This Q&A document has been created to provide preliminary guidance to CTIS users on how to protect personal data and commercially confidential information (CCI) in CTIS, the EU database established in accordance with the requirements of Regulation (EU) No 536/2014 (CTR).
The Q&A document has been produced to address a number of questions related to the transparency aspects of CTIS which were communicated by sponsors in response to the ACT EU survey on the CTR implementation under ACT EU Priority action 2 (Successful implementation of the CTR). It is foreseen that the Q&A may be updated on a regular basis as soon as new information becomes available.
The Q&A intends to provide more clarity on main aspects that have been discussed with the Clinical Trials Coordination Group (CTCG) and it should be read in conjunction with the Guidance document on how to approach protection of personal data and commercial confidential information while using
Clinical Trials Information System (CTIS).