Interim Guidance Document on How to Approach the Protection of Personal Data and Commercially Confidential Information While Using the Clinical Trials Information System (CTIS)

3 May 2023 – the EMA published version 1.0 of the interim guidance on protecting personal data and confidential information while using the CTIS.

This guidance document and accompanying annex help CTIS users navigate through the system functionalities and understand the main principles to be followed to enable protection of personal data and commercially confidential information while using CTIS and publishing clinical trials data and documents.

Interim Guidance Annex