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This Data Transfer Agreement Clinical Trial template is essential for organizations conducting clinical trials in Denmark that involve the transfer of patient data, trial results, and related clinical information between parties. The document ensures compliance with Danish law, EU GDPR requirements, and specific clinical trial regulations while establishing clear protocols for data handling, security measures, and party responsibilities. It should be used whenever clinical trial data needs to be transferred between sponsors, research organizations, healthcare institutions, or other involved parties. The agreement covers crucial aspects such as data protection measures, breach notification procedures, regulatory reporting requirements, and specific Danish healthcare data handling standards. It is particularly important given Denmark's strict regulatory framework for clinical trials and personal data protection.

1. Parties: Identification of the data exporter and data importer, including their roles (e.g., controller, processor) and full contact details

2. Background: Context of the clinical trial, purpose of the data transfer agreement, and relationship to the main clinical trial agreement

3. Definitions: Key terms including Clinical Trial-specific terminology, data protection terms, and any jurisdiction-specific definitions

4. Subject Matter and Duration: Details of the specific data transfers, duration of processing, and link to the clinical trial protocol

5. Nature and Purpose of Processing: Detailed description of how the data will be used, processed, and analyzed in the context of the clinical trial

6. Types of Personal Data: Specific categories of personal data being transferred, including special categories of data (health data)

7. Data Subject Rights: Procedures for handling data subject requests and ensuring compliance with GDPR rights

8. Security Measures: Technical and organizational measures required for data protection and compliance with GCP requirements

9. Sub-processing: Conditions and requirements for engaging sub-processors in the data processing activities

10. Data Breach Notification: Procedures for handling and reporting data breaches, including timing and responsibilities

11. Audit Rights: Provisions for conducting audits and inspections of data processing activities

12. Transfer Mechanisms: Legal basis for data transfers and applicable transfer mechanisms

13. Liability and Indemnification: Allocation of responsibilities and liabilities between parties

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

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