Clinical Trials Information System (CTIS)
The way that clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014) comes into application today, 31 January (2022).
The Regulation will harmonise the submission, assessment and supervision processes for clinical trials in the EU through the launch of a new, unified online portal known as the Clinical Trials Information System (CTIS). The CTIS will be a one-stop, single point of entry for the submission of clinical trial information in the EU and the European Economic Area (EEA).
For queries related to the CTIS, please contact the European Medicines Agency.
What CTIS will include:
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; as well as a public-facing website.
- 'Sponsor' secure workspace will assist clinical trial sponsors in preparing for and compiling clinical trial applications and related documents to submit for assessment.
- 'Authority' secure workspace will support the activities of EU Member States, EEA countries and the European Commission in assessing and overseeing clinical trials.
- Public website will allow the wider public to access detailed information on all clinical trials conducted in the EU and the EEA (when trials begin to be submitted and approved in CTIS).
Roles and responsibilities
- EU Member States and EEA countries will assess and supervise clinical trials in CTIS.
- European Medicines Agency (EMA) will set up and maintain CTIS.
- European Commission will ensure the correct interpretation and implementation of the Clinical Trials Regulation.
Transition to CTIS will take place over a three-year period.
- From go-live (January 2022): EU Member States and EEA countries will be required to work in CTIS once applications are submitted.
- From 31 January 2022 to 31 January 2023: clinical trial sponsors can choose to submit their clinical trial applications under the Clinical Trials Directive (EC) No. 2001/20/EC through national submission processes - or under the Clinical Trials Regulation through CTIS. Important to note: the National Office strongly encourages the research community to submit all new trials using 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 must be transferred to both the Clinical Trials Regulation and CTIS.
How clinical trials will be processed in CTIS
- Streamlining the submission process: clinical trial sponsors who wish to gain regulatory approval for a clinical trial in one or more EU Member State and EEA country will submit a single clinical trial application form and supporting dossier through CTIS. The submission must also include the public registration of the clinical trial.
- Supporting end-to-end business processes: CTIS will support the day-to-day business processes of EU Member States, EEA countries and sponsors throughout the lifecycle of a clinical trial by way of providing regulatory oversight of clinical trials and tools for supervision and monitoring.
How to register for CTIS
To access CTIS, clinical trial sponsors must ensure their users have an EMA account.
- Those that have an existing EMA account i.e. to use Eudravigilance or the substances, products, and organisations database (SPOR) do not need to create a new account.
- Those that do not have an EMA account can register via EMA Account Management. Clinical trial sponsors 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.
How to prepare for CTIS
- As a first step, we recommend clinical trial sponsors consult the sponsor handbook for guidance on preparing for CTIS. Tailored specifically for pharma, research organisations, SMEs and academic sponsors, it covers priority topics for clinical trial sponsors and links to supporting materials.
- Familiarise with the workings of CTIS by completing the online training programme. It consists of several modules covering the full lifecycle of clinical trial submission.
- Watch back on this information day that prepares CTIS users for submitting and evaluating clinical trial applications in the system when it goes-live.
Useful links to resources & training materials
- More information on CTIS: visit the EMA website
- Training and support on the use of CTIS: visit the CTIS training and support page on the EMA website
- Information on the functionalities of CTIS: visit the online modular training programme page on the EMA website
- Practical guidance to prepare for CTIS: consult the CTIS sponsor handbook
- Key information at a glance: read the CTIS newsletter series
- Detailed information on the Clinical Trials Regulation: visit the European Commission’s Eudralex Volume 10 clinical trials guidelines page
- FAQs on the Clinical Trial Regulation: read the European Commission's question and answer document
- Authorised documents under the new regulation: visit the European Commission’s clinical trials guidelines page