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EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
s of investigational medicinal products with at least one site in the
European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...
commencing 1 May 2004 or later. The EudraCT database has been established in accordance with
Directive 2001/20/EC The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementati ...
. The EudraCT Number is unique and is needed on other documents relating to the trials (e.g. SUSAR reports).


Public Side

The public side of EudraCT is for organisations to register any of their clinical trials as defined by
Directive 2001/20/EC The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementati ...
. The process of applying and registering a clinical trial should be completed before submitting an application to any of the Member State/s in which they anticipate running the trial. The public side of EudraCT does not save any of the trial detail entered by the user, and instead provides a saved data file in the form of an XML which the user must store on their own local hard drive.


Applying for an EudraCT Number

Application for an EudraCT number is made via the EudraCT website. To generate the EudraCT number some basic information about the requestor's organisation and the trial is required: * Requestor's organisation name, town/city and country. * Sponsor's protocol number. * Requestor name. * E-mail to which the EudraCT number will be sent. * Security code. * Whether the clinical trial is contained in a Paediatric Investigation Plan (PIP). * Whether the clinical trial will be conducted in a third country (outside of the EU/EEA). * The Member States where it is anticipated that the trial will be run. Once the requestor submits the form, the EudraCT Number will be assigned and an e-mail called "EudraCT Receipt" sent. The EudraCT number has the format YYYY-NNNNNN-CC, where: * YYYY is the year in which the number is issued. * NNNNNN is a six digit sequential number. * CC is a check digit. The Clinical Trial Application (CTA) form is also created via the EudraCT system.


Version details

The EudraCT database is currently on Version 9.


Current Versions

Version 9 of EudraCT was released in November 2013. New features for Version 9 include: Protocol-related information Sponsors can: * Create, save XML/PDF files of clinical trial applications locally. * Load locally saved clinical trial applications to complete, validate, compare, or to prepare a package for submission to a National Competent Authority. PIP addressees can: * Create, save XML/PDF files of third country files locally. * Create and post third country files to the EudraCT database. * Load locally saved third country files to complete, validate or post to the EudraCT database. To post third country files you will need to be registered as a PIP addressee. Result-related information * To use result related functionality you will need to be registered as a results user, and log in. Results users can: * Create, update, validate and post result data sets, and load summary attachments to the EudraCT database. * Save locally XML/PDF files of result data sets. * Upload XML files.


Member States

{, class="wikitable" , - ! Country !! Organisation !! Website , - , Austria , , Bundesamt für Sicherheit im Gesundheitswesen (BASG) , , http://www.basg.at/ , - , Belgium , , Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (AFMPS) , , http://www.fagg-afmps.be/ , - , Bulgaria , , Bulgarian Drug Agency (BDA) , , http://www.bda.bg/ , - , Croatia , , Agencija za lijekove i medicinske proizvode , , http://www.almp.hr/ , - , Cyprus , , Ministry of Health - Pharmaceutical Services , , http://www.moh.gov.cy/ , - , Czech Republic , , Státní ústav pro kontrolu léčiv (SÚKL) , , http://www.sukl.cz/ , - , Denmark , , Danish Medicines Agency (DKMA) , , http://laegemiddelstyrelsen.dk/ , - , Estonia , , State Agency of Medicines (SAM) , , http://www.ravimiamet.ee/ , - , Finland , , Fimea , , http://www.fimea.fi/ , - , France , , Agence Nationale de Sécurité du Médicament (ANSM) , , http://ansm.sante.fr/ , - , Germany , , Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) , , http://www.bfarm.de/ , - , Germany , , Paul-Ehrlich-Institut (PEI) , , http://www.pei.de/ , - , Greece , , National Organisation for Medicines (EOF) , , http://www.eof.gr/ , - , Hungary , , National Institute of Pharmacy and Nutrition (OGYÉI) , , https://www.ogyei.gov.hu/ , - , Iceland , , Lyfjastofnun (IMCA) , , https://web.archive.org/web/20111003224256/http://www.imca.is/ , - , Ireland , , Health Products Regulatory Authority (HPRA), , http://www.hpra.ie/ , - , Italy , , Agenzia Italiana del Farmaco (AIFA) , , http://www.agenziafarmaco.gov.it/ , - , Latvia , , Zalu Valsts Agentura (ZVA) , , http://www.zva.gov.lv/ , - , Liechtenstein , , Amt für Gesundheit (AG) , , https://web.archive.org/web/20111024152641/http://www.ag.llv.li/ , - , Lithuania , , Valstybine Vaistu Kontroles Tarnyba (VVKT) , , http://www.vvkt.lt/ , - , Luxembourg , , Division de la Pharmacie et des Medicaments , , http://www.etat.lu/MS , - , Malta , , Medicines Authority , , http://medicinesauthority.gov.mt/ , - , Netherlands , , Centrale Commissie Mensgebonden Onderzoek (CCMO) , , http://www.ccmo.nl/ , - , Norway , , Statens Legemiddelverk (NOMA) , , http://www.noma.no/ , - , Poland , , Urząd Rejestracji Produktów Leczniczych (URPL) , , http://www.urpl.gov.pl/ , - , Portugal , , Autoridade National do Medicamento e Produtos de Saude I.P. (Infarmed) , , http://www.infarmed.pt/ , - , Romania , , Agentia Nationala a Medicamentului si Dispozitivelor Medicale (ANMDM) , , https://www.anm.ro/ , - , Slovakia , , Slovakia Medicines Agency , , http://www.sukl.sk/ , - , Slovenia , , Javna Agencija Republike Slovenije za Zdravila in Medicinske Prioimocke (JAZMP) , , http://www.jazmp.si/ , - , Spain , ,
Agencia Española de Medicamentos y Productos Sanitarios The Spanish Agency of Medicines and Medical Devices ( es, Agencia Española de Medicamentos y Productos Sanitarios; AEMPS) is a regulatory and autonomous agency of the Government of Spain that acts as the highest sanitary authority in the countr ...
(AEMPS) , , http://www.aemps.gob.es/ , - , Sweden , , Lakemedelsverket , , http://www.lakemedelsverket.se/ , - , UK , , Medicines and Healthcare Products Regulatory Agency (MHRA) , , http://www.mhra.gov.uk/
Source


See also

*
European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
*
EUDRANET EUDRANET, the European Telecommunication Network in Pharmaceuticals (European Union Drug Regulating Authorities Network), is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and eval ...
*
EudraGMP EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. Access for the general ...
*
EudraPharm EudraPharm (European Union Drug Regulating Authorities Pharmaceutical Database) was the database of medicinal products authorised in the European Union, and included the information contained in the Summary of Product Characteristics, the patient ...
*
EudraVigilance EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or bein ...


External links


EudraCTInternational Standard Randomised Controlled Trial Number Register
(ISRCTN)
EU Clinical Trials Register
(EU-CTR) European clinical research Clinical data management Health and the European Union