This document is based on questions frequently raised to EMA by sponsors during CTIS events such as Walk-in Clinics, Bitesize Talks, and through the EMA CTIS Service Desk. It serves as complementary document to the Sponsor Handbook, which is the main operational guidance for sponsors when using CTIS.
Note that the following two documents may also be consulted when looking for answers to frequent questions on CTIS and the Clinical Trial Regulation (EU) No 536/2014, hereinafter (‘CTR’):
• the Clinical Trial Regulation Questions and Answers (CTR Q&A)
• the FAQ document listed among the ‘Key document list’ of the Clinical Trials Coordination Group
(CTCG) page