Organisation Management System (OMS) Trouble Shooting Session for CTIS users - November 2022
The Clinical Trials Information System (CTIS) is the single-entry point for clinical trial sponsors to submit their trials for authorisation and supervision in the EU / EEA. The system was created as part of the EU Clinical Trials Regulations (Regulation (EU) No 536/2014), to promote coordination and transparency in clinical trials.
Organisation Management System (OMS) is a workspace collaboration system used to support regulatory activities throughout the European Union (EU).
Starting on 30 June 2022, the EMA OMS team will provide monthly sessions to clarify outstanding questions reported by clinical trial user and clinical trial sites. EMA is offering this dedicated support to address issues and questions related to registering organisation and/or location data in OMS for use in CTIS clinical trial applications. This activity is a follow-up to the previously published OMS Industry training webinar.
Further communications will follow on calendar dates and other event details for future sessions in the next Clinical Trials Highlights newsletter.
A video recording is made available after the event. Processing and publication of the video recording typically take up to 60 days. Please subscribe to the Clinical Trials Highlights newsletter for updates on the availability of CTIS event video recordings.
For urgent clarifications on OMS processes and standards, please send your query via the EMA Service Desk