This Data Transfer Agreement Clinical Trial template is designed for use in the Netherlands when establishing formal arrangements for the transfer of clinical trial data between parties involved in medical research. It is particularly relevant when sharing sensitive patient data between research institutions, pharmaceutical companies, hospitals, and other stakeholders in clinical trials. The agreement ensures compliance with the EU GDPR, Dutch GDPR Implementation Act (UAVG), Dutch Medical Research Involving Human Subjects Act (WMO), and EU Clinical Trials Regulation. It should be used whenever clinical trial data needs to be transferred between parties, whether for multi-center studies, collaborative research, or when engaging third-party service providers. The document includes comprehensive provisions for data protection, security measures, breach notifications, and specific clinical trial requirements under Dutch law.
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1. Parties: Identification of the data transferor and recipient, including their legal status and registered addresses
2. Background: Context of the clinical trial, purpose of data transfer, and relationship between parties
3. Definitions: Definitions of key terms, including technical, regulatory, and trial-specific terminology
4. Subject Matter and Scope: Details of the clinical trial, types of data to be transferred, and purpose of processing
5. Roles and Responsibilities: Clear designation of roles (controller/processor) and respective responsibilities under GDPR
6. Data Protection Principles: Commitment to GDPR principles and specific measures for ensuring compliance
7. Security Measures: Technical and organizational measures for data protection
8. Data Transfer Mechanisms: Methods and protocols for secure data transfer
9. Confidentiality: Obligations regarding confidentiality of trial data and participant information
10. Breach Notification: Procedures for handling and reporting data breaches
11. Term and Termination: Duration of the agreement and conditions for termination
12. Post-Termination Obligations: Handling of data after agreement termination
13. Governing Law and Jurisdiction: Specification of Dutch law and jurisdiction
1. Sub-processors: Include when third-party data processors will be involved in data processing
2. International Transfers: Required when data will be transferred outside the EEA
3. Audit Rights: Detailed audit provisions when required by the data transferor
4. Insurance and Liability: Specific insurance requirements and liability caps if needed
5. Publication Rights: Terms for publishing trial results when applicable
6. Intellectual Property Rights: When data processing may generate IP rights
7. Cost Allocation: Include when there are specific costs associated with data transfer or processing
1. Schedule 1: Description of Data Processing: Detailed description of data types, processing purposes, and categories of data subjects
2. Schedule 2: Technical and Organizational Measures: Specific security measures and protocols for data protection
3. Schedule 3: Transfer Protocols: Technical specifications for data transfer methods
4. Schedule 4: Contact Details: List of key contacts for operational and emergency matters
5. Schedule 5: Trial Protocol Reference: Reference to or summary of relevant clinical trial protocol elements
6. Appendix A: Data Flow Diagram: Visual representation of data flows between parties
7. Appendix B: Breach Response Plan: Detailed procedures for handling data breaches
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