Create a bespoke document in minutes, Â or upload and review your own.
Get your first 2 documents free
Your data doesn't train Genie's AI
You keep IP ownership of your information
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."
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
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
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
Pharmaceuticals
Biotechnology
Healthcare
Medical Devices
Clinical Research
Life Sciences
Academic Research
Healthcare Technology
Contract Research
Medical Testing
Drug Development
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
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
Find the exact document you need
Clinical Trial Agreement
An Irish law-governed agreement establishing terms and conditions for conducting clinical trials in Ireland, ensuring compliance with EU and Irish clinical trial regulations.
Data Transfer Agreement Clinical Trial
An Irish law-governed agreement for the secure and compliant transfer of clinical trial data between parties, adhering to GDPR and Clinical Trials Regulation requirements.
Accelerated Clinical Trial Agreement
An Irish law-governed agreement for conducting expedited clinical trials, establishing accelerated research protocols while maintaining regulatory compliance.
Clinical Trial Confidentiality Agreement
An Irish law-governed agreement protecting confidential information in clinical trials, ensuring compliance with Irish and EU regulations.
Download our whitepaper on the future of AI in Legal
³Ò±ð²Ô¾±±ð’s Security Promise
Genie is the safest place to draft. Here’s how we prioritise your privacy and security.
Your documents are private:
We do not train on your data; ³Ò±ð²Ô¾±±ð’s AI improves independently
All data stored on Genie is private to your organisation
Your documents are protected:
Your documents are protected by ultra-secure 256-bit encryption
Our bank-grade security infrastructure undergoes regular external audits
We are ISO27001 certified, so your data is secure
Organizational security
You retain IP ownership of your documents
You have full control over your data and who gets to see it
Innovation in privacy:
Genie partnered with the Computational Privacy Department at Imperial College London
Together, we ran a £1 million research project on privacy and anonymity in legal contracts
Want to know more?
Visit our for more details and real-time security updates.
Read our Privacy Policy.