Organisation Management Service
CTIS retrieves organisation data from Organisation Management Service (OMS). The organisations that need to be registered in OMS in order to be available for CTIS are sponsors, co-sponsors, third party contractor (e.g. CRO), and marketing authoristation holders. Clinical trial sites (in the EEA) do not need to be registered first in OMS, but can be taken up in CTIS directly.
If an organisation is not yet registered in OMS when starting to use CTIS, it is necessary to register the organisation via a request in OMS. Access to OMS is on the EMA SPOR portal (SPOR means: Substance, Product, Organisation, Referentials management services). The registration process of a new organisation in OMS takes from five to ten working days.
Further guidance, see CTIS training module 3 and CTIS Sponsor handbook chapter 3.