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Clinical Trial Confidentiality Agreement

Clinical Trial Confidentiality Agreement Template for Malaysia

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Key Requirements PROMPT example:

Clinical Trial Confidentiality Agreement

"I need a Clinical Trial Confidentiality Agreement for a Phase II diabetes drug trial starting March 2025, between our Malaysian pharmaceutical company and the University of Malaya Medical Centre, with specific provisions for handling patient genetic data and potential academic publications."

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Document background
The Clinical Trial Confidentiality Agreement is essential for protecting sensitive information exchanged during clinical trials in Malaysia. It is typically used when initiating new clinical research projects, particularly when multiple parties need to share confidential information such as trial protocols, patient data, research methodologies, and proprietary information. This agreement ensures compliance with Malaysian regulations, including the Personal Data Protection Act 2010, Control of Drugs and Cosmetics Regulations 1984, and Good Clinical Practice Guidelines. The document is crucial for establishing clear confidentiality obligations, data protection measures, and permitted disclosure parameters before any sensitive information is shared between parties involved in the clinical trial process.
Suggested Sections

1. Parties: Identification of the contracting parties, including the trial sponsor, research institution, and any other relevant parties

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

3. Definitions: Detailed 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. Obligations of Confidentiality: Core confidentiality obligations, including handling, storage, and protection of confidential information

6. Permitted Disclosures: Circumstances under which confidential information may be disclosed, including regulatory requirements and consent procedures

7. Data Protection and Security: Specific measures required to protect personal data and trial information in compliance with Malaysian law

8. Term and Survival: Duration of the agreement and obligations that survive termination

9. Return or Destruction of Confidential Information: Procedures for handling confidential information after the agreement ends

10. Governing Law and Jurisdiction: Specification of Malaysian law as governing law and jurisdiction for disputes

Optional Sections

1. Intellectual Property Rights: Section addressing ownership and protection of IP rights, used when the trial involves potential patentable discoveries

2. Publication Rights: Procedures for academic publication of trial results, included when involving academic institutions

3. Third Party Disclosure: Additional provisions for handling disclosure to third party contractors or service providers

4. Insurance and Liability: Additional provisions regarding insurance requirements and liability allocation, used in high-risk trials

5. Regulatory Compliance: Specific provisions addressing compliance with particular regulatory requirements, used when trial involves regulated products

6. Data Transfer: Provisions for international data transfer, used when trial data will be processed across borders

Suggested Schedules

1. Schedule 1 - Description of Clinical Trial: Detailed description of the clinical trial, including protocol number and brief summary

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 Protection Requirements: Specific requirements for compliance with Malaysian Personal Data Protection Act

5. Appendix A - Confidentiality Acknowledgment Form: Form to be signed by individual staff members accessing confidential information

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

Linkedin in social icon imageX social icon image
alex.den.21@genieai.co
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Academic Research

Healthcare Technology

Life Sciences

Relevant Teams

Legal

Clinical Operations

Research and Development

Regulatory Affairs

Compliance

Data Protection

Clinical Research

Medical Affairs

Contract Management

Research Ethics

Relevant Roles

Clinical Research Director

Medical Director

Research Coordinator

Legal Counsel

Compliance Officer

Data Protection Officer

Clinical Trial Manager

Principal Investigator

Research Ethics Committee Member

Regulatory Affairs Manager

Contract Manager

Medical Science Liaison

Clinical Operations Manager

Research and Development Director

Chief Medical Officer

Industries
Personal Data Protection Act 2010: Malaysia's main data protection legislation that governs the collection, processing, and handling of personal data, including sensitive medical information in clinical trials
Control of Drugs and Cosmetics Regulations 1984: Regulations governing clinical trials, including requirements for conducting medical research and handling trial-related information
Contracts Act 1950: Malaysian law governing the formation and enforcement of contracts, ensuring the confidentiality agreement is legally binding
Medical Act 1971: Regulates medical practice and research, including provisions affecting clinical trials and medical data handling
Guidelines for Good Clinical Practice (GCP) Malaysia: National guidelines that establish standards for conducting clinical trials, including requirements for data confidentiality and subject privacy
Patents Act 1983: Protects intellectual property rights related to clinical trial innovations and discoveries
Official Secrets Act 1972: May be relevant if the clinical trial involves government institutions or public healthcare facilities
Medical Device Act 2012: Relevant if the clinical trial involves medical devices, including provisions for confidentiality of device-related information
Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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