal products

7. Quality Assurance: Detailed quality control procedures when beyond standard requirements

8. Translation Requirements: Include when study materials require translation

9. Conflict Resolution: Specific dispute resolution procedures beyond standard jurisdiction clause

Suggested Schedules

1. Schedule A - Protocol: Summary or reference to the approved clinical trial protocol

2. Schedule B - Budget and Payment Schedule: Detailed breakdown of payments, including visit fees, procedures, and payment timing

3. Schedule C - Timeline: Study timeline including key milestones and deadlines

4. Schedule D - Data Processing Agreement: GDPR-compliant data processing terms and requirements

5. Schedule E - Division of Responsibilities: Detailed matrix of responsibilities between parties

6. Appendix 1 - Form of Informed Consent: Approved informed consent template

7. Appendix 2 - CV and Licenses: Investigator's curriculum vitae and professional licenses

8. Appendix 3 - Insurance Certificates: Copies of required insurance documentation

9. Appendix 4 - Monitoring Requirements: Specific monitoring procedures and requirements

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