Data Transfer Agreement Clinical Trial Template for Ireland

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Key Requirements PROMPT example:

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."

Document background
The Data Transfer Agreement Clinical Trial is essential for organizations conducting clinical trials in Ireland that need to transfer clinical trial data between different entities. This agreement is specifically designed to comply with Irish data protection laws, EU GDPR requirements, and the Clinical Trials Regulation (EU) No 536/2014. It is typically used when clinical trial data needs to be shared between sponsors, research organizations, healthcare institutions, and data processors. The document includes comprehensive provisions for data security, subject rights protection, breach notification procedures, and specific requirements for handling sensitive health data in clinical trial contexts. It addresses both domestic Irish requirements and international standards for clinical trial data management, making it suitable for both local and cross-border clinical trials involving Irish institutions or subjects.
Suggested Sections

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

Optional Sections

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

Suggested Schedules

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

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Relevant legal definitions
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Life Sciences

Research & Development

Healthcare Data Management

Medical Research

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Data Protection

Clinical Research

Information Security

Quality Assurance

Research Ethics

Compliance

Clinical Data Management

Medical Affairs

Research Administration

Relevant Roles

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

Industries
Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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