This Data Transfer Agreement Clinical Trial template is essential for organizations conducting clinical trials in Switzerland that need to transfer clinical trial data between different entities. The document is specifically designed to comply with Swiss regulatory requirements, including the Federal Act on Data Protection, Human Research Act, and Clinical Trials Ordinance. It should be used whenever clinical trial data needs to be shared between parties such as sponsors, CROs, research institutions, or healthcare facilities. The agreement covers crucial aspects including data protection measures, transfer mechanisms, security requirements, and compliance obligations. It is particularly important in the context of multi-center clinical trials, international research collaborations, and situations where clinical trial data processing is outsourced or shared with third parties. The document ensures that all data transfers maintain compliance with Swiss legal requirements while protecting the interests of trial subjects and maintaining data integrity.
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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
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