European Medicines Agency (EMA) updated the page Clinical Trials Information System: training and support, by adding a new version of Clinical Trial Information System (CTIS ) – Principles for Sponsor Organisation Modelling (v2.0) on October 29, 2021:
The updated version included the significance of CTIS user persona in mapping the different user roles, the two broad approaches for granting access to CTIS- centralized and decentralized approach, and an overview of the pros and cons for both these approaches.
It also provided examples explaining CTIS access, roles, and responsibilities of different user personas based on sponsor feedback for both simple and complex organization models with diagrammatic representation for each example. The complex models included examples related to co-sponsorship, multiple sponsors, and academic sponsors. At the end of the handbook, it provided a list of preliminary topics to be considered before implementing CTIS.
For more information, please click here.