Europe – Clinical Trial Regulation : Update

In March 2020, EMA’s Management Board endorsed the audit methodology for CTIS enabling the process for the selection of the supplier for the audit of the system to commence.

EMA, together with product owners, is carrying out a second readiness assessment in the first months of 2020 to identify critical items that must be addressed prior to the audit. This will be followed by a further operational assessment (including of the public portal) to determine the full scope of the auditable version. Specialised users, in collaboration with the product owners, have already assessed the ‘union control’ and ‘inspection’ modules of CTIS.

EMA is closely monitoring performance of the IT supplier to ensure timely delivery of a reliable audit version of CTIS…