Clinical Trial Confidentiality Agreement Template for Philippines

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Key Requirements PROMPT example:

Clinical Trial Confidentiality Agreement

"I need a Clinical Trial Confidentiality Agreement between our pharmaceutical company and three research sites in Manila for a Phase III diabetes drug trial, with specific provisions for handling genetic data and international data transfers to our headquarters in Singapore."

Document background
The Clinical Trial Confidentiality Agreement is essential for protecting sensitive information exchanged during clinical trials in the Philippines. It should be used whenever parties engage in clinical research activities where confidential information will be shared, including trial protocols, patient data, research methodologies, and preliminary results. The agreement ensures compliance with the Philippine Data Privacy Act of 2012, FDA Administrative Order No. 2020-0010, and other relevant healthcare regulations. It addresses specific requirements for data protection in clinical research, including provisions for handling sensitive personal information, maintaining trial integrity, and protecting intellectual property rights. This document is particularly crucial given the increasing number of clinical trials conducted in the Philippines and the stringent regulatory requirements for protecting trial-related information.
Suggested Sections

1. Parties: Identifies the parties entering into the agreement, including the trial sponsor, research institution, and any other relevant parties

2. Background: Sets out the context of the agreement, including the nature of the clinical trial and the purpose of sharing confidential information

3. Definitions: Defines key terms including 'Confidential Information', 'Clinical Trial', 'Study Data', 'Study Materials', and other relevant terms

4. Scope of Confidential Information: Clearly identifies what information is considered confidential under the agreement

5. Confidentiality Obligations: Details the core obligations regarding the protection and non-disclosure of confidential information

6. Permitted Uses: Specifies the authorized uses of confidential information in relation to the clinical trial

7. Data Privacy Compliance: Addresses compliance with Philippine Data Privacy Act requirements and other relevant data protection laws

8. Security Measures: Outlines the required security measures for protecting confidential information

9. Term and Survival: Specifies the duration of the agreement and which obligations survive termination

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

11. Breach and Remedies: Specifies the consequences of breaching the agreement and available remedies

12. General Provisions: Standard contract clauses including governing law, jurisdiction, and entire agreement

Optional Sections

1. Third Party Disclosure: Include when confidential information may need to be shared with third parties such as regulators or subcontractors

2. Publication Rights: Include when parties need to address rights to publish clinical trial results or related research

3. Intellectual Property Rights: Include when the clinical trial may generate new IP or when background IP needs protection

4. Personnel Requirements: Include when specific requirements for personnel handling confidential information need to be detailed

5. International Data Transfers: Include when confidential information may be transferred outside the Philippines

6. Insurance and Indemnification: Include when specific risk allocation related to confidential information handling is required

Suggested Schedules

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

2. Schedule 2 - Specific Categories of Confidential Information: Detailed list of types of confidential information covered by the agreement

3. Schedule 3 - Authorized Personnel: List of authorized personnel who will have access to confidential information

4. Schedule 4 - Security Protocols: Detailed security measures and protocols for handling confidential information

5. Schedule 5 - Data Privacy Requirements: Specific requirements under Philippine data privacy laws and regulations

6. Appendix A - Form of Confidentiality Undertaking: Template confidentiality undertaking for individual staff members

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

Relevant legal definitions
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

Data Protection

Clinical Research

Compliance

Medical Affairs

Research Ethics

Quality Assurance

Clinical Documentation

Site Management

Relevant Roles

Clinical Research Director

Medical Director

Research Coordinator

Principal Investigator

Clinical Trial Manager

Data Protection Officer

Research Ethics Committee Member

Clinical Operations Manager

Legal Counsel

Regulatory Affairs Manager

Study Monitor

Chief Medical Officer

Research and Development Director

Clinical Research Associate

Compliance Officer

Site Manager

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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