European Medicines Agency (EMA) updated the page Clinical Trials Information System: training and support, on October 15, 2021, by adding reference material for clinical trial sponsors:
EMA made available reference materials that assist sponsors in using CTIS. It guides sponsors on how to create a user account, roles, responsibilities, user roles within CTIS, data fields to fill in CTIS while submitting and managing a clinical trial application.
Recently added reference material includes Principles for Sponsor organisation modelling for CTIS (v.1) and CTIS User Personas (updated).
For more information, please click here.