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Clinical Trials Information System – CTIS

Message to sponsors transitioning clinical trials from CTD to CTR/CTIS

Clinical trials (CTs) authorised under the Clinical Trials Directive 2001/20/EC (CTD) likely to be ongoing beyond 30 January 2025 need to be transitioned to the Clinical Trials Regulation 536/214 (CTR). Details of the requirements for transitioning CTs are provided in the European Commission’s Guidance for the transition of clinical trials. Further ‘Best practice’ information and the required cover letter including annex template can be found at the homepage of the Clinical Trial Coordination Group, CTCG, unter key documents. For transitioning part II, please take care of the information by the Association of Medical Ethics Committees in Germany (AKEK).

The transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation is open to sponsors until the end of the 3-year transitional period, on 30 January 2025, without the need to discontinue a clinical trial or put a trial on hold. Clinical Trials transitioned need to be authorized by that date. Thereafter, an initial CT application of the ongoing CT will be necessary.

Sponsors should, however, take into account the time necessary for completion of the authorisation procedure under Chapter 2 of the CTR and the European Commission’s guidance. Therefore, sponsors are strongly advised to submit their applications prior to 30 January 2025 taking into account the assessment time, which can extend from 1 week (expedited process) to up to 106 days in case a full trial application is needed, also be aware of the winter clock stop between 22 December and 6 January.

By late October 2023, only around 390 transitional trials have been submitted to CTIS out of an estimated 4,000 - 6,000 trials pending to be transitioned by 30 January 2025.

Further resources and guidance from the European Medicines Regulatory Network are available on the CTIS website under the section “Transitioning Trials”) in order to support sponsors transitioning their trials to the CTR/CTIS.

Clinical Trials Regulation and CTIS

The manner clinical trials are conducted in the European Union (EU) has changed significantly since the Clinical Trials Regulation (Regulation (EU) No. 536/2014) came into force on 31 January 2022. The Regulation harmonises the submission, assessment and supervision processes for clinical trials in the EU through the Clinical Trials Information System (CTIS).

CTIS will be the single entry point for submitting clinical trial information in the EU and the European Economic Area (EEA). CTIS will contain a Sponsor workspace for clinical trial sponsors and the organisations that work with them, an Authority workspace for EU Member States, EEA countries and the European Commission, and a public website.

  • The Sponsor secure workspace will assist clinical trial sponsors in preparing and compiling the clinical trial application and related documents to submit for assessment.
  • The Authority secure workspace will support the activities of EU Member States, EEA countries and the European Commission in assessing and overseeing clinical trials.
  • Through the public website, members of the public can access detailed information on all clinical trials conducted in the EU and the EEA once trials start to be submitted and approved in CTIS.

EU Member States and EEA countries will assess and supervise clinical trials in CTIS, while EMA sets up and maintains CTIS. The European Commission ensures the correct interpretation and implementation of the Clinical Trials Regulation.

Transition period

The Clinical Trials Regulation foresees a 3-year transition period to CTIS.

  • From 31 January 2022 until 31 January 2023, clinical trial sponsors can choose to submit their clinical trial applications under the Clinical Trials Directive (EG) No. 2001/20/EC through national submission processes, or under the Clinical Trials Regulation through CTIS.
  • From 31 January 2023 all new clinical trial applications in the EU and EEA must be submitted under the Clinical Trials Regulation through CTIS.
  • From 31 January 2025 trials approved under the Clinical Trials Directive that are still ongoing will have to be transferred to the Clinical Trials Regulation and to CTIS.

EU Member States and EEA countries will have to work in CTIS from go-live, once applications are submitted.

FAQ CTIS

How clinical trials will be processed in CTIS?

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.

How to register for CTIS?

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.

Uploading of requested or revised documents in the context of validation or assessment.

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.

Are there shortened deadlines for mononational clinical trials?

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. 

Are there shortened deadlines for phase I studies?

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.

How to prepare for CTIS?

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,

Further Informationen

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