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Data Transfer Agreement In Clinical Data Management

Data Transfer Agreement In Clinical Data Management Template for Germany

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Key Requirements PROMPT example:

Data Transfer Agreement In Clinical Data Management

"I need a Data Transfer Agreement in Clinical Data Management between our pharmaceutical company based in Munich and three clinical research sites across Germany, to facilitate a multi-center Phase III trial starting in March 2025, with specific provisions for handling genetic data and biomarker samples."

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Document background
A Data Transfer Agreement In Clinical Data Management is essential when organizations need to share or process clinical trial data while maintaining compliance with German and EU regulations. This document is particularly crucial in scenarios involving multi-center clinical trials, collaborative research projects, or outsourced data management services. It addresses the complex requirements of the German Federal Data Protection Act (BDSG), GDPR, and clinical trial regulations, establishing clear protocols for data handling, security measures, and responsibility allocation. The agreement is designed to protect sensitive health data, ensure regulatory compliance, and facilitate efficient clinical research operations while maintaining the highest standards of data protection and patient privacy. It includes specific provisions for data breach notification, audit rights, and technical security measures required under German law.
Suggested Sections

1. Parties: Identification of the contracting parties, including their roles under data protection law (controller/processor)

2. Background: Context of the agreement, including the clinical trial or research project context

3. Definitions: Definitions of key terms used in the agreement, including technical and regulatory terminology

4. Purpose and Scope: Detailed description of the purpose of data transfer and scope of data processing activities

5. Data Protection Compliance: General obligations regarding GDPR and German data protection law compliance

6. Types of Data and Processing Activities: Specification of data categories and permitted processing activities

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

8. Transfer Mechanisms: Procedures and requirements for data transfer, including any cross-border elements

9. Confidentiality: Confidentiality obligations regarding the clinical data and related information

10. Subprocessing: Rules and restrictions regarding the use of subprocessors

11. Data Subject Rights: Procedures for handling data subject requests and rights

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

13. Audit Rights: Rights and procedures for conducting audits of data processing activities

14. Liability and Indemnification: Allocation of risks and responsibilities between parties

15. Term and Termination: Duration of the agreement and termination provisions

16. Post-Termination Obligations: Obligations surviving termination, including data deletion or return

17. Governing Law and Jurisdiction: Specification of German law application and jurisdiction

Optional Sections

1. Emergency Protocols: Special procedures for emergency access to data, used when immediate access might be required for patient safety

2. Cross-Border Transfers: Additional provisions for transfers outside the EU/EEA, needed when data will cross borders

3. Specialized Processing Activities: Additional terms for specific types of processing (e.g., AI/ML analysis), included when relevant to the project

4. Insurance Requirements: Specific insurance obligations, included for high-risk processing activities

5. Data Retention Schedule: Specific retention requirements, included when different from standard clinical trial requirements

6. Regulatory Authority Access: Special provisions for regulatory authority access, included for regulated clinical trials

7. Publication Rights: Terms regarding the publication of research results, included for academic research projects

Suggested Schedules

1. Schedule 1 - Description of Processing Activities: Detailed description of all data processing activities, including data flows and purposes

2. Schedule 2 - Security Measures: Detailed technical and organizational security measures to be implemented

3. Schedule 3 - Approved Subprocessors: List of approved subprocessors and their roles, if any

4. Schedule 4 - Transfer Mechanisms: Detailed transfer procedures and safeguards, including any SCCs

5. Schedule 5 - Data Fields: Specific list of data fields and categories being transferred

6. Schedule 6 - Contact Points: Key contacts for operational, technical, and legal matters

7. Appendix A - Data Breach Response Plan: Detailed procedures for handling data breaches

8. Appendix B - Audit Procedures: Detailed procedures for conducting audits

9. Appendix C - Technical Requirements: Technical specifications for data transfer and storage systems

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈË°æ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co
Relevant legal definitions








































Clauses






























Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Clinical Research

Medical Devices

Healthcare Technology

Life Sciences

Research & Development

Healthcare Analytics

Medical Informatics

Relevant Teams

Legal

Clinical Operations

Data Management

Regulatory Affairs

Information Technology

Quality Assurance

Research & Development

Compliance

Information Security

Clinical Systems

Privacy Office

Medical Affairs

Clinical Informatics

Biostatistics

Relevant Roles

Clinical Data Manager

Data Protection Officer

Clinical Research Associate

Legal Counsel

Privacy Officer

Clinical Operations Director

Regulatory Affairs Manager

Information Security Officer

Clinical Trial Manager

Research Director

Compliance Officer

Clinical Systems Manager

Biostatistician

Clinical Project Manager

Quality Assurance Manager

Medical Director

IT Security Manager

Clinical Database Manager

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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