The Confidential Disclosure Agreement In Clinical Research is essential for organizations conducting or participating in clinical research activities in Denmark. It is specifically designed to protect confidential information exchanged during clinical research projects, including sensitive patient data, research protocols, study results, and proprietary methodologies. This agreement type is crucial when research organizations, pharmaceutical companies, or healthcare institutions need to share sensitive information while ensuring compliance with Danish law, including the Danish Data Protection Act and Medicines Act, as well as EU regulations such as GDPR and the Clinical Trials Regulation. The document is particularly relevant for multi-party research collaborations where protection of intellectual property, patient data, and research methodologies is paramount. It includes specific provisions addressing the unique aspects of clinical research data protection within the Danish legal framework.
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Key Requirements PROMPT example:
Confidential Disclosure Agreement In Clinical Research
I need a Confidential Disclosure Agreement In Clinical Research under Danish law for a multi-site Phase III clinical trial collaboration between our pharmaceutical company and three university hospitals, with strict data protection provisions for sensitive patient data and research protocols.
1. Parties: Identification of the disclosing and receiving parties, including full legal names, registration numbers, and addresses
2. Background: Context of the clinical research project and purpose of information sharing
3. Definitions: Define key terms including 'Confidential Information', 'Clinical Research Project', 'Study Data', and 'Trade Secrets'
4. Scope of Confidential Information: Detailed description of what constitutes confidential information in the clinical research context
5. Permitted Use: Specific purposes for which the confidential information may be used, limited to the clinical research project
6. Confidentiality Obligations: Core obligations regarding protection, non-disclosure, and handling of confidential information
7. Data Protection and GDPR Compliance: Specific provisions relating to handling of personal data and compliance with GDPR and Danish data protection laws
8. Security Measures: Required technical and organizational measures for protecting confidential information
9. Return or Destruction: Obligations regarding return or destruction of confidential information upon termination
10. Term and Termination: Duration of the agreement and termination provisions
11. Survival: Provisions that continue after termination, particularly confidentiality obligations
12. Governing Law and Jurisdiction: Specification of Danish law and jurisdiction
1. Third Party Disclosure: Required when confidential information may need to be shared with approved third parties such as contract research organizations or regulatory authorities
2. Publication Rights: Include when parties need to address rights to publish research results while protecting confidential information
3. Intellectual Property Rights: Include when confidential information may involve patentable inventions or other IP rights
4. Clinical Trial Regulations Compliance: Include when the CDA specifically relates to a clinical trial subject to EU Clinical Trials Regulation
5. Breach Notification: Detailed procedures for handling and reporting confidentiality breaches, particularly relevant for high-sensitivity data
6. Insurance and Liability: Include when parties want to specify liability limitations and insurance requirements
7. Language: Include when agreement needs to be in both English and Danish with specification of prevailing version
1. Schedule 1 - Description of Clinical Research Project: Detailed description of the research project and context for information sharing
2. Schedule 2 - Categories of Confidential Information: Detailed listing of types of confidential information to be shared
3. Schedule 3 - Authorized Recipients: List of individuals or roles authorized to receive confidential information
4. Schedule 4 - Security Protocols: Specific technical and organizational security measures required
5. Schedule 5 - Data Processing Terms: Detailed GDPR-compliant data processing terms if personal data is involved
Authors
Relevant legal definitions
Agreement
Affiliated Company
Authorized Recipients
Background IP
Clinical Research Project
Clinical Trial
Confidential Information
Disclosing Party
Effective Date
Force Majeure
GDPR
Information Security Breach
Intellectual Property Rights
Personal Data
Principal Investigator
Purpose
Receiving Party
Representatives
Research Data
Research Protocol
Research Results
Study Data
Study Site
Term
Third Party
Trade Secrets
Technical Information
Trial Subject
Data Controller
Data Processor
Proprietary Information
Research Institution
Sponsor
Business Day
Regulatory Authority
Research Ethics Committee
Clinical Trial Regulations
Permitted Purpose
Confidentiality Period
Research Documentation
Material Transfer
Affiliated Company
Authorized Recipients
Background IP
Clinical Research Project
Clinical Trial
Confidential Information
Disclosing Party
Effective Date
Force Majeure
GDPR
Information Security Breach
Intellectual Property Rights
Personal Data
Principal Investigator
Purpose
Receiving Party
Representatives
Research Data
Research Protocol
Research Results
Study Data
Study Site
Term
Third Party
Trade Secrets
Technical Information
Trial Subject
Data Controller
Data Processor
Proprietary Information
Research Institution
Sponsor
Business Day
Regulatory Authority
Research Ethics Committee
Clinical Trial Regulations
Permitted Purpose
Confidentiality Period
Research Documentation
Material Transfer
Clauses
Confidentiality
Data Protection
Use Restrictions
Information Security
Return of Information
Term and Termination
Survival
Governing Law
Dispute Resolution
Force Majeure
Assignment
Regulatory Compliance
Clinical Trial Compliance
Third Party Rights
Disclosure to Authorities
Publication Rights
Research Ethics
Breach Notification
Liability
Indemnification
Intellectual Property
Notices
Entire Agreement
Severability
Amendments
Waiver
Counterparts
Research Integrity
Data Handling
Security Measures
Data Protection
Use Restrictions
Information Security
Return of Information
Term and Termination
Survival
Governing Law
Dispute Resolution
Force Majeure
Assignment
Regulatory Compliance
Clinical Trial Compliance
Third Party Rights
Disclosure to Authorities
Publication Rights
Research Ethics
Breach Notification
Liability
Indemnification
Intellectual Property
Notices
Entire Agreement
Severability
Amendments
Waiver
Counterparts
Research Integrity
Data Handling
Security Measures
Relevant Industries
Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Clinical Research
Life Sciences
Academic Research
Healthcare Technology
Laboratory Services
Medical Diagnostics
Relevant Teams
Legal
Clinical Operations
Research & Development
Regulatory Affairs
Medical Affairs
Compliance
Data Protection
Business Development
Scientific Affairs
Clinical Research
Ethics Committee
Contracts Administration
Intellectual Property
Information Security
Relevant Roles
Clinical Research Director
Legal Counsel
Research Project Manager
Clinical Trial Manager
Data Protection Officer
Chief Medical Officer
Research Scientist
Clinical Operations Manager
Regulatory Affairs Manager
Business Development Director
Research & Development Director
Chief Scientific Officer
Clinical Study Coordinator
Medical Affairs Director
Compliance Officer
Research Ethics Officer
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