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Confidential Disclosure Agreement In Clinical Research
I need a Confidential Disclosure Agreement in Clinical Research under Irish law for a multi-center breast cancer study starting in March 2025, involving three research institutions and a pharmaceutical company, with special emphasis on handling genetic data and international data transfers.
1. Parties: Identification of all parties to the agreement, including full legal names and addresses
2. Background: Context of the agreement, describing the clinical research project and the purpose of information sharing
3. Definitions: Detailed definitions of key terms, especially 'Confidential Information', 'Clinical Data', 'Research Protocol', and other relevant terms
4. Purpose of Disclosure: Specific description of why confidential information needs to be shared and how it will be used
5. Scope of Confidential Information: Detailed description of what constitutes confidential information in the context of the clinical research
6. Obligations of Confidentiality: Core confidentiality obligations, including handling, storage, and protection of confidential information
7. Permitted Disclosures: Circumstances under which confidential information may be disclosed, including to research team members and regulatory authorities
8. Data Protection and GDPR Compliance: Specific provisions relating to handling of personal data and compliance with data protection laws
9. Security Measures: Required security measures for protecting confidential information
10. Return or Destruction of Confidential Information: Procedures for handling confidential information after the agreement ends
11. Term and Termination: Duration of the agreement and circumstances for termination
12. Governing Law and Jurisdiction: Specification of Irish law as governing law and jurisdiction for disputes
13. General Provisions: Standard boilerplate provisions including severability, entire agreement, and amendments
1. Regulatory Compliance: Additional provisions specific to compliance with clinical trial regulations, used when the research involves clinical trials
2. Intellectual Property Rights: Provisions addressing ownership and protection of IP, used when research may generate valuable IP
3. Publication Rights: Provisions regarding rights to publish research results, used when academic institutions are involved
4. Third Party Contractors: Provisions for handling confidential information with third party contractors, used when external vendors or CROs are involved
5. International Transfer of Data: Provisions for international data transfers, used when parties are in different jurisdictions
6. Specific Security Protocols: Detailed security requirements, used when handling particularly sensitive data or when required by specific regulations
7. Insurance and Indemnification: Additional protection provisions, used in high-risk research scenarios
1. Schedule 1 - Description of Clinical Research Project: Detailed description of the research project and its objectives
2. Schedule 2 - Authorized Recipients: List of individuals or roles authorized to receive confidential information
3. Schedule 3 - Security Protocols: Detailed security procedures and requirements
4. Schedule 4 - Data Processing Requirements: Specific requirements for data processing under GDPR
5. Appendix A - Forms and Templates: Standard forms for tracking disclosure and destruction of confidential information
6. Appendix B - Contact Information: Contact details for key personnel responsible for managing confidential information
Authors
Clinical Research
Research Protocol
Study Data
Personal Data
Clinical Trial
Disclosing Party
Receiving Party
Authorized Recipients
Affiliate
Background IP
Clinical Trial Subject
Confidential Disclosure Period
Data Protection Laws
Effective Date
Study Results
Healthcare Professional
Intellectual Property Rights
Investigation Site
Principal Investigator
Project
Purpose
Representatives
Research Institution
Sample
Special Categories of Personal Data
Sponsor
Study
Subject Matter
Technical Information
Term
Territory
Trade Secrets
Trial Protocol
Regulatory Authority
Research Materials
Permitted Purpose
Data Controller
Data Processor
Research Staff
Confidentiality Period
Disclosures Required By Law
Security Measures
Clinical Trial Agreement
Good Clinical Practice
Research Ethics Committee
Study Documentation
Trial Site
Data Protection
Permitted Use
Information Security
Regulatory Compliance
Term and Duration
Return of Information
Destruction of Information
Permitted Disclosures
Breach Notification
Intellectual Property
Publication Rights
Governing Law
Dispute Resolution
Force Majeure
Assignment
Severability
Entire Agreement
Third Party Rights
Notices
Amendment
Waiver
Indemnification
Termination
Survival
Regulatory Reporting
Data Transfer
Research Ethics
Clinical Trial Compliance
Personal Data Processing
Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Clinical Research
Academic Research
Life Sciences
Healthcare Technology
Medical Diagnostics
Public Health
Laboratory Services
Legal
Clinical Operations
Research and Development
Regulatory Affairs
Compliance
Data Protection
Clinical Research
Medical Affairs
Information Security
Intellectual Property
Ethics Committee
Quality Assurance
Clinical Research Director
Research Project Manager
Chief Medical Officer
Legal Counsel
Regulatory Affairs Manager
Clinical Trial Coordinator
Research Scientist
Data Protection Officer
Principal Investigator
Research Ethics Officer
Clinical Operations Manager
Medical Director
Compliance Officer
Research and Development Manager
Clinical Research Associate
Intellectual Property Manager
Information Security Officer
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