Added on 18 June 2024:
'CTIS transparency rules' section
CTIS serves 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 and European Commission.
CTIS supports interactions between clinical trial sponsors (researchers or companies that run a clinical trial and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.
Anybody can view information held in CTIS on clinical trials in the EU and EEA, by using the searchable public website.
Access the public information and secure workspaces in CTIS:
For more information on the legal framework, including a three-year transition period for clinical trial sponsors, see:
CTIS supports the business processes of clinical trial sponsors and national regulators via secure workspaces.
Access the secure workspaces in CTIS: |
Clinical trial sponsors can use CTIS to apply for authorisation to run a clinical trial in up to 30 EEA countries via a single online application.
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 collaborate on the evaluation and authorisation of a clinical trial in several EU/EEA countries.
They can also use it alongside other 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 single online portal for clinical trial sponsors and other organisations involved in running clinical trials to apply to carry out a trial in the EU Member States and EEA countries, submit data related to a trial and post trial results.
Access the sponsor workspace in CTIS: |
It has the following functionalities:
It is for the following target users:
For more information, see the infographic for sponsors:
The authority workspace enables EU Member States, EEA countries and the European Commission to use CTIS to oversee the conduct of clinical trials in the EU/EEA.
Access the authority workspace in CTIS: |
It has the following functionalities:
It is for the following target users:
The public website has a search function which anybody can use to find detailed information on clinical trials from 31 January 2022, based on the information contained in the Clinical Trials Information System (CTIS).
Search for information in CTIS via the link below:
Via this website, anybody can view information on individual clinical trials as soon as it becomes available, such as the following:
Initially, the website gives access to information on a limited number of clinical trials, however the volume of trial-related information will increase as sponsors and regulators use CTIS to initiate and oversee clinical trials, in line with a three-year transition period under the Clinical Trials Regulation.
Information on individual clinical trials initiated before 31 January 2023 under the Clinical Trials Directive is available:
The Clinical Trials Regulation requires information stored in the CTIS database to be publicly available, unless exempted to protect the following:
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:
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.