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Data Transfer Agreement Clinical Trial

Data Transfer Agreement Clinical Trial Template for Austria

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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 Vienna-based research hospital and a pharmaceutical company in Switzerland, starting March 2025, with special attention to cross-border data protection requirements and specific provisions for handling genetic data."

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Document background
The Data Transfer Agreement Clinical Trial is essential for organizations conducting clinical research in Austria that involves the transfer of patient data and trial-related information between different entities. This agreement type is specifically designed to comply with Austrian legal requirements while adhering to broader EU regulations, including GDPR and the Clinical Trials Regulation (EU) No 536/2014. It becomes necessary when clinical trial data needs to be shared between sponsors, research institutions, CROs, and other stakeholders while maintaining strict data protection standards. The document addresses critical aspects such as data security measures, participant privacy rights, breach notification procedures, and specific obligations of each party involved in the data transfer process. It's particularly relevant in the context of multi-center trials, international research collaborations, and situations where third-party data processors are involved in handling clinical trial information.
Suggested Sections

1. Parties: Identification of the data controller(s), data processor(s), and any other relevant parties including sponsor, research institution, and participating sites

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

3. Definitions: Definitions of key terms including types of data, processing activities, and clinical trial specific terminology

4. Scope and Purpose: Detailed description of data transfer activities, purposes, and limitations

5. Data Protection Obligations: GDPR and Austrian law compliance requirements, including legal basis for processing and transfer

6. Security Measures: Technical and organizational measures for protecting clinical trial data during transfer and storage

7. Data Subject Rights: Procedures for handling data subject requests and maintaining trial participant rights

8. Confidentiality: Confidentiality obligations regarding trial data, patient information, and related confidential information

9. Duration and Termination: Term of the agreement, termination conditions, and data handling post-termination

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

11. Governing Law and Jurisdiction: Specification of Austrian law governance and jurisdiction arrangements

Optional Sections

1. International Transfers: Required when data transfers occur outside the EEA, including standard contractual clauses

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

3. Insurance: Required when specific insurance arrangements for data protection incidents need to be specified

4. Audit Rights: Detailed audit provisions when regular auditing is required beyond standard compliance checks

5. Emergency Protocols: Include for high-risk trials requiring specific emergency data handling procedures

6. Publication Rights: Include when addressing rights to publish trial results and related data

7. Intellectual Property: Required when specific IP rights in relation to the data need to be addressed

Suggested Schedules

1. Description of Data Processing: Detailed description of data types, processing operations, and purposes

2. Security Measures: Technical specifications of security measures and protocols

3. Transfer Mechanisms: Technical details of data transfer methods and systems

4. Contact Details: List of key contacts including data protection officers and trial coordinators

5. Standard Contractual Clauses: EU approved SCCs if required for international transfers

6. Data Breach Protocol: Detailed procedures for handling and reporting data breaches

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

8. Compliance Checklist: Checklist ensuring compliance with GDPR and Austrian data protection requirements

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
Austrian Data Protection Act
Clinical Trial
Clinical Trial Protocol
Confidential Information
Controller
Data Subject
Data Transfer
EEA
Effective Date
EU GDPR
Force Majeure
Good Clinical Practice
Personal Data
Personal Data Breach
Processor
Processing
Protected Health Information
Pseudonymization
Receiving Party
Research Institution
Security Measures
Sensitive Personal Data
Services
Site
Sponsor
Study
Study Data
Study Participant
Sub-processor
Technical and Organizational Measures
Term
Third Party
Transfer Mechanisms
Trial Subject
Transferring Party
Working Day
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Life Sciences

Research & Development

Data Management

Medical Laboratory Services

Relevant Teams

Legal

Clinical Operations

Data Management

Regulatory Affairs

Compliance

Research & Development

Information Security

Clinical Research

Privacy

Contract Management

Medical Affairs

Quality Assurance

Relevant Roles

Clinical Trial Manager

Data Protection Officer

Legal Counsel

Clinical Research Director

Regulatory Affairs Manager

Clinical Operations Manager

Research Coordinator

Compliance Officer

Medical Director

Clinical Data Manager

Contract Manager

Privacy Officer

Research Ethics Officer

Clinical Project Manager

Information Security Officer

Industries
EU GDPR: General Data Protection Regulation (2016/679) - Fundamental EU law governing personal data processing and transfer, particularly relevant for handling patient data in clinical trials
Austrian Data Protection Act (DSG): National implementation of GDPR and additional data protection requirements specific to Austria
EU Clinical Trials Regulation: Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, providing framework for conducting clinical trials in the EU
Austrian Medicines Act (Arzneimittelgesetz - AMG): National law governing medicinal products and clinical trials in Austria, including specific provisions for data handling in clinical research
Austrian Hospitals Act (Krankenanstaltengesetz - KAG): Regulations concerning hospital operations and medical data handling in hospital settings
Austrian Research Organisation Act (FOG): Framework for research organizations and their data handling obligations in Austria
EU GCP Guidelines: Good Clinical Practice guidelines that ensure ethical and scientific quality standards in clinical trials
Austrian Medical Devices Act (Medizinproduktegesetz): Relevant if the clinical trial involves medical devices, including provisions for data collection and 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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