November 2022: CTIS Training Update

European Medicines Agency (EMA) updated the page Clinical Trials Information System: training and support on November 30, 2022, by adding a new version of the CTIS – Sponsor handbook (v3.0).

The below sections were newly added in version 3.0 of the CTIS – Sponsor handbook:

  1. Section 3.5: Marketing Authorization Holder (MAH) group of users – This section gives a brief idea about the MAH Administrator role and the steps for registration as the MAH Administrator. A link to Module 13 was added for further details.
  2. Section 4: How to get a clinical trial application started in CTIS – This section gives details about drafting a clinical trial application (CTA) dossier, guidance on the navigation of the evaluation tab in CTIS, and information on the assessment activities once the CTA has been submitted.
  3. Section 5.3: How to create a transitional trial in CTIS – This section gives details about creating a transitional trial in CTIS. Links to Training Module 23 are provided for further details.
  4. Section 5.4: How to manage trials transitioned to the Clinical Trial Regulation (CTR) in CTIS – This section gives brief guidance on managing trials once the trial has a recorded authorization in CTIS.

Various sections like Overview of CTA process in CTIS – from submission to decision and reporting (section 1.2), CTIS go-live date (section 1.3), Organisation and Sponsor Administrator registration (section 2.2), Key user management concepts in CTIS (section 3.1), Data, documentation, and processes (section 7), Safety reporting obligations (section 9), Support (section 10), Other references (section 11) were also updated in this version of the handbook.

More information can be found here.