Confidential Disclosure Agreement In Clinical Research Template for Singapore

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Key Requirements PROMPT example:

Confidential Disclosure Agreement In Clinical Research

"I need a Confidential Disclosure Agreement In Clinical Research between our research institution and a pharmaceutical company for a Phase II clinical trial starting in March 2025, with specific provisions for handling patient data across multiple hospital sites in Singapore."

Document background

The Confidential Disclosure Agreement In Clinical Research is essential when parties need to share sensitive information during clinical trials or research studies in Singapore. It is particularly relevant when handling patient data, research methodologies, or proprietary information in compliance with Singapore's regulatory framework. This agreement ensures that confidential information is protected while facilitating necessary collaboration between research institutions, pharmaceutical companies, and healthcare providers. It addresses specific requirements under Singapore law, including PDPA compliance and clinical research regulations.

Suggested Sections

1. Parties: Identification of all parties involved in the agreement, including full legal names and addresses

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

3. Definitions: Detailed definitions of key terms, especially 'Confidential Information', 'Clinical Trial', and 'Study Data'

4. Scope of Confidential Information: Detailed description of what constitutes confidential information under the agreement

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

6. Term and Termination: Duration of the agreement and conditions for termination

7. Return or Destruction of Confidential Information: Procedures for handling confidential information after agreement termination

Optional Sections

1. Third Party Disclosure: Terms for sharing information with authorized third parties when third-party contractors or consultants are involved in the research

2. Cross-Border Data Transfer: Provisions for international data transfer when research involves multiple jurisdictions

3. Publication Rights: Terms regarding publication of research results when academic institutions are involved

4. Specific Data Protection Measures: Technical and organizational measures for data protection when handling sensitive personal or medical data

Suggested Schedules

1. Schedule 1: Description of Clinical Trial: Detailed description of the clinical trial or research project

2. Schedule 2: Authorized Representatives: List of authorized personnel who may access confidential information

3. Schedule 3: Data Protection Protocols: Specific procedures for handling and protecting confidential information

4. Schedule 4: Required Notifications: List of circumstances requiring mandatory notification between parties

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 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

Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Academic Research

Relevant Teams

Clinical Research
Legal
Regulatory Affairs
Data Management
Medical Affairs
Compliance

Relevant Roles

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

Industries

PDPA 2012: Personal Data Protection Act - Primary legislation governing the collection, use, disclosure and care of personal data in Singapore

Medicines Act: Chapter 176 - Regulates the manufacture, import, supply, presentation and advertisement of medicines and medical devices

Health Products Act: Legislation controlling health products, including their manufacture, import, supply, and clinical trials

Human Biomedical Research Act 2015: Regulates the conduct of human biomedical research and handling of human tissues

Medicines (Clinical Trials) Regulations: Specific regulations governing the conduct of clinical trials for medicines in Singapore

Health Products (Clinical Trials) Regulations: Regulatory framework for clinical trials involving health products

Singapore Guideline for Good Clinical Practice: Local guidelines ensuring ethical and scientific quality standards in clinical trials

PDPA Data Protection Provisions: Specific provisions regarding data protection obligations and cross-border data transfer requirements

NHG DSRB Guidelines: National Healthcare Group Domain Specific Review Board guidelines for clinical research

SingHealth CIRB Requirements: SingHealth Centralised Institutional Review Board requirements for clinical research

ICH-GCP: International Council for Harmonisation - Good Clinical Practice standards for clinical trials

CIOMS Guidelines: Council for International Organizations of Medical Sciences guidelines for biomedical research

Singapore Contract Law: General contract law principles governing formation and enforcement of agreements in Singapore

Singapore Evidence Act: Laws governing admissibility of evidence, including electronic records and documents

Electronic Transactions Act: Legislation governing electronic communications and transactions

Patents Act: Protection of inventions and innovations in Singapore

Trade Secrets Law: Protection of confidential business information and trade secrets under Singapore common law

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Authors

Alex Denne

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