Clinical Trials Information System (CTIS) newsletter Issue 3 published

The Clinical Trials Information System (CTIS) newsletter Issue 3 of June 2021 has now been published.

This issue includes information on the following topics:

  • Key organisation models in CTIS
    • The organisation-centric approach – is used by authority users (EU Member States and EEA countries) and by sponsors,
    • The trial-centric approach – is only available for sponsor users
  • CTIS system functionalities – CTIS allows sponsor users to manage a clinical trial during its life cycle through the following different system functionalities
  • Sponsor views on CTIS and how to prepare for it
  • CTIS training for SMEs & Academia – On 22 February & 4 March 2021 EMA organised a CTIS training for SMEs & Academia. A recording of the webinars is available here (Day 1) and here (Day 2).
  • Initial clinical trial application process in CTIS
  • Training Programme update
  • CTIS User Personas
  • Audit update

Source: EMA website