CTIS – Clinical Trial Information System at EMA launch January 2022

Written by Steen Ottosen

on 14 December 2021

Users are reminded that certain preparatory steps must be taken before it is possible to use CTIS.

Sponsor organisations opting for the organisation-centric approach that are not yet registered in EMA’s Organisation Management System (OMS) must do so before using CTIS.

Registration in OMS can be done by visiting the OMS webpage of the Substances, Products, Organisations and Referentials (SPOR) portal.

An EMA account with a SPOR user role is required in order to register an organisation in OMS.

Training materials for OMS can be found on the OMS webpage on the EMA website.

It is recommended to register in OMS as early as possible.

Sponsors can consult the Help section of the SPOR portal for details on guidance and support for OMS. Once registered in OMS, sponsor organisations opting for the organisation-centric approach must register their first high-level administrator, the Sponsor Administrator, via EMA Account Management prior to using CTIS. More information on registration can be found on the EMA Account Management home page.

The go-live of CTIS on 31 January 2022 is now less than two months away, and organisations throughout Europe and beyond are undergoing preparations for CTIS. Future users of CTIS are reminded of the available training and support materials, including the recently updated CTIS Sponsor Handbook, the principles for sponsor organisation modelling and personas documents, and the online modular training programme. T

CTIS will become the single entry point for submitting clinical trials information in the EU with the highest standards of safety for participants and increased transparency of clinical trial information.

It will support the day-to-day business processes of authorities and sponsors throughout the life-cycle of a clinical trial through collaboration tools, workflow, and reporting and document management capabilities.

CTIS is structured in two restricted and secured workspaces, only accessible to registered users, and a website openly accessible to the general public:

• The sponsor workspace, accessible to commercial and non-commercial sponsors. It supports the preparation, compilation and submission of clinical trial data for its assessment by Member States.

• The authority workspace, accessible to national competent authorities, ethics committees, the European Commission, and the European Medicines Agency (EMA). It supports the activities of Member States and the European Commission in assessing and overseeing clinical trials.

• The public website, accessible to patients, healthcare professionals, scientists, clinical research associations, media, and members of the public. It supports the open access to clinical trials’ data in the European Union, in line with the transparency goal set out in Regulation (EU) No 536/2014 (Clinical Trials Regulation).

To access CTIS restricted workspace, users need to have EMA Accounts. Users of other EMA applications (e.g. IRIS, EudraVigilance, SPOR) that have already created EMA accounts can use their credentials to access CTIS restricted workspaces. If an account is inactive for 6 months, it will be automatically deleted.

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