Confidential Disclosure Agreement In Clinical Research Template for Ireland

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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.

Document background
The Confidential Disclosure Agreement In Clinical Research is a crucial legal instrument used when parties need to share sensitive information in the context of clinical research activities in Ireland. This document is essential when research organizations, pharmaceutical companies, or healthcare institutions need to exchange confidential information such as research protocols, patient data, trial methodologies, or proprietary information. It ensures compliance with Irish legal requirements and EU regulations, including GDPR, the Clinical Trials Regulation, and the Health Research Regulations 2018. The agreement is particularly important in protecting intellectual property rights, maintaining data privacy, and ensuring regulatory compliance while facilitating necessary information sharing for research advancement.
Suggested Sections

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

Optional Sections

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

Suggested Schedules

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

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

Relevant legal definitions
Clauses
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Academic Research

Life Sciences

Healthcare Technology

Medical Diagnostics

Public Health

Laboratory Services

Relevant Teams

Legal

Clinical Operations

Research and Development

Regulatory Affairs

Compliance

Data Protection

Clinical Research

Medical Affairs

Information Security

Intellectual Property

Ethics Committee

Quality Assurance

Relevant Roles

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

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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