Clinical Trial Confidentiality Agreement Template for Ireland

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Key Requirements PROMPT example:

Clinical Trial Confidentiality Agreement

"I need a Clinical Trial Confidentiality Agreement for a Phase II diabetes drug trial starting in March 2025, which will involve three research sites in Ireland and requires specific provisions for handling biomarker data and genetic information."

What is a Clinical Trial Confidentiality Agreement?

A Clinical Trial Confidentiality Agreement is a crucial document required before initiating any clinical trial activities in Ireland. This agreement is essential when confidential information needs to be shared between trial sponsors, research institutions, and investigators during the planning and conduct of clinical trials. It ensures protection of sensitive information including trial protocols, investigational product details, patient data, and research methodologies. The agreement must comply with Irish law, including the Health Research Regulations 2018, as well as EU regulations such as the Clinical Trials Regulation and GDPR. It is typically executed during the trial feasibility and site selection phase, before any detailed trial information is shared with potential investigators or sites. The document serves as a foundation for the broader clinical trial agreement that may follow.

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

1. Parties: Identification of the disclosing party (typically sponsor/CRO) and receiving party (typically investigator/institution), including full legal names and addresses

2. Background: Context of the clinical trial, purpose of sharing confidential information, and general scope of the proposed trial

3. Definitions: Key terms including 'Confidential Information', 'Clinical Trial', 'Study Drug', 'Protocol', and other relevant terms specific to clinical research

4. Scope of Confidential Information: Detailed description of what constitutes confidential information, including trial protocols, patient data, research methods, and study drug information

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

6. Permitted Uses and Disclosures: Authorized uses of confidential information, including trial conduct and regulatory compliance

7. Data Protection and GDPR Compliance: Specific provisions relating to handling of personal data and compliance with GDPR and Irish data protection laws

8. Term and Survival: Duration of confidentiality obligations and which obligations survive termination

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

10. Breach and Remedies: Consequences of confidentiality breaches and available remedies

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

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

1. Publication Rights: Used when academic institutions are involved and need rights to publish research results

2. Third Party Disclosure: Include when information needs to be shared with other trial sites or external vendors

3. Intellectual Property Rights: Needed when trial involves potential IP generation or use of existing IP

4. Insurance and Indemnification: Include for high-risk trials or when required by institutional policies

5. Security Protocols: Add when handling particularly sensitive data or when required by specific regulatory requirements

6. International Data Transfers: Include when trial involves data transfers outside the EEA

7. Regulatory Inspections: Add when trial is likely to be subject to regulatory authority inspections

8. Sub-investigator Obligations: Include when multiple investigators or research staff will have access to confidential information

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

1. Schedule 1 - Description of Clinical Trial: Detailed description of the trial including protocol number and study drug details

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

3. Schedule 3 - Security Measures: Specific security protocols and measures for protecting confidential information

4. Appendix A - Form of Confidentiality Agreement for Staff: Template confidentiality agreement for research staff and sub-investigators

5. Appendix B - Data Processing Requirements: Detailed GDPR and data protection compliance requirements

6. Appendix C - Return/Destruction Certificate: Template certificate confirming return or destruction of 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

Pharmaceuticals

Biotechnology

Healthcare

Medical Devices

Clinical Research

Life Sciences

Academic Research

Healthcare Technology

Contract Research

Medical Testing

Drug Development

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research & Development

Clinical Development

Data Protection

Compliance

Quality Assurance

Medical Affairs

Clinical Research

Study Management

Site Operations

Research Administration

Ethics Committee

Relevant Roles

Clinical Research Director

Principal Investigator

Clinical Trial Manager

Research Coordinator

Legal Counsel

Regulatory Affairs Manager

Data Protection Officer

Clinical Operations Manager

Medical Director

Research Administrator

Compliance Officer

Clinical Development Manager

Site Manager

Research Ethics Officer

Clinical Research Associate

Quality Assurance Manager

Industries
EU Clinical Trials Regulation (EU) No 536/2014: The primary EU regulation governing clinical trials, which has direct effect in Ireland. It sets out requirements for conducting clinical trials, including confidentiality obligations regarding trial data.
S.I. No. 99/2004 - European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004: Irish regulations implementing EU clinical trials directives, providing national framework for clinical trials conduct and associated confidentiality requirements.
General Data Protection Regulation (GDPR) - Regulation (EU) 2016/679: Governs the processing of personal data, including sensitive health data in clinical trials, with specific requirements for confidentiality and data protection.
Data Protection Act 2018: Irish legislation implementing GDPR, providing additional national requirements for processing personal data in research contexts.
Health Research Regulations 2018 (S.I. No. 314/2018): Specific Irish regulations governing health research, including requirements for safeguarding confidential health information in research contexts.
Irish Contract Law: Common law principles governing formation and enforcement of contracts in Ireland, essential for the basic contractual aspects of the confidentiality agreement.
EU Trade Secrets Directive (2016/943): Provides framework for protection of undisclosed know-how and business information, relevant for proprietary information in clinical trials.
European Communities (Protection of Workers) (Exposure to Biological Agents) Regulations 1994: Relevant for clinical trial staff confidentiality obligations regarding biological agents and safety protocols.
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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