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Data Transfer Agreement Clinical Trial
"I need a Data Transfer Agreement Clinical Trial for a multi-center phase III trial starting in March 2025, where our Swiss pharmaceutical company will be transferring patient data to three research sites and a central laboratory, with specific provisions for handling genetic data."
1. Parties: Identification of the data transferor and transferee, including full legal names and addresses
2. Background: Context of the clinical trial, purpose of data transfer, and relationship between parties
3. Definitions: Key terms including Clinical Trial Data, Personal Data, Processing, Transfer, Security Measures, and other relevant terminology
4. Scope and Purpose of Transfer: Detailed description of what data will be transferred and for what specific purposes
5. Compliance with Laws: Obligations to comply with Swiss data protection laws, clinical trial regulations, and other applicable legislation
6. Data Protection Obligations: Specific obligations regarding data protection, including security measures, confidentiality, and data subject rights
7. Transfer Mechanisms: Technical and organizational measures for secure data transfer
8. Security Requirements: Detailed security measures required for data protection
9. Confidentiality: Confidentiality obligations regarding the transferred data
10. Duration and Termination: Term of the agreement and termination provisions
11. Return or Destruction of Data: Obligations regarding data handling upon termination
12. Liability and Indemnification: Allocation of risks and responsibilities between parties
13. General Provisions: Standard contractual clauses including governing law, jurisdiction, and amendment procedures
1. Sub-processing: Include when the transferee may need to engage sub-processors for data handling
2. Cross-border Transfers: Include when data will be transferred outside Switzerland
3. Audit Rights: Include when regular auditing of data handling practices is required
4. Insurance: Include when specific insurance coverage for data-related risks is required
5. Data Breach Notification: Include detailed breach notification procedures when handling sensitive clinical data
6. Intellectual Property Rights: Include when there are specific IP considerations regarding the data or derived analyses
7. Publication Rights: Include when clinical trial results may be published
1. Description of Data: Detailed specification of the clinical trial data to be transferred
2. Technical Security Measures: Detailed technical requirements for data security and transfer
3. Data Processing Activities: Detailed description of all processing activities to be performed
4. Contact Details: List of key contacts including data protection officers and technical contacts
5. Transfer Timeline: Schedule of data transfers and related milestones
6. Data Retention Schedule: Specific requirements for data retention and deletion
7. Standard Contractual Clauses: If applicable, for international transfers
Authors
Healthcare
Pharmaceuticals
Biotechnology
Clinical Research
Medical Devices
Healthcare Technology
Life Sciences
Medical Research
Data Management
Legal
Clinical Operations
Regulatory Affairs
Data Management
Information Security
Quality Assurance
Clinical Research
Compliance
Research & Development
Information Technology
Privacy
Contract Management
Clinical Trial Manager
Data Protection Officer
Legal Counsel
Clinical Research Director
Regulatory Affairs Manager
Clinical Operations Manager
Research Coordinator
Compliance Officer
Information Security Manager
Clinical Data Manager
Project Manager
Quality Assurance Manager
Chief Medical Officer
Clinical Research Associate
Data Privacy Manager
Contract Manager
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