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Research Data Sharing Agreement
"I need a Research Data Sharing Agreement for sharing clinical trial data between our pharmaceutical company and a university research center in Mumbai, with strict confidentiality provisions and ethics committee requirements, planned to commence in March 2025."
1. Parties: Identification of the data provider and recipient organizations, 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 used in the agreement, including 'Research Data', 'Confidential Information', 'Intellectual Property Rights', etc.
4. Scope of Agreement: Details of the research data to be shared and the permitted purposes for its use
5. Data Transfer and Access: Mechanisms and protocols for transferring and accessing the research data
6. Data Security and Protection: Required security measures, compliance with DPDP Act 2023 and other applicable laws
7. Confidentiality Obligations: Obligations regarding confidentiality and restrictions on data disclosure
8. Intellectual Property Rights: Ownership and rights related to the research data and derived works
9. Publication Rights: Terms governing the publication of research results using the shared data
10. Term and Termination: Duration of the agreement and circumstances for termination
11. Return or Destruction of Data: Obligations regarding data handling upon termination
12. Governing Law and Jurisdiction: Specification of Indian law as governing law and jurisdiction for disputes
1. Commercial Terms: Include when there are fees or costs associated with data sharing
2. Third Party Rights: Include when the data involves third-party rights or when third parties may access the data
3. Insurance and Liability: Include when specific insurance requirements or liability limitations are needed
4. Ethics Committee Approval: Include for medical or human subject research data
5. Data Protection Impact Assessment: Include when sharing sensitive personal data or large-scale data processing
6. International Transfer Provisions: Include when data will be transferred outside India
7. Dispute Resolution: Include when specific arbitration or mediation procedures are desired
1. Schedule 1 - Description of Research Data: Detailed description of the research data sets, formats, and metadata
2. Schedule 2 - Technical Requirements: Technical specifications for data transfer, storage, and security measures
3. Schedule 3 - Authorized Users: List of authorized personnel who may access the research data
4. Schedule 4 - Data Processing Protocols: Specific protocols and standards for handling and processing the data
5. Appendix A - Data Security Standards: Detailed security requirements and compliance standards
6. Appendix B - Publication Review Process: Procedures for reviewing and approving publications using the shared data
7. Appendix C - Data Destruction Certificate: Template certificate for confirming data destruction upon termination
Authors
Healthcare and Life Sciences
Information Technology
Pharmaceuticals
Biotechnology
Environmental Sciences
Agricultural Research
Education and Academia
Energy and Utilities
Manufacturing
Defense and Aerospace
Social Sciences
Market Research
Legal
Research and Development
Data Protection
Information Security
Compliance
Academic Affairs
Scientific Operations
Intellectual Property
Information Technology
Research Ethics
Data Management
Clinical Operations
Research Director
Chief Scientific Officer
Data Protection Officer
Legal Counsel
Research Compliance Manager
Principal Investigator
Research Project Manager
Information Security Manager
Chief Technology Officer
Research Ethics Officer
Data Manager
Academic Dean
Research Administrator
Intellectual Property Manager
Chief Research Officer
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