27-29 February 2024
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.
The Annex of the interim guidance document contains the following four tables:
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.