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EMA - Public Consultation on the Approach of Protection of Personal data

13th April 2022

 The European Medicines Agency has published for public consultation a draft guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial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).

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
  • The protection of personal data as part of the clinical trial information submitted to CTIS
  • The protection of commercially confidential information (CCI) as part of the clinical trial information submitted to CTIS
  • The protection of personal data and CCI in inspection reports

Comments should be provided using this  template and sent to ct.communication@ema.europa.eu by 8 September 2022: https://www.ema.europa.eu/en/documents/template-form/form-submission-comments-scientific-guidelines_en.doc 

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