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The Confidentiality Agreement In Clinical Trials is essential for any clinical research conducted in South Africa, where protection of sensitive medical data and personal information is governed by strict regulations including POPIA and the National Health Act. This agreement is typically used when initiating new clinical trials, establishing research collaborations, or engaging third-party service providers in clinical research. It covers various aspects of confidentiality including trial protocols, patient data, research methods, results, and intellectual property. The document ensures all parties understand their obligations regarding data protection, permitted uses of confidential information, and compliance with South African legal requirements for handling sensitive medical and personal information.

1. Parties: Identification of all parties to the agreement, including sponsor, research institution, principal investigator, and any other key parties

2. Background: Context of the clinical trial, purpose of the agreement, and general framework of the confidentiality obligations

3. Definitions: Detailed definitions including Confidential Information, Clinical Trial, Study Data, Personal Information, Trial Subjects, Study Protocol, etc.

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 medical emergencies

7. Data Protection and Privacy: Specific provisions relating to POPIA compliance and protection of trial subject personal information

8. Security Measures: Required technical and organizational measures for protecting confidential information

9. Term and Survival: Duration of confidentiality obligations and which obligations survive termination

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

11. Breach and Remedies: Consequences of breach and available remedies

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