Confidential Disclosure Agreement In Clinical Research

Confidential Disclosure Agreement In Clinical Research Template for Malaysia

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Key Requirements PROMPT example:

"I need a Confidential Disclosure Agreement In Clinical Research under Malaysian law for a collaboration between our pharmaceutical company and three research institutions in Kuala Lumpur, specifically covering a new cancer treatment trial starting in March 2025."

Document background

The Confidential Disclosure Agreement In Clinical Research is essential for protecting sensitive information exchanged during clinical research activities in Malaysia. This agreement is typically used when parties need to share confidential information for conducting clinical trials, research studies, or evaluating potential research collaboration opportunities. It ensures compliance with Malaysian legislation, including the Personal Data Protection Act 2010, Medical Act 1971, and Malaysian Good Clinical Practice Guidelines. The agreement covers various types of confidential information including but not limited to patient data, research protocols, trial results, proprietary methodologies, and intellectual property. It is particularly crucial in the Malaysian healthcare sector where protection of patient information and research data is strictly regulated, and where international collaboration in clinical research is common.

Suggested Sections

1. Parties: Identification of the disclosing and receiving parties, including their legal status and registered addresses

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

3. Definitions: Definitions of key terms including 'Confidential Information', 'Clinical Trial Data', 'Research Project', 'Permitted Purpose'

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

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 to regulatory authorities and ethics committees

7. Data Protection Compliance: Specific obligations regarding personal data protection under Malaysian law

8. Security Measures: Required security measures for protecting confidential information

9. Return or Destruction of Information: Obligations regarding the return or destruction of confidential information upon agreement termination

10. Term and Termination: Duration of the agreement and termination provisions

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

12. General Provisions: Standard contract clauses including notices, amendments, and severability

Optional Sections

1. Mutual Disclosure Provisions: Additional provisions for cases where both parties will be disclosing confidential information

2. Intellectual Property Rights: Specific provisions regarding IP rights in research findings and innovations

3. Publication Rights: Terms governing the right to publish research results while maintaining confidentiality

4. Research Ethics Compliance: Additional provisions regarding compliance with research ethics requirements

5. International Transfer of Data: Provisions for cases involving cross-border transfer of research data

6. Regulatory Compliance: Additional provisions for specific regulatory requirements in specialized clinical research

7. Insurance and Liability: Provisions regarding insurance requirements and liability allocation for data breaches

Suggested Schedules

1. Schedule 1 - Description of Research Project: Detailed description of the clinical research project scope

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

3. Schedule 3 - Security Protocols: Detailed security measures and protocols for handling confidential information

4. Schedule 4 - Data Processing Requirements: Specific requirements for processing personal and clinical data

5. Appendix A - Form of Confidentiality Undertaking: Template confidentiality undertaking for employees and contractors

6. Appendix B - Data Breach Protocol: Procedures to be followed in case of data breach

Authors

Alex Denne

Head of Growth (Open Source Law) @ ��Ƶ | 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

Clinical Research

Academic Research

Healthcare Technology

Life Sciences

Medical Education

Public Health

Relevant Teams

Legal

Clinical Operations

Research & Development

Medical Affairs

Regulatory Affairs

Compliance

Data Protection

Clinical Research

Contract Management

Ethics Committee

Research Administration

Relevant Roles

Clinical Research Director

Research & Development Manager

Medical Affairs Manager

Clinical Trial Coordinator

Principal Investigator

Research Ethics Officer

Legal Counsel

Compliance Officer

Data Protection Officer

Clinical Operations Manager

Research Scientist

Medical Director

Regulatory Affairs Manager

Contract Manager

Chief Medical Officer

Research Administrator

Clinical Project Manager

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