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Data Transfer Agreement Clinical Trial

Data Transfer Agreement Clinical Trial Template for Netherlands

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Key Requirements PROMPT example:

Data Transfer Agreement Clinical Trial

"I need a Data Transfer Agreement Clinical Trial under Dutch law for a multi-center breast cancer study starting March 2025, where our academic medical center will be transferring pseudonymized patient data to three pharmaceutical companies in the Netherlands and Germany."

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Document background
This Data Transfer Agreement Clinical Trial template is designed for use in the Netherlands when establishing formal arrangements for the transfer of clinical trial data between parties involved in medical research. It is particularly relevant when sharing sensitive patient data between research institutions, pharmaceutical companies, hospitals, and other stakeholders in clinical trials. The agreement ensures compliance with the EU GDPR, Dutch GDPR Implementation Act (UAVG), Dutch Medical Research Involving Human Subjects Act (WMO), and EU Clinical Trials Regulation. It should be used whenever clinical trial data needs to be transferred between parties, whether for multi-center studies, collaborative research, or when engaging third-party service providers. The document includes comprehensive provisions for data protection, security measures, breach notifications, and specific clinical trial requirements under Dutch law.
Suggested Sections

1. Parties: Identification of the data transferor and recipient, including their legal status and registered addresses

2. Background: Context of the clinical trial, purpose of data transfer, and relationship between parties

3. Definitions: Definitions of key terms, including technical, regulatory, and trial-specific terminology

4. Subject Matter and Scope: Details of the clinical trial, types of data to be transferred, and purpose of processing

5. Roles and Responsibilities: Clear designation of roles (controller/processor) and respective responsibilities under GDPR

6. Data Protection Principles: Commitment to GDPR principles and specific measures for ensuring compliance

7. Security Measures: Technical and organizational measures for data protection

8. Data Transfer Mechanisms: Methods and protocols for secure data transfer

9. Confidentiality: Obligations regarding confidentiality of trial data and participant information

10. Breach Notification: Procedures for handling and reporting data breaches

11. Term and Termination: Duration of the agreement and conditions for termination

12. Post-Termination Obligations: Handling of data after agreement termination

13. Governing Law and Jurisdiction: Specification of Dutch law and jurisdiction

Optional Sections

1. Sub-processors: Include when third-party data processors will be involved in data processing

2. International Transfers: Required when data will be transferred outside the EEA

3. Audit Rights: Detailed audit provisions when required by the data transferor

4. Insurance and Liability: Specific insurance requirements and liability caps if needed

5. Publication Rights: Terms for publishing trial results when applicable

6. Intellectual Property Rights: When data processing may generate IP rights

7. Cost Allocation: Include when there are specific costs associated with data transfer or processing

Suggested Schedules

1. Schedule 1: Description of Data Processing: Detailed description of data types, processing purposes, and categories of data subjects

2. Schedule 2: Technical and Organizational Measures: Specific security measures and protocols for data protection

3. Schedule 3: Transfer Protocols: Technical specifications for data transfer methods

4. Schedule 4: Contact Details: List of key contacts for operational and emergency matters

5. Schedule 5: Trial Protocol Reference: Reference to or summary of relevant clinical trial protocol elements

6. Appendix A: Data Flow Diagram: Visual representation of data flows between parties

7. Appendix B: Breach Response Plan: Detailed procedures for handling data breaches

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

Linkedin in social icon imageX social icon image
alex.den.21@genieai.co
Relevant legal definitions
Agreement
Applicable Data Protection Laws
Authorized Personnel
Clinical Trial
Clinical Trial Protocol
Confidential Information
Controller
Data Subject
Data Transfer
Effective Date
Good Clinical Practice
Investigation Site
Investigator
Personal Data
Personal Data Breach
Processor
Processing
Pseudonymization
Research Institution
Research Subject
Security Measures
Sensitive Personal Data
Special Categories of Personal Data
Study Data
Sub-processor
Technical and Organizational Measures
Third Party
Trial Participant
Trial Subject Data
Transfer Protocols
WMO
UAVG
GDPR
Regulatory Authority
Sponsor
CRO
Data Protection Impact Assessment
Data Protection Officer
EEA
ICH-GCP
Informed Consent
Subject Identification Code
Trial Master File
Serious Adverse Event
Source Data
Study Protocol
Clauses
Definitions
Data Protection
Confidentiality
Regulatory Compliance
Clinical Trial Protocols
Data Security
Transfer Mechanisms
Breach Notification
Access Rights
Audit Rights
Liability
Indemnification
Insurance
Term and Termination
Force Majeure
Assignment
Sub-processing
International Transfer
Dispute Resolution
Governing Law
Amendment
Severability
Entire Agreement
Notices
Warranties
Publication Rights
Intellectual Property
Record Retention
Emergency Measures
Compliance with Laws
Data Subject Rights
Reporting Obligations
Risk Allocation
Storage and Security
Quality Assurance
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Research

Clinical Research

Data Management

Healthcare Technology

Academic Research

Contract Research

Relevant Teams

Legal

Clinical Operations

Data Management

Regulatory Affairs

Research & Development

Information Security

Compliance

Clinical Research

Privacy & Data Protection

Medical Affairs

Relevant Roles

Clinical Research Director

Data Protection Officer

Clinical Trial Manager

Research Coordinator

Legal Counsel

Privacy Officer

Clinical Operations Manager

Research Ethics Officer

Clinical Data Manager

Regulatory Affairs Manager

Principal Investigator

Clinical Research Associate

Information Security Officer

Compliance Manager

Medical Director

Industries
GDPR (General Data Protection Regulation): EU regulation 2016/679 governing personal data protection and privacy, particularly relevant for handling patient data in clinical trials
Dutch GDPR Implementation Act (UAVG): Dutch national law implementing GDPR, with specific provisions for processing health data
EU Clinical Trials Regulation: Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, including provisions on data handling
Dutch Medical Research Involving Human Subjects Act (WMO): National law governing medical research involving human subjects, including requirements for data handling in clinical trials
Medical Treatment Contracts Act (WGBO): Dutch law regulating medical treatment agreements and medical data handling
ICH-GCP Guidelines: International Conference on Harmonisation - Good Clinical Practice guidelines, setting standards for clinical trials including data management
ISO 14155:2020: International standard for clinical investigation of medical devices for human subjects, including data handling requirements
Dutch Medicines Act: National law governing medicinal products and clinical research, including provisions on data handling
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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