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Confidential Disclosure Agreement In Clinical Research Template for Philippines

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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 pharmaceutical company and three research sites in Manila for a Phase II clinical trial starting March 2025, with specific provisions for handling patient data and biological samples."

Document background
The Confidential Disclosure Agreement In Clinical Research is essential for any clinical research activities in the Philippines where sensitive medical, technical, or proprietary information needs to be shared between parties. This document is particularly crucial given the stringent requirements of the Philippine Data Privacy Act of 2012 and various clinical research regulations. It is commonly used when initiating clinical trials, collaborative research projects, or when sharing sensitive patient data and research methodologies. The agreement must comply with Philippine FDA regulations, Good Clinical Practice guidelines, and national ethical guidelines for health-related research. It typically covers detailed provisions for data protection, permitted uses, security protocols, and confidentiality obligations, while considering both local and international research standards.
Suggested Sections

1. Parties: Identification of the disclosing and receiving parties, including their legal status and authority to enter into the agreement

2. Background: Context of the clinical research project and purpose of sharing confidential information

3. Definitions: Detailed definitions including 'Confidential Information', 'Clinical Research', 'Study Data', 'Research Materials', and other key terms

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

5. Purpose of Disclosure: Specific permitted uses of the confidential information related to the clinical research

6. Obligations of Confidentiality: Core confidentiality obligations and security measures required

7. Data Privacy Compliance: Specific provisions ensuring compliance with the Philippine Data Privacy Act

8. Standard of Care: Required standards for protecting confidential information

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

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

11. Governing Law and Jurisdiction: Specification of Philippine law and jurisdiction

12. Entire Agreement: Integration clause and relationship to other agreements

Optional Sections

1. Regulatory Compliance: Additional provisions for compliance with specific regulatory requirements, used when dealing with regulated clinical trials

2. Third Party Disclosure: Provisions for sharing with approved third parties, used when third-party contractors or consultants need access

3. Publication Rights: Procedures for publishing research results, used when academic institutions are involved

4. Intellectual Property Rights: Specific IP provisions, used when research may generate new IP

5. Insurance and Indemnification: Additional protection provisions, used in high-risk clinical research

6. International Transfer of Data: Provisions for international data transfers, used when research involves multiple countries

7. Survival Clause: Specific provisions that continue after termination, used in long-term research projects

Suggested Schedules

1. Schedule A - Description of Clinical Research Project: Detailed description of the specific clinical research project

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

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

4. Schedule D - Data Privacy Requirements: Detailed data privacy and protection requirements specific to the project

5. Appendix 1 - Form of Confidentiality Undertaking: Template for confidentiality undertakings by individual staff members

6. Appendix 2 - Data Handling Procedures: Specific procedures for handling, storing, and transferring confidential data

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

Relevant legal definitions








































Clauses




























Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Academic Research

Healthcare Technology

Life Sciences

Medical Education

Healthcare Data Management

Public Health

Relevant Teams

Legal

Clinical Operations

Research & Development

Regulatory Affairs

Data Protection

Clinical Development

Medical Affairs

Compliance

Research Ethics

Quality Assurance

Clinical Documentation

Medical Information

Research Administration

Relevant Roles

Clinical Research Director

Research Principal Investigator

Medical Director

Clinical Trial Manager

Research Coordinator

Data Protection Officer

Legal Counsel

Regulatory Affairs Manager

Clinical Operations Manager

Research Ethics Committee Member

Medical Science Liaison

Clinical Development Manager

Research Compliance Officer

Clinical Research Associate

Healthcare Privacy Officer

Industries








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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