Clinical Trial Confidentiality Agreement for the United Kingdom

Clinical Trial Confidentiality Agreement Template for England and Wales

A Clinical Trial Confidentiality Agreement under English and Welsh law is a legally binding document that governs the protection and handling of confidential information shared during clinical trials. It establishes obligations for all parties involved in the trial regarding the use, disclosure, and protection of sensitive information, including trial data, intellectual property, and patient information. The agreement ensures compliance with UK data protection laws, clinical trial regulations, and research ethics frameworks while protecting the commercial interests of the trial sponsor.

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What is a Clinical Trial Confidentiality Agreement?

Clinical Trial Confidentiality Agreements are essential documents used when conducting medical research involving human subjects in England and Wales. These agreements are required whenever confidential information needs to be shared between parties involved in a clinical trial, including trial protocols, patient data, research methods, and preliminary results. The agreement ensures all parties understand their obligations regarding confidentiality, data protection, and permitted uses of information, while complying with UK regulatory requirements and Good Clinical Practice guidelines. A well-drafted Clinical Trial Confidentiality Agreement is crucial for protecting intellectual property rights and maintaining the integrity of the research process.

What sections should be included in a Clinical Trial Confidentiality Agreement?

1. Parties: Details of the contracting parties including registered addresses

2. Background: Context of the clinical trial and purpose of the agreement

3. Definitions: Key terms used throughout the agreement including 'Confidential Information', 'Clinical Trial', 'Study Data'

4. Confidentiality Obligations: Core obligations regarding handling of confidential information

5. Permitted Uses: Allowed uses of confidential information

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

7. Return of Confidential Information: Obligations upon termination

What sections are optional to include in a Clinical Trial Confidentiality Agreement?

1. Data Protection: Specific data protection obligations - required if personal data is involved

2. Publication Rights: Rights to publish trial results - include if academic institutions involved

3. Third Party Disclosure: Rules for sharing with subcontractors - include if third parties will be involved

What schedules should be included in a Clinical Trial Confidentiality Agreement?

1. Schedule 1 - Trial Protocol Summary: Brief overview of the clinical trial protocol

2. Schedule 2 - Authorized Recipients: List of individuals/roles authorized to access confidential information

3. Schedule 3 - Data Processing Terms: Detailed data protection obligations if personal data involved

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

Jurisdiction

England and Wales

Publisher

Genie AI

Cost

Free to use
Relevant legal definitions
Clauses
Industries

UK GDPR: UK General Data Protection Regulation governing the processing of personal data, particularly relevant for clinical trial data management and participant information

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

PECR: Privacy and Electronic Communications Regulations governing electronic communications and confidentiality in the UK

Clinical Trials Regulations 2004: The Medicines for Human Use (Clinical Trials) Regulations establishing the legal framework for conducting clinical trials in the UK

GCP Guidelines: Good Clinical Practice guidelines setting standards for design, conduct, and reporting of clinical trials

Human Medicines Regulations 2012: Regulations governing the authorization, manufacture, distribution, sale and supply of medicines in the UK

Human Tissue Act 2004: Legislation regulating the storage, use, and disposal of human tissue in research and clinical trials

Mental Capacity Act 2005: Law protecting vulnerable individuals who may lack capacity to make decisions about participating in clinical trials

NHS Research Governance Framework: Framework setting standards for research in the NHS and protecting the rights of research participants

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

Patents Act 1977: Legislation protecting inventions and innovations that may arise from clinical trials

Trade Secrets Regulations 2018: Trade Secrets (Enforcement, etc.) Regulations protecting confidential business information and know-how

Clinical Trials Regulation EU 536/2014: EU regulation still relevant post-Brexit, harmonizing rules for conducting clinical trials

ABPI Guidelines: Association of the British Pharmaceutical Industry guidelines establishing industry standards and best practices

HRA Requirements: Health Research Authority requirements for research ethics and governance in health and social care research

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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