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Research Data Sharing Agreement
"I need a Research Data Sharing Agreement between Trinity College Dublin and a pharmaceutical company for sharing anonymized clinical trial data, with provisions for international transfers and commercial exploitation of research findings."
1. Parties: Identification of all parties to the agreement, including their legal status and registered addresses
2. Background: Context of the research project and purpose of the data sharing arrangement
3. Definitions: Definitions of key terms, including types of data, processing activities, and relevant technical terms
4. Purpose and Scope: Detailed description of the research project and specific purposes for which data will be shared
5. Data Protection Compliance: GDPR and Irish Data Protection Act compliance measures, including lawful basis for processing
6. Roles and Responsibilities: Clear designation of each party's roles (e.g., data controller, processor) and specific responsibilities
7. Data Sharing Protocol: Specific procedures for sharing data, including format, timing, and transmission methods
8. Security Measures: Required technical and organizational security measures for data protection
9. Confidentiality: Confidentiality obligations and restrictions on data use
10. Intellectual Property Rights: Ownership and usage rights of the shared data and research outputs
11. Duration and Termination: Agreement duration, renewal terms, and termination provisions
12. Liability and Indemnities: Allocation of risks and responsibilities between parties
13. Dispute Resolution: Procedures for handling disputes and applicable jurisdiction
14. General Provisions: Standard boilerplate clauses including notices, amendments, and governing law
1. Special Categories of Personal Data: Additional provisions when sharing sensitive personal data or health research data
2. International Transfer Mechanisms: Required when data is transferred outside the EEA, including standard contractual clauses
3. Publication Rights: Terms governing the publication of research results, typically included for academic research
4. Funding Requirements: Specific obligations related to research funding bodies
5. Ethics Committee Approval: Reference to and conditions of ethics committee approvals when required
6. Commercial Exploitation: Terms regarding commercial use of research outputs, if applicable
7. Data Subject Rights: Specific procedures for handling data subject requests when personal data is involved
8. Insurance Requirements: Specific insurance obligations for high-risk research projects
1. Schedule 1 - Data Description: Detailed description of the data sets to be shared, including data fields and formats
2. Schedule 2 - Technical and Security Requirements: Specific technical requirements for data transfer, storage, and security
3. Schedule 3 - Data Processing Activities: Detailed description of all processing activities to be carried out
4. Schedule 4 - Key Contacts: List of key personnel and their roles in the data sharing arrangement
5. Schedule 5 - Data Retention Schedule: Specific timeframes for data retention and deletion requirements
6. Appendix A - Data Protection Impact Assessment: Summary or full DPIA if required for the research project
7. Appendix B - Security Incident Response Plan: Procedures for handling data breaches and security incidents
8. Appendix C - Standard Contractual Clauses: If required for international transfers outside the EEA
Authors
Life Sciences
Healthcare
Biotechnology
Information Technology
Education
Pharmaceuticals
Medical Research
Environmental Science
Data Analytics
Artificial Intelligence
Clinical Research
Public Health
Social Sciences
Agricultural Science
Legal
Research & Development
Data Protection
Information Security
Compliance
Information Technology
Research Operations
Clinical Operations
Data Management
Scientific Affairs
Regulatory Affairs
Ethics Committee
Information Governance
Research Director
Data Protection Officer
Chief Scientific Officer
Research Project Manager
Legal Counsel
Compliance Manager
Chief Information Security Officer
Research Ethics Officer
Principal Investigator
Research Administrator
Information Governance Manager
Research Compliance Officer
Clinical Research Coordinator
Data Manager
Research Department Head
Chief Technology Officer
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