Interim Guidance on Protection of Personal Data & Commercially Confidential Information

Following the previously published public consultation document on Data Protection of Information Uploaded in the CTIS and the Questions and Answers on Data Protection, the EMA has now published an interim guidance. The document is available for CTIS users and provides guidance on the protection of personal data and commercially confidential information (CCI) while using CTIS. According to the agency, "this is meant to assist sponsors and authorities in fulfilling the transparency obligations set out in the Clinical Trials Regulation". In principle, personal data should be provided in CTIS only when required and necessary to facilitate collaboration within the parties.

Content of the Annex

 The Annex of the interim guidance document contains the following four tables:

  • Table I: Data and documents uploaded by the trial sponsor and Marketing Authorisation Applicants/Holders that provide Clinical Study Reports (CSRs)
  • Table II: Data and documents uploaded by the Authorities, including MSC (National Competent Authorities & Ethics Committees) and European Commission
  • Table III: Trial categories and definition of trial phases subject to each category (e.g. pharmaceutical development clinical trials, therapeutic exploratory and confirmatory clinical trials, therapeutic use clinical trials)
  • Table IV: Deferral groups and trial categories permitting deferral including conditions 

For more information please see the Interim guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.0 and the corresponding Annex published on EMA´s Clinical Trials Information System: training and support Website.

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