Clinical Trial Confidentiality Agreement

Clinical Trial Confidentiality Agreement Template for Singapore

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Key Requirements PROMPT example:

"I need a Clinical Trial Confidentiality Agreement under Singapore law for a multi-site cancer drug trial starting in March 2025, with specific provisions for sharing data with academic institutions and publishing results in medical journals."

Document background

The Clinical Trial Confidentiality Agreement is essential when conducting medical research in Singapore, where strict regulatory compliance is required. This agreement is typically used before sharing sensitive information about clinical trials, including trial protocols, patient data, research methodologies, and proprietary information. It ensures compliance with Singapore's regulatory framework, including the Personal Data Protection Act, Healthcare Services Act, and Human Biomedical Research Act. The agreement protects both the sponsor's intellectual property and trial participants' privacy while facilitating necessary information sharing between research partners.

Suggested Sections

1. Parties: Identification of the contracting parties, including sponsor, research institution, and investigators

2. Background: Context of the clinical trial and purpose of the confidentiality agreement

3. Definitions: Key terms including 'Confidential Information', 'Clinical Trial', 'Study Data', 'Trial Participants'

4. Scope of Confidential Information: Detailed description of what constitutes confidential information in the context of the trial

5. Obligations of Confidentiality: Core confidentiality obligations and permitted uses of information

6. Term and Survival: Duration of the agreement and surviving obligations

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

8. Governing Law: Specification of Singapore law and jurisdiction

Optional Sections

1. Publication Rights: Terms for academic publication of trial results when involving academic institutions

2. Third Party Disclosure: Rules for sharing information with authorized third parties when multiple research sites or contractors are involved

3. Intellectual Property Rights: Protection of IP arising from the trial when novel discoveries may arise

4. Data Protection Compliance: Specific PDPA compliance measures when processing personal data beyond standard trial data

Suggested Schedules

1. Schedule 1: Description of Clinical Trial: Details of the trial protocol and scope

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

3. Schedule 3: Security Measures: Specific security protocols for handling confidential information

4. Schedule 4: Data Handling Procedures: Detailed procedures for managing trial data and confidential information

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok��˰� | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co

Relevant legal definitions

Clauses

Relevant Industries

Pharmaceuticals
Healthcare
Biotechnology
Medical Devices
Academic Research

Relevant Teams

Legal
Research & Development
Clinical Operations
Regulatory Affairs
Data Management
Medical Affairs

Relevant Roles

Clinical Research Director
Principal Investigator
Legal Counsel
Research Coordinator
Data Protection Officer
Medical Affairs Manager

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Let's create your Clinical Trial Confidentiality Agreement

Authors

Alex Denne

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