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Confidential Disclosure Agreement In Clinical Research

Confidential Disclosure Agreement In Clinical Research Template for New Zealand

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Key Requirements PROMPT example:

Confidential Disclosure Agreement In Clinical Research

"I need a Confidential Disclosure Agreement in Clinical Research for a Phase II clinical trial of a new diabetes medication, where our pharmaceutical company will be sharing confidential trial protocols with three research sites in Auckland, starting March 2025."

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Document background
The Confidential Disclosure Agreement In Clinical Research is essential for organizations conducting clinical research in New Zealand where sensitive information needs to be shared between multiple parties. This agreement is typically used when initiating clinical trials, collaborative research projects, or when sharing research methodologies and results. It ensures compliance with New Zealand's Privacy Act 2020, Health Information Privacy Code 2020, and relevant healthcare regulations. The document covers the handling of confidential information including but not limited to patient data, research protocols, trial results, proprietary methodologies, and intellectual property. It is particularly crucial in early-stage research discussions, partnership evaluations, and throughout the duration of clinical trials.
Suggested Sections

1. Parties: Identification of the disclosing party (typically the research organization) and receiving party, including full legal names and addresses

2. Background: Context of the clinical research project and purpose of sharing confidential information

3. Definitions: Detailed definitions including 'Confidential Information', 'Clinical Research', 'Research Project', 'Authorized Personnel', and other key terms

4. Scope of Confidential Information: Detailed description of what constitutes confidential information in the clinical research context

5. Obligations of Confidentiality: Core confidentiality obligations, including storage, handling, and protection requirements

6. Permitted Use and Disclosure: Specific allowed uses of confidential information and circumstances under which disclosure is permitted

7. Security Measures: Required security protocols for protecting confidential information

8. Duration of Confidentiality: Time period for which confidentiality obligations remain in effect

9. Return or Destruction of Confidential Information: Procedures for handling confidential information after agreement termination

10. Breach and Remedies: Consequences of breach and available remedies

11. General Provisions: Standard clauses including governing law, jurisdiction, and entire agreement

Optional Sections

1. Intellectual Property Rights: Specific provisions regarding IP rights when the clinical research may lead to patentable discoveries

2. Publication Rights: Used when research results may be published, outlining review and approval processes

3. Third Party Disclosure: Additional provisions for cases where third-party contractors or affiliates need access to information

4. International Transfer of Data: Required when confidential information will be transferred across borders

5. Clinical Trial Specific Provisions: Additional provisions specific to clinical trial protocols and requirements

6. Data Protection Officer: Designation of responsible persons when handling large amounts of sensitive data

7. Insurance and Indemnification: Additional protection clauses for high-risk research scenarios

Suggested Schedules

1. Schedule 1 - Description of Research Project: Detailed description of the clinical research project and its objectives

2. Schedule 2 - Authorized Personnel: List of individuals authorized to access confidential information

3. Schedule 3 - Security Protocols: Detailed security requirements and procedures

4. Schedule 4 - Data Handling Procedures: Specific procedures for handling different types of confidential information

5. Appendix A - Forms and Templates: Standard forms for recording disclosure, destruction certificates, etc.

6. Appendix B - Compliance Checklist: Checklist ensuring compliance with relevant regulations and standards

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈË°æ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co
Relevant legal definitions






























Clauses






























Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Academic Research

Life Sciences

Healthcare Technology

Public Health

Medical Education

Relevant Teams

Legal

Clinical Operations

Research and Development

Regulatory Affairs

Compliance

Data Protection

Medical Affairs

Clinical Trials

Information Security

Ethics Committee

Scientific Affairs

Relevant Roles

Clinical Research Director

Research Project Manager

Chief Medical Officer

Legal Counsel

Compliance Officer

Data Protection Officer

Clinical Trial Coordinator

Principal Investigator

Research Scientist

Regulatory Affairs Manager

Ethics Committee Member

Medical Director

Research and Development Manager

Clinical Operations 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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