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Clinical Trial Confidentiality Agreement
"I need a Clinical Trial Confidentiality Agreement under Belgian law for a Phase II oncology trial starting March 2025, involving our pharmaceutical company as sponsor, two Belgian university hospitals, and a contract research organization, with specific provisions for handling genetic data."
1. Parties: Identification of all parties to the agreement, including sponsor, research institution, and principal investigator
2. Background: Context of the clinical trial and purpose of sharing confidential information
3. Definitions: Definitions of key terms including Confidential Information, Clinical Trial, Study Data, and other relevant terms
4. Scope of Confidential Information: Detailed description of what constitutes confidential information in the context of the clinical trial
5. Confidentiality Obligations: Core obligations regarding the protection and non-disclosure of confidential information
6. Permitted Uses: Authorized uses of confidential information for the clinical trial
7. Data Protection and GDPR Compliance: Specific provisions relating to personal data protection under GDPR and Belgian law
8. Security Measures: Required security measures for protecting confidential information
9. Return or Destruction of Confidential Information: Procedures for handling confidential information after trial completion or termination
10. Term and Survival: Duration of the agreement and surviving obligations
11. Governing Law and Jurisdiction: Specification of Belgian law as governing law and jurisdiction for disputes
1. Publication Rights: Include when parties need to specify rights to publish trial results while protecting confidential information
2. Third Party Disclosure: Include when there's a need to allow disclosure to specific third parties like regulatory authorities or ethics committees
3. Separate PI Undertaking: Include when the Principal Investigator needs to sign a separate confidentiality undertaking
4. Intellectual Property Rights: Include when confidential information includes IP that needs specific protection
5. Insurance and Liability: Include when specific liability provisions for information breaches are required
6. Subcontractors: Include when either party may need to share information with subcontractors
1. Schedule 1 - Description of Clinical Trial: Detailed description of the clinical trial including protocol number and title
2. Schedule 2 - Authorized Personnel: List of authorized personnel who will have access to confidential information
3. Schedule 3 - Security Protocols: Detailed security measures and protocols for handling confidential information
4. Schedule 4 - Data Processing Agreement: GDPR-compliant data processing terms if personal data is involved
5. Appendix A - Form of Confidentiality Undertaking: Template for additional parties who need to sign confidentiality undertakings
Authors
Affiliates
Background Information
Clinical Trial
Confidential Information
Data Protection Laws
Disclosing Party
Effective Date
Ethics Committee
Good Clinical Practice
Intellectual Property Rights
Investigation Site
Investigator
Personal Data
Principal Investigator
Protocol
Receiving Party
Representatives
Research Institution
Sponsor
Study
Study Data
Study Documents
Study Personnel
Study Product
Study Results
Subject
Technical Information
Term
Third Party
Trial Documentation
Unauthorized Disclosure
Permitted Purpose
Processing
Regulatory Authority
Research Staff
Security Breach
Study Completion
Trade Secrets
Trial Subject
Confidentiality Period
Data Controller
Data Processor
Disclosing Entity
Force Majeure
Licensed Uses
Research Data
Sensitive Personal Data
Sub-processor
Data Protection
Information Security
Term and Termination
Permitted Use
Return of Information
Regulatory Compliance
Breach Notification
Enforcement
Exceptions
Third Party Disclosure
Publication Rights
Intellectual Property
Dispute Resolution
Governing Law
Force Majeure
Assignment
Severability
Entire Agreement
Notices
Amendments
Survival
Liability
Indemnification
Personnel Obligations
Security Measures
Data Processing
Trial Compliance
Document Retention
Access Rights
Pharmaceuticals
Biotechnology
Healthcare
Medical Devices
Clinical Research
Life Sciences
Academic Research
Healthcare Technology
Contract Research
Legal
Clinical Operations
Regulatory Affairs
Research and Development
Clinical Development
Data Protection
Compliance
Medical Affairs
Clinical Research
Ethics Committee
Clinical Research Director
Principal Investigator
Clinical Trial Manager
Research Coordinator
Medical Director
Data Protection Officer
Legal Counsel
Regulatory Affairs Manager
Clinical Operations Manager
Research Ethics Committee Member
Clinical Research Associate
Study Site Manager
Compliance Officer
Clinical Development Director
Find the exact document you need
Clinical Agreement
A Belgian law-governed agreement establishing terms for clinical services and healthcare activities, ensuring compliance with local healthcare regulations and EU standards.
Clinical Site Agreement
Belgian-law governed agreement between sponsors, medical institutions, and investigators for conducting clinical trials, complying with EU and Belgian regulations.
Clinical Trial Confidentiality Agreement
Belgian law-governed confidentiality agreement for clinical trials, ensuring protection of sensitive trial information while complying with EU and Belgian regulations.
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