Clinical trial sponsors who want to gain regulatory approval for a clinical trial in one or more EU Member States and EEA countries will submit a single clinical trial application form and supporting dossier through CTIS. The submission of the single clinical trials application form and supporting dossier will also include the public registration of the clinical trial.

CTIS will support the day-to-day business processes of EU Member States, EEA countries and sponsors throughout the lifecycle of a clinical trial. It will provide regulatory oversight of clinical trials and tools for supervision and monitoring.

Before using CTIS, users must have an EMA account. Users that have already an EMA account, for example to use Eudravigilance or the substances, products, organisations and referentials database (SPOR) do not need to create a new account. Users that do not have an EMA account can register via EMA Account Management.

Organisations may need to complete additional registration steps based on the user management approach they choose for CTIS. The organisation-centric approach allows for the management of users by an administrator at the organisation level rather than at the level of an individual trial. It is intended for organisations that will run several trials in CTIS. To make use of the organisation-centric approach, organisations must ensure they are registered in EMA’s Organisation Management System (OMS), and they must register a CTIS High Level Administrator via EMA Account Management.

If further, corrected or updated documents as part of the application have been requested as further information (RFI), the sponsor must upload them under the originally submitted document files. Uploading the documents as a direct response to the RFI in CTIS in the response area of the corresponding "Consideration" is not acceptable. Otherwise, these documents would no longer appear in the CTIS overview of uploaded documents as part of this application (initial application, substantial modification...) in the latest, most up-to-date version.

Validated clinical trial applications for mononational clinical trials are assessed within 26 days at BfArM. In case of no deficiencies the final trial authorisation is granted within 31 days at the latest. The Working Group of the German Medical Ethics Committees (Arbeitskreis Medizinischer Ethik-Kommissionen, AKEK) agreed to follow these timelines as well. 

Mononational phase I studies are assessed within 26 days after successful validation. Should the application be free of defects, a decision can be made by day 31. This also applies to other mononational studies of other phases.

Should it be a mononational and monocentric study, it will be examined on a case-by-case basis whether a shortening of the validation phase is also possible.

Sponsors can consult the CTIS Sponsor Handbook for guidance on how to prepare for CTIS.

In addition, sponsors can use the CTIS online training programme. The guide to the CTIS training material catalogue, which can be found on the training programme page on the EMA website, provides an overview of the training programme,