Records of Data Processing Activity (public) Regarding the Processing of Personal Data in the Clinical Trials Information System (CTIS)

28 November 2022 – EMA published updated guidance on CTIS data processing activities.

The purpose of the CTIS data processing activities is based on the requirements set out in the Clinical Trials Regulation (Regulation (EU) No 536/2014), including the areas of clinical trials, annual safety reports Registration of organizations/CTIS users and management of access permissions.

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