June 2021: CTIS Update

The third issue of CTIS Highlights was published on June 23, 2021.

It discusses two user management approaches (organization-centric and trial-centric) and the process of assigning roles in CTIS.

The other topics covered are CTIS system functionalities, Initial clinical trial application process in CTIS, Training Programme update and Audit updates. Additionally, it announces the availability of a CTIS Sponsor Handbook. EMA, in a collaborative approach including sponsor representatives, will prepare a sponsor handbook to provide sponsors with an overview of materials available to help them prepare for and use CTIS. A first version is expected to be published in Q3 2021.

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