December 2022: CTIS Update

European Medicines Agency updated the page Clinical Trials Information System: training and support over the What’s New Section on December 22, 2022, by uploading a new version of the CTIS: Sponsor handbook-

A new version of the CTIS: Sponsor handbook (v3.01) is now available. Below are the recent updates in the new version:

  • Section 4.1: Update of timelines due dates in CTIS
  • Section 7.1.3.2: Update of document upload size
  • Section 5.1 and 5.2.2: Clarifications on dates for the transition period
  • Minor editorial changes