Draft Guidance Document on How to Approach the Protection of Personal Data and Commercially Confidential Information in Documents Uploaded and Published in the Clinical Trial Information System (CTIS)

On 8 April 2022 the EMA published draft guidance on protection of personal data and commercially confidential information in CTIS.

This guidance document focuses on the following areas:

  • Description of the CTIS structure and components including a description of the functionalities and publication rules for clinical trials information submitted to the CTIS (chapter 2)
  • The protection of personal data as part of the clinical trial information submitted to CTIS (chapter 3)
  • The protection of commercially confidential information (CCI) as part of the clinical trial information submitted to CTIS (chapter 4)
  • The protection of personal data and CCI in inspection reports (chapter 5)
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