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Clinical Trial Confidentiality Agreement
"I need a Clinical Trial Confidentiality Agreement between our pharmaceutical company and three research sites in Manila for a Phase III diabetes drug trial, with specific provisions for handling genetic data and international data transfers to our headquarters in Singapore."
1. Parties: Identifies the parties entering into the agreement, including the trial sponsor, research institution, and any other relevant parties
2. Background: Sets out the context of the agreement, including the nature of the clinical trial and the purpose of sharing confidential information
3. Definitions: Defines key terms including 'Confidential Information', 'Clinical Trial', 'Study Data', 'Study Materials', and other relevant terms
4. Scope of Confidential Information: Clearly identifies what information is considered confidential under the agreement
5. Confidentiality Obligations: Details the core obligations regarding the protection and non-disclosure of confidential information
6. Permitted Uses: Specifies the authorized uses of confidential information in relation to the clinical trial
7. Data Privacy Compliance: Addresses compliance with Philippine Data Privacy Act requirements and other relevant data protection laws
8. Security Measures: Outlines the required security measures for protecting confidential information
9. Term and Survival: Specifies the duration of the agreement and which obligations survive termination
10. Return or Destruction of Confidential Information: Procedures for handling confidential information after the agreement ends
11. Breach and Remedies: Specifies the consequences of breaching the agreement and available remedies
12. General Provisions: Standard contract clauses including governing law, jurisdiction, and entire agreement
1. Third Party Disclosure: Include when confidential information may need to be shared with third parties such as regulators or subcontractors
2. Publication Rights: Include when parties need to address rights to publish clinical trial results or related research
3. Intellectual Property Rights: Include when the clinical trial may generate new IP or when background IP needs protection
4. Personnel Requirements: Include when specific requirements for personnel handling confidential information need to be detailed
5. International Data Transfers: Include when confidential information may be transferred outside the Philippines
6. Insurance and Indemnification: Include when specific risk allocation related to confidential information handling is required
1. Schedule 1 - Description of Clinical Trial: Detailed description of the clinical trial, including protocol number and study title
2. Schedule 2 - Specific Categories of Confidential Information: Detailed list of types of confidential information covered by the agreement
3. Schedule 3 - Authorized Personnel: List of authorized personnel who will have access to confidential information
4. Schedule 4 - Security Protocols: Detailed security measures and protocols for handling confidential information
5. Schedule 5 - Data Privacy Requirements: Specific requirements under Philippine data privacy laws and regulations
6. Appendix A - Form of Confidentiality Undertaking: Template confidentiality undertaking for individual staff members
Authors
Agreement
Authorized Personnel
Background Intellectual Property
Clinical Trial
Clinical Trial Protocol
Confidential Information
Data Subject
Disclosing Party
Effective Date
Force Majeure
Good Clinical Practice
Intellectual Property Rights
Investigational Product
Investigator
Study Materials
Patient Data
Personal Information
Principal Investigator
Receiving Party
Representatives
Research Institution
Research Staff
Sensitive Personal Information
Site
Sponsor
Study
Study Data
Study Documentation
Study Results
Study Subject
Term
Third Party
Trial Participant
Confidentiality
Data Protection
Permitted Use
Information Security
Term and Termination
Return or Destruction of Information
Non-Disclosure
Publication Rights
Intellectual Property
Breach Notification
Remedies
Indemnification
Force Majeure
Assignment
Governing Law
Dispute Resolution
Notices
Third Party Rights
Regulatory Compliance
Audit Rights
Personnel Obligations
Severability
Entire Agreement
Amendment
Survival
Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Clinical Research
Academic Research
Healthcare Technology
Life Sciences
Legal
Clinical Operations
Research and Development
Regulatory Affairs
Data Protection
Clinical Research
Compliance
Medical Affairs
Research Ethics
Quality Assurance
Clinical Documentation
Site Management
Clinical Research Director
Medical Director
Research Coordinator
Principal Investigator
Clinical Trial Manager
Data Protection Officer
Research Ethics Committee Member
Clinical Operations Manager
Legal Counsel
Regulatory Affairs Manager
Study Monitor
Chief Medical Officer
Research and Development Director
Clinical Research Associate
Compliance Officer
Site Manager
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