November 2021: CTIS Training Update

European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme, on November 15, 2021, by adding the below documents in CTIS Training Module 04 (Support with workload management):

  1. Step-by-step guide : Support with workload management in the authority workspace – Module 04 (v1.0): It describes the three workload functionalities- notices and alerts, tasks and, timetable and provides the step-by step guidance to be followed by the authority users to make use of these functionalities.
  2. Step-by-step guide : Support with workload management in the sponsor workspace – Module 04 (v1.0): It describes the three workload functionalities- notices and alerts, request for information (RFIs) and, timetable and provides the step-by step guidance to be followed by the sponsor users to make use of these functionalities.

Also, the new versions of the below documents from Module 01 (Introduction to the Clinical Trials Regulation (Regulation (EU) No 536/2014)) and Module 04 (Support with workload management) are now available:

  1. FAQs: Introduction to the Clinical Trials Regulation (EU) No 536/2014 – Module 01 (v1.2)
  2. Instructor’s guide: Introduction to the Clinical Trials Regulation (EU) No 536/2014 – Module 01 (v1.2)
  3. FAQs: Support with workload management by workspace – Module 04 (v1.2)

For more information, please click here.