Clinical Trials Information System | European Medicines Agency (2024)

CTISserves to implement EU pharmaceutical law in the Clinical Trials Regulation(Regulation (EU) No 536/2014).

The European Medicines Agency (EMA) maintains CTIS and the public website, together with the EU Member States, EEA countries andEuropean Commission.

CTIS supports interactions betweenclinical trial sponsors (researchers or companies that run a clinical trial and collect and analyse the data)andregulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.

Anybody can view informationheld in CTISon clinical trials in the EU and EEA, by usingthesearchablepublic website.

Access the public information and secure workspaces in CTIS:

• Clinical Trials website

For more information on the legal framework, includinga three-yeartransition period for clinical trial sponsors, see:

• Clinical Trials Regulation

• Development of the Clinical Trials Information System

CTISsupports the business processes of clinical trial sponsors and national regulators via secure workspaces.

Clinical trial sponsors can use CTIS to apply for authorisation to run a clinical trial in up to 30 EEA countries via a single onlineapplication.

They can also carry out tasks including liaising with national regulators while a trial is ongoing and recording clinical trial results.

National regulators can use CTIS to collaborateon the evaluation and authorisation of a clinical trial in several EU/EEA countries.

They can also use it alongsideother systems to work together on clinical trial oversight, including monitoring and assessing safety-related data in the context of a clinical trial.

The sponsorworkspace is a singleonline portalfor clinical trial sponsors and other organisations involved in running clinical trialsto apply to carry out atrial in theEU Member States and EEA countries, submit data related to a trial and post trialresults.

It has the following functionalities:

• Manage users and user roles
• Compile clinical trial applications for new and updated trials
• Cross-reference to product documents in other clinical trials
• Submit clinical trial applications for assessment by Member States
• Receive alerts and notifications for ongoing trials in CTIS
• Respond to requests for information and view deadlines
• Search and access clinical trials
• Issue notifications related to key milestones in the trial lifecycle (e.g. start of recruitment, end of recruitment)
• Record clinical trial results
• Submit annual safety reports

It is forthe following target users:

• Clinical trial sponsors
• Marketing authorisation applicants and holders
• Other organisations involved in running clinical trials

For more information, see the infographic for sponsors:

The authorityworkspace enables EU Member States,EEA countries and the European Commission to use CTIS to overseethe conduct of clinical trials in the EU/EEA.

It has the following functionalities:

• Manage users and user roles
• View clinical trial application dossiers
• Manage tasks related to the assessment of clinical trials
• Collaborate within and between Member States
• Receive alerts and notifications for ongoing trials in CTIS
• Download documents submitted by clinical trial sponsors
• Record inspections of sites and clinical trials
• Conduct Union controls
• Assess annual safety reports

It is forthe following target users:

• National competent authorities of EU Member States and EEA countries
• Ethics committees of EU Member States and EEA countries (national processes regarding access to CTIS for ethics committees may vary)
• European Commission

The public website has a search functionwhich anybody can use tofind detailed information on clinical trials from 31 January 2022, based on the information contained in the Clinical Trials Information System (CTIS).

Search for information inCTIS via the link below:

• CTIS public portal: search for clinical trials

Via this website, anybody can view information on individual clinical trials as soon as it becomes available, such as the following:

• EU clinical trial number
• Therapeutic area
• Detailsof the trial sponsor
• Start and end dates of participant recruitment and of the trial itself

Initially, the websitegives access toinformation on a limited number ofclinical trials, however the volume of trial-related informationwill increase assponsors andregulators use CTISto initiate and oversee clinical trials, in line with athree-year transition period under the Clinical Trials Regulation.

Information on individual clinical trials initiated before 31 January 2023 under the Clinical Trials Directiveis available:

• European Union Clinical Trials Register

The Clinical Trials Regulation requires information stored in the CTIS database to be publicly available, unless exempted to protect the following:

• Personal data
• Commercially confidential information (in particular the marketing-authorisation status of a medicine, unless there is an overriding public interest)
• Confidential communication between EU Member States during evaluations
• Supervision of clinical trials by EU Member States.

Information on clinical trials submitted in CTIS is made available on the CTIS public portal, in line with revised CTIS transparency rules applicable as of June 2024.

To consult the revised rules, see:

• Development of the Clinical Trials Information System: CTIS transparency rules

A joint controllership arrangement describes the processing of personal data in CTIS, in accordance with the General Data Protection Regulation and EU Data Protection Regulation.

A range of actors may need to enter personal data into CTIS as part of clinical trial authorisation and supervision processes, including clinical trial sponsors, marketing authorisation applicants or holders, the European Commission, EMA, EU Member States and EEA countries.

The joint controllership arrangement describes the roles and responsibilities of each party regarding the processing of personal data in CTIS. It sets out the measures they must put in place to ensure that personal data in CTIS is securely processed, and covers how the parties are to handle any personal data breaches.

When accessing CTIS for the first time, CTIS workspace users will be made aware of the contents of the joint controllership arrangement before proceeding.