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.
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Key Requirements PROMPT example:
Data Transfer Agreement Clinical Trial
I need a Data Transfer Agreement Clinical Trial under Danish law for a Phase III oncology trial starting March 2025, involving data transfers between our Copenhagen headquarters, three Danish hospitals, and our research facility in Germany, with specific provisions for handling sensitive patient data and biomarker information.
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
1. Emergency Procedures: Include when the clinical trial involves critical safety reporting requirements or emergency scenarios
2. Data Retention and Destruction: Include specific retention requirements beyond standard terms when required by the trial protocol
3. Cross-border Transfers: Include when data will be transferred outside the EU/EEA
4. Regulatory Authority Access: Include when specific provisions for regulatory authority access need to be detailed
5. Intellectual Property Rights: Include when there are specific IP considerations related to the processed data
6. Insurance Requirements: Include when specific insurance coverage for data processing activities is required
7. Language Requirements: Include when documents need to be maintained in multiple languages
8. Force Majeure: Include when specific circumstances might affect data processing capabilities
1. Technical and Organizational Measures: Detailed description of security measures, including specific requirements for clinical trial data
2. Data Processing Activities: Detailed list of processing activities, purposes, and data categories
3. Authorized Sub-processors: List of approved sub-processors and their roles in data processing
4. Transfer Impact Assessment: Assessment of risks and safeguards for data transfers
5. Security Breach Response Plan: Detailed procedures for handling data breaches
6. Data Retention Schedule: Specific retention periods for different categories of trial data
7. Standard Contractual Clauses: If applicable, EU SCCs for international transfers
8. Contact Details and Escalation Procedures: List of key contacts and escalation procedures for both parties
Authors
Relevant legal definitions
Clauses
Relevant Industries
Pharmaceuticals
Healthcare
Biotechnology
Medical Devices
Clinical Research
Healthcare Technology
Life Sciences
Academic Research
Contract Research
Data Management
Relevant Teams
Legal
Clinical Operations
Data Protection
Regulatory Affairs
Information Security
Clinical Research
Compliance
Quality Assurance
Research Ethics
Clinical Data Management
Medical Affairs
Privacy
Contract Management
Research Administration
Relevant Roles
Clinical Trial Manager
Data Protection Officer
Legal Counsel
Clinical Research Associate
Regulatory Affairs Manager
Clinical Operations Director
Information Security Officer
Privacy Manager
Research Director
Clinical Data Manager
Compliance Officer
Chief Medical Officer
Clinical Project Manager
Research Ethics Coordinator
Quality Assurance Manager
Find the exact document you need
Clinical Site Agreement
Danish-law governed agreement establishing the framework for conducting clinical trials at healthcare institutions, ensuring compliance with local and EU regulations.
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Data Transfer Agreement Clinical Trial
Danish-law governed Data Transfer Agreement for clinical trials, ensuring GDPR and local regulatory compliance for transfer of clinical trial data.
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