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Data Transfer Agreement Clinical Trial
"I need a Data Transfer Agreement Clinical Trial for transferring patient data between our pharmaceutical company in Dublin and a Contract Research Organization in Germany, starting March 2025, with specific provisions for GDPR compliance and pseudonymization requirements."
1. Parties: Identification of the data exporter and data importer, including their roles and contact details
2. Background: Context of the clinical trial, purpose of data transfer, and relationship between parties
3. Definitions: Definitions of key terms including clinical trial data, personal data, processing, transfer, applicable laws
4. Scope and Purpose of Transfer: Detailed description of the data to be transferred, purpose of transfer, and clinical trial protocol reference
5. Legal Basis for Transfer: Legal grounds for data transfer under GDPR and Clinical Trials Regulation
6. Obligations of Data Exporter: Responsibilities of the sending party including data quality, consent management, and compliance
7. Obligations of Data Importer: Responsibilities of the receiving party including data protection, processing limitations, and security measures
8. Data Security Measures: Technical and organizational measures for protecting clinical trial data
9. Data Subject Rights: Procedures for handling data subject requests and ensuring rights under GDPR
10. Breach Notification: Procedures for reporting and handling data breaches
11. Term and Termination: Duration of agreement and termination provisions
12. Return or Destruction of Data: Obligations regarding data handling upon termination
13. Governing Law and Jurisdiction: Specification of Irish law and jurisdiction
1. Sub-processing: Include when data importer may need to engage sub-processors for data processing
2. Cross-border Transfers: Include when data will be transferred outside the EEA
3. Audit Rights: Include when regular audits of data processing activities are required
4. Compensation and Liability: Include when specific liability arrangements need to be detailed
5. Insurance Requirements: Include when specific insurance coverage for data protection is needed
6. Clinical Trial Specific Provisions: Include when specific trial protocol requirements affect data handling
7. Emergency Protocols: Include when handling urgent medical situations requiring expedited data transfer
1. Schedule 1 - Description of Transfer: Detailed description of data types, transfer methods, and security measures
2. Schedule 2 - Technical and Organizational Measures: Detailed security and organizational measures for data protection
3. Schedule 3 - Authorized Sub-processors: List of approved sub-processors and their roles if applicable
4. Schedule 4 - Transfer Impact Assessment: Assessment of risks and safeguards for data transfer
5. Appendix A - Data Fields: Specific list of data fields to be transferred
6. Appendix B - Clinical Trial Protocol Reference: Reference to relevant clinical trial protocol sections
7. Appendix C - Contact Points: List of key contacts for data protection and trial coordination
8. Appendix D - Standard Contractual Clauses: If needed for international transfers outside EEA
Authors
Applicable Law
Authorized Personnel
Breach of Security
Clinical Trial
Clinical Trial Data
Clinical Trial Protocol
Clinical Trial Subject
Confidential Information
Consent
Controller
Data Protection Laws
Data Protection Officer
Data Subject
Data Subject Rights
Effective Date
GDPR
Good Clinical Practice
Health Data
Irish Data Protection Act
Local Laws
Personal Data
Personal Data Breach
Processing
Processor
Pseudonymisation
Receiving Party
Regulatory Authority
Research Institution
Sensitive Personal Data
Services
Special Categories of Personal Data
Sponsor
Standard Contractual Clauses
Sub-processor
Technical and Organizational Measures
Term
Third Country
Transfer
Transfer Impact Assessment
Trial Site
Transferring Party
Confidentiality
Regulatory Compliance
Subject Rights
Data Security
Transfer Mechanisms
Breach Notification
Liability
Indemnification
Audit Rights
Sub-processing
Cross-border Transfer
Clinical Trial Compliance
Term and Termination
Force Majeure
Governing Law
Dispute Resolution
Assignment
Severability
Entire Agreement
Amendments
Notices
Warranties
Insurance
Data Retention
Emergency Protocols
Intellectual Property
Publication Rights
Ethics Committee Compliance
Record Keeping
Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Clinical Research
Healthcare Technology
Life Sciences
Research & Development
Healthcare Data Management
Medical Research
Legal
Clinical Operations
Regulatory Affairs
Data Protection
Clinical Research
Information Security
Quality Assurance
Research Ethics
Compliance
Clinical Data Management
Medical Affairs
Research Administration
Clinical Trial Manager
Data Protection Officer
Clinical Research Director
Legal Counsel
Regulatory Affairs Manager
Clinical Operations Manager
Research Ethics Officer
Clinical Data Manager
Compliance Officer
Principal Investigator
Clinical Research Coordinator
Information Security Manager
Medical Director
Quality Assurance Manager
Research Administrator
Clinical Trial Monitor
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