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Confidential Disclosure Agreement In Clinical Research

Confidential Disclosure Agreement In Clinical Research Template for England and Wales

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Key Requirements PROMPT example:

Confidential Disclosure Agreement In Clinical Research

"I need a Confidential Disclosure Agreement In Clinical Research between our pharmaceutical company and Oxford University for a Phase II cancer drug trial, with specific provisions for handling genetic data and potential IP rights from discoveries made during the research, starting March 2025."

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Document background
A Confidential Disclosure Agreement In Clinical Research is essential when parties need to share sensitive information during clinical trials or medical research. This agreement, governed by English and Welsh law, provides a framework for protecting proprietary information, research data, and intellectual property while ensuring compliance with UK GDPR, Clinical Trials Regulations, and healthcare industry standards. It's particularly crucial when sharing patient data, research methodologies, or preliminary results between research institutions, pharmaceutical companies, or healthcare providers.
Suggested Sections

1. Parties: Identification and details of the disclosing and receiving parties

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

3. Definitions: Key terms including Confidential Information, Clinical Data, Study, etc.

4. Scope of Confidential Information: Detailed description of what constitutes confidential information

5. Permitted Use: Specific purposes for which confidential information may be used

6. Confidentiality Obligations: Core obligations regarding protection and non-disclosure

7. Term and Termination: Duration of agreement and termination provisions

8. Return or Destruction of Information: Procedures for handling confidential information after termination

9. Governing Law and Jurisdiction: Specification of applicable law and courts

Optional Sections

1. Data Protection Compliance: Additional provisions for GDPR and data protection obligations when personal data is involved

2. Publication Rights: Provisions regarding rights to publish research findings, typically used for academic or research institution agreements

3. Third Party Disclosure: Rules for sharing with authorized third parties, used when subcontractors or affiliates need access

4. Intellectual Property Rights: Provisions covering ownership and rights in research outcomes when research might generate IP

5. Security Measures: Specific security requirements for highly sensitive data

Suggested Schedules

1. Description of Research Project: Detailed outline of the clinical research

2. Categories of Confidential Information: Specific listing of confidential information types

3. Authorized Recipients: List of individuals/roles authorized to access information

4. Security Protocols: Detailed security measures and procedures

5. Data Processing Terms: Detailed data protection obligations if applicable

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
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UK GDPR: UK General Data Protection Regulation - Primary legislation governing the processing and protection of personal data in the UK post-Brexit

Data Protection Act 2018: UK's implementation of data protection laws, working alongside UK GDPR to regulate personal data processing and protection

PECR: Privacy and Electronic Communications Regulations - Specific rules for electronic communications, marketing, and cookies

MHRA Guidelines: Medicines and Healthcare products Regulatory Agency guidelines governing clinical trials and healthcare research in the UK

Human Medicines Regulations 2012: Regulations governing the licensing, manufacture, and supply of medicines, including requirements for clinical trials

Clinical Trials Regulation EU 536/2014: Retained EU law governing clinical trials, establishing standards for conducting clinical research

Patents Act 1977: Primary legislation governing patent rights and intellectual property protection in the UK

Copyright, Designs and Patents Act 1988: Legislation protecting intellectual property rights including copyright and design rights

Trade Secrets Regulations 2018: Regulations protecting confidential business information and providing remedies for trade secret misappropriation

Human Tissue Act 2004: Legislation regulating the storage and use of human tissue in research and other purposes

Mental Capacity Act 2005: Law governing decision-making on behalf of adults who lack capacity, including participation in research

HRA Requirements: Health Research Authority requirements for conducting research in the UK healthcare system

Law of Confidence: Common law principles protecting confidential information and establishing duties of confidence

GCP Guidelines: Good Clinical Practice guidelines establishing international quality standards for clinical research

Research Ethics Committee Requirements: Ethical standards and requirements for conducting clinical research, including confidentiality obligations

NHS Research Governance: Framework governing research conducted within or affecting the National Health Service

ICH Guidelines: International Conference on Harmonisation guidelines providing global standards for clinical research

Declaration of Helsinki: World Medical Association's statement of ethical principles for medical research involving human subjects

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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