The Data Transfer Agreement Clinical Trial is essential when conducting clinical research involving multiple parties in the United States. This document is required whenever clinical trial data needs to be shared between sponsors, research institutions, CROs, and other stakeholders. It ensures compliance with federal regulations including HIPAA and FDA requirements, while establishing clear protocols for data handling, security measures, and privacy protection. The agreement is particularly crucial given the sensitive nature of clinical trial data and the strict regulatory environment governing human subject research in the U.S.
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1. Parties: Identification of data controller, processor, and other relevant parties
2. Background: Context of the clinical trial and purpose of data transfer
3. Definitions: Key terms used throughout the agreement including regulatory references to HIPAA, Common Rule, FDA regulations, and HITECH Act
4. Scope of Data Transfer: Specific data elements to be transferred and permitted uses
5. Data Protection Obligations: Security measures and compliance requirements including HIPAA compliance measures
6. Confidentiality: Provisions for maintaining confidentiality of trial data and subject information
7. Data Security Requirements: Technical and organizational measures required for data protection
8. Term and Termination: Duration of the agreement and conditions for termination
9. Governing Law and Jurisdiction: Applicable US laws and jurisdiction for dispute resolution
1. International Transfer Provisions: Additional provisions for cross-border data transfers, including GDPR compliance if applicable
2. Subprocessor Requirements: Terms and conditions for engaging third-party data processors
3. State-Specific Requirements: Additional requirements based on specific state laws where trial sites are located
4. Breach Notification Procedures: Detailed procedures for handling and reporting data breaches
1. Schedule A - Data Processing Details: Detailed description of data elements and processing activities
2. Schedule B - Security Requirements: Specific technical and organizational measures for data protection
3. Schedule C - Study Protocol Reference: Reference to the clinical trial protocol governing data collection
4. Schedule D - Standard Contractual Clauses: Standard clauses for international data transfers if applicable
5. Schedule E - Data Retention Schedule: Timeframes for data retention and destruction requirements
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