European Union Clinical Trials Register
EU Clinical Trials Register
Omschrijving
In this Register, you are able to: •view the description of phase II to phase IV adult clinical trials where the investigator sites are in the EU/EEA; •view the description of any paediatric clinical trial with investigator sites in the EU/EEA; •view the description of any paediatric clinical trial that is sponsored by a marketing authorisation holder and involves the use of a medicinal product covered by an EU marketing authorisation in the paediatric population including trials conducted outside the EU / EEA; •view the description of any trials which form part of an agreed paediatric investigation plan (PIP) including those where the investigator sites are outside the EU/EEA; •view the summary results of the the clinical trials mentioned above; •view the summary results (with a reduced set of data fields) of paediatric trials completed by 26 January 2007 covered by an EU marketing authorisation; •download up to 50 results (per request) in a text file (.txt).
The details in the protocol related information include: •the design of the trial; •the sponsor; •the investigational medicine (trade name or active substance); •the therapeutic areas; •the status (authorised, ongoing or complete).
The details of the information of the summary results for a trial include: •the summary results in the form of datasets including: •trial information; •subject disposition; •baseline characteristics; •endpoints; •adverse events; •additional information; • summary attachment(s).
What is not available?
The EU Clinical Trials Register does not:
•provide information on non-interventional clinical trials of medicines (observational studies on authorised medicines);
•provide information on clinical trials for surgical procedures, medical devices or psychotherapeutic procedures;
•provide access to authorisation documents from national medicines regulators or the opinion documents from ethics committees;
•provide information on clinical trials where all of the investigator sites are outside of the EU/EEA, except for trials that formed part of an agreed (PIP);
•manage the process for joining a clinical trial published on the website;
•provide navigation and web content in languages other than English.
Formaat
Extra informatie
- Status
- voltooid
- Publicatiedatum
- 2016-11-16
- Type informatiebron
- Web service/API