Europe – Clinical Trials Information System (CTIS) highlights – December 2020

“The Clinical Trials Information System (CTIS) is a corner stone of the Clinical Trials Regulation (EU) No 536/2014. It provides a paperless and integrated system which covers the full life cycle of a clinical trial application, from initial submission to authorisation, conduct, corrective measures, inspection information, and publication of relevant
documents for the general public as well as substantial modifications over time. CTIS will achieve all of this for the sponsor and the Member States through one collaborative, consistent approach and technology. The harmonised submission procedure (single submission) will improve information-sharing between NCAs and Ethics Committees and
will bring time and cost savings to sponsors by removing the need for country-specific submission. An increased transparency of CT information, improved research & development and facilitated access to clinical trials data, as well as enhanced patient safety, will be achieved in Europe with this new way of working. All users of CTIS will benefit from the integration of the different modules of the system in terms of efficiency and increased data quality”…