Clinical Trials Information System (CTIS) Highlights – June 2021

On 23 June 2021 the EMA published Issue 3 of the CTIS newsletter.

Issue 3 of this newsletter covers the organisation-centric and trial-centric approach and process of assigning roles in CTIS, and also includes the following:

  • Key Organisation models
  • High-level Administrator and clinical trial administrator roles
  • CTIS system functionalities
  • Sponsor views
  • Initial clinical trial application process
  • Training Programme update
  • CTIS User Personas
  • Audit update
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