January 2023: Q&A on the Protection of Commercially Confidential Information and Personal Data in CTIS

On January 31, 2023, European Medicines Agency updated about the page Clinical Trials Information System: training and support by adding Questions and answers on the protection of commercially confidential information and personal data while using CTIS.

A Q&A document is uploaded to answer questions related to protection of CCI and personal data in CTIS and the transparency aspects of CTIS which were communicated by the sponsors as a response to the ACT EU survey. The principles described in this Q&A document will also be included in the final version of the Guidance document on how to approach the protection of personal data (PD) and CCI in documents uploaded and published in the CTIS (EMA/212507/2021).