The Data Transfer Agreement Clinical Trial is essential for organizations conducting clinical research in Austria that involves the transfer of patient data and trial-related information between different entities. This agreement type is specifically designed to comply with Austrian legal requirements while adhering to broader EU regulations, including GDPR and the Clinical Trials Regulation (EU) No 536/2014. It becomes necessary when clinical trial data needs to be shared between sponsors, research institutions, CROs, and other stakeholders while maintaining strict data protection standards. The document addresses critical aspects such as data security measures, participant privacy rights, breach notification procedures, and specific obligations of each party involved in the data transfer process. It's particularly relevant in the context of multi-center trials, international research collaborations, and situations where third-party data processors are involved in handling clinical trial information.
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1. Parties: Identification of the data controller(s), data processor(s), and any other relevant parties including sponsor, research institution, and participating sites
2. Background: Context of the clinical trial, purpose of data transfer, and relationship between parties
3. Definitions: Definitions of key terms including types of data, processing activities, and clinical trial specific terminology
4. Scope and Purpose: Detailed description of data transfer activities, purposes, and limitations
5. Data Protection Obligations: GDPR and Austrian law compliance requirements, including legal basis for processing and transfer
6. Security Measures: Technical and organizational measures for protecting clinical trial data during transfer and storage
7. Data Subject Rights: Procedures for handling data subject requests and maintaining trial participant rights
8. Confidentiality: Confidentiality obligations regarding trial data, patient information, and related confidential information
9. Duration and Termination: Term of the agreement, termination conditions, and data handling post-termination
10. Liability and Indemnification: Allocation of risks and responsibilities between parties
11. Governing Law and Jurisdiction: Specification of Austrian law governance and jurisdiction arrangements
1. International Transfers: Required when data transfers occur outside the EEA, including standard contractual clauses
2. Sub-processing: Include when third-party data processors will be involved in data processing activities
3. Insurance: Required when specific insurance arrangements for data protection incidents need to be specified
4. Audit Rights: Detailed audit provisions when regular auditing is required beyond standard compliance checks
5. Emergency Protocols: Include for high-risk trials requiring specific emergency data handling procedures
6. Publication Rights: Include when addressing rights to publish trial results and related data
7. Intellectual Property: Required when specific IP rights in relation to the data need to be addressed
1. Description of Data Processing: Detailed description of data types, processing operations, and purposes
2. Security Measures: Technical specifications of security measures and protocols
3. Transfer Mechanisms: Technical details of data transfer methods and systems
4. Contact Details: List of key contacts including data protection officers and trial coordinators
5. Standard Contractual Clauses: EU approved SCCs if required for international transfers
6. Data Breach Protocol: Detailed procedures for handling and reporting data breaches
7. Trial Protocol Reference: Reference to or summary of relevant clinical trial protocol elements
8. Compliance Checklist: Checklist ensuring compliance with GDPR and Austrian data protection requirements
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