EudraCT Number: Identifier assigned by the European Medicines Agency Clinical Trials Database (EudraCT). For clinical trial applications to the UK, including . EudraCT is a database of all clinical trials which commenced in the Community from 1 May 2004, and also includes clinical trials linked to European paediatric drug development. Sponsor Name: The Institute of Cancer Research. With the entry in force of the EU Clinical Trials Regulation, ICMJE requirements will become a rule applicable to all studies. Full Title: Targeting cancer care with the use of genetic profiling. EudraCT ( E uropean U nion D rug R egulating A uthorities C linical T rials) is the European Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later. Medical device clinical trials for the assessment of conformity (type A) according to Art. It forms part of EudraPharm, the EU database of authorised medicinal products. Launched on 22nd March 2011 It contains Protocol related data on: - Clinical trials starting from 01.05.2004 - Phase II/III/IV Adult Clinical Trials with at least 1 site in the EU/EEA Sponsor Protocol Number: Start Date: 2017-03-17. Today, the registry holds information on over 30,000 trials. In October 2013 the European Medicines Agency (EMA) released a new version of the European Clinical Trials Database (EudraCT), marking "the initial step of a process through which summary clinical trial results will be made publicly available through the EU Clinical Trials Register (EU CTR)." Notably, the EudraCT summary results data . ICH GCP - EU Clinical trials Registry - ICH GCP. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Germany Germany's clinical trials registry, the DRKS, is available at www.drks.de. EudraCT Number: 2016-000869-23. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). The Clinical Trial Information System (CTIS) is the successor to the current European trial registry EudraCT. Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires responsible parties to register clinical trials and submit summary results to ClinicalTrials.gov. Sponsor Name: European Organisation for Research and Treatment of Cancer. The conduct of clinical trials in the EU is currently governed by the Clinical Trials Directive Search for available translations of the preceding link EN •••. A website that contains public information on interventional clinical trials medicines.For more information, see the European Union Clinical Trials Register. EU Clinical Trials Registry. Per GBR-71 and GBR-86, GBR-21 will harmonize the rules for conducting clinical trials throughout the EU. Application Submission. The training programme consists of several modules, covering the full lifecycle of clinical trial submission, authorisation and supervision. Sponsor Name: The Institute of Cancer Research. The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area. CTIS will be launched at the end of January 2022, and will gradually replace the existing European EudraCT trial registry for drug trials. The trial is now present in the EudraCT Secure website, however it is not yet public. In the UK, a favourable opinion given by a research ethics committee is subject to the clinical trial being registered. EudraCT Number: 2004-004273-28. EU Clinical Trials Registry. The EU Clinical Trials Register is part of EudraPharm, which is the community database of authorised medicinal products. Clinical Trial Review Process. Simple Search Click in the search field and enter a word or phrase (this is your 'search query'). EMA is delivering an online modular training programme to help clinical trial sponsors, national competent authorities, ethics committees, European Commission and EMA staff prepare for using the Clinical Trials Information System (CTIS). Sponsor Protocol Number: EORTC 08031. If the answer to your question is not here, please contact the Service Desk using the user credentials The European Union Clinical Trials Register allows you to search for protocol and results information on: interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA); clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development. EudraCT Number: 2016-000869-23. The Clinical Trials Regulation aims to simplify some of the rules and ensure that there is harmonisation between clinical trials conducted in all of the EU member states, enhance patient safety . Sponsor Protocol Number: EORTC 08031. Its launch is planned for late 2021. ClinicalTrials.gov - this is the US-based trial registry whose UK trials are also pooled in Be Part of Research. A first "cut" of the distribution of names by initial letter shows us that some letters are highly under . Europe's leading clinical trials conference focusing on partnerships, outsourcing, operations and technology is now 100% virtual. Also provide the ClinicalTrials.gov Identifier (NCT Number) for the expanded access record. 62 to 81 and the requirements of Annex XV apply. Full Title: Targeting cancer care with the use of genetic profiling. Trial sponsors will have to make trial results public on the registry (or registries) where the trial was originally registered within 12 months of trial completion. Our EU TrialsTracker has been assessing compliance with EU trial reporting guidelines for over a year now. European Clinical Trial Database (EudraCT) Registration. Given its distinct regulatory Investigators who are conducting trials covered by the FDAAA and 42 CFR Part 11 lock box provision and seeking consideration for publication in ICMJE journals can "opt out" of the lock box. Drivers to Conduct Clinical Trials Outside the USA 4. Post Brexit, the MHRA might be able to impose . The EU Clinical Trials Register currently displays 41435 clinical trials with a EudraCT protocol, of which 6803 are clinical trials conducted with subjects less than 18 years old. There are three types of medical device clinical trials that are subject to the requirements of the EU MDR. The EU Clinical Trials Register website provides the public with information held in the EU clinical trial database, EudraCT. Indeed, in article 25, paragraph 6 of the EU Clinical Trials Regulation, the EU will no longer authorize to support a Clinical Trials Application with data generated by a clinical trial which did not comply with this ICMJE requirement. Chinese Clinical Trial Registry (ChiCTR) Profile Website : Clinical Research Information Service (CRiS), Republic of Korea Profile Website : Clinical Trials Registry - India (CTRI) Profile Website : Cuban Public Registry of Clinical Trials(RPCEC) Profile Website : EU Clinical Trials Register (EU-CTR) Profile Website EU-SolidAct is a European, multicentre, randomized, parallel, phase 2 and 3 platform trial on drug interventions, both new and repurposed, single or in combination, in hospitalized adult patients with moderate or severe COVID-19, as defined by the WHO Working Group on the Clinical Characterisation and Management of COVID-191. It will be managed by the European Medicines Agency. The following tasks can be performed from this page: Create a EudraCT number. Subsequently, regulatory authorities around the world began to require the posting of clinical trial . A first "cut" of the distribution of names by initial letter shows us that some letters are highly under . Initially a non-public database, it was launched for the public as EU Clinical Trials Register in March 2011. EU Clinical Trials Registry. Is a confidential database of interventional clinical trials of medicinal products in the EU/EEA - initially accessible only to EU/EEA regulators; EudraPharm - Is the database of medicinal products authorised in the European Union, is a public source of information on medicinal products in the EU; EU Clinical Trials Register EU-CTR - Any trial of any medicinal product conducted since 2004 in an EU country has already been required to register on the European Union Clinical Trials Register (EUCTR), which is administered by the European Medicines Agency (EMA). The EudraCT database has been established in accordance with Directive 2001/20/EC. Sponsor Name: European Organisation for Research and Treatment of Cancer. Law Governing International Clinical Trials 5. Art. Sponsor Protocol Number: Start Date: 2017-03-17. It does not provide information on clinical trials for medical devices and procedures. The EudraCT database has been established in accordance with Directive 2001/20/EC.The EudraCT Number is unique and is needed on other documents . The EU Clinical Trial Register (EUCTR) is a public facing portal containing information on trials of medicinal products conducted in the European Union (EU) and European Economic Area (EEA). This information is provided by the sponsor of the clinical trial in electronic form (=application form) as part of the dossier submitted to the National Competent Authority concerned. THE EU CLINICAL TRIAL REGISTRY Scope of the Registry The European clinical trials database (EudraCT), managed by the EMA, is a database containing information on clinical drug trials conducted in Europe.b It was set up in 2004 as a confidential database with a public-facing registry, the EU Clinical Trials Register, launched in 2011. Enters the NCA and Ethics Committee approval date. The guidance makes clear that the UK will maintain existing EU trial reporting standards for drug trials immediately post Brexit. EU Clinical Trials Registry. The goal of the Clinical Trials Regulation is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information. ICH GCP - EU Clinical trials Registry - ICH GCP. The information contained in the EU Clinical Trials Register is extracted from EudraCT, the EU Clinical Trials database. The EU Clinical Trials Register is the publically available database of information extracted from EudraCT. Medical condition: Prostate Cancer. At the time of publication of this guideline the EudraCT data fields are for the most part consistent with international initiatives relating to clinical trial registries, e.g. Full Title: Targeting cancer care with the use of genetic profiling. 62 are subject to approval. 24th March 2011. by. Verified on December 9, 2021. It is a World Health Organization (WHO) recognized primary registry. Our data has been used by Parliamentary Committees and trial sponsors to improve the reporting of clinical trials registered on the EU Clinical Trials Register (EUCTR). Registry Identifier: Number assigned by a clinical trial registry (for example, a registry that is part of the World Health Organization [WHO] Registry Network); also required to enter the name of the clinical trial registry. Sponsor Protocol Number: Start Date: 2017-03-17. Examining all the trials on the EU Clinical Trials Register across 12 European countries (9,200 in total), we extracted the 1,903 trials with names. ICH GCP. EudraCT Number: 2016-000869-23. The clinical trials registered on this registry fulfill the . When providing registration information . An online register giving the public access to information on clinical trials authorised in the 27 EU Member States as well as Iceland, Liechtenstein and Norway has been launched by the European Medicines Agency (EMA). After removing redundancies, we ended up with a dataset of 718 unique trial names. The EU Clinical Trials Register search engine has been developed to allow searches for information entered into the European Union Drug Regulating Authorities Clinical Trials ( EudraCT) database. Start Date: 2005-11-15. EudraCT Number: 2016-000869-23. A webinar will introduce academia and small enterprises to the new Clinical Trials Information System (CTIS) and the incoming EU Clinical Trials Regulation. The training programme consists of several modules, covering the full lifecycle of clinical trial submission, authorisation and supervision. The International Committee of Medical Journal Editors announced a policy in 2004 that as a condition of publication, clinical trials would be required to be listed in a public registry [1]. ICH GCP. Examining all the trials on the EU Clinical Trials Register across 12 European countries (9,200 in total), we extracted the 1,903 trials with names. Users are reminded that phase 1 trials, conducted solely in adults and which are not part of an agreed PIP, are not public in the EU CTR. The European Union Clinical Trials Register (EUCTR) - this is the publicly available side of the European Union Drug Regulating Authorities Clinical Trials (EudraCT) database resulting from European Commission legislation. The European Union Clinical Trials Register provides access to trial protocols and summary trial results information for interventional clinical trials conducted in the European Union (EU) and the. However, it does not preclude sponsors of devices, especially those of drug-device combination products, from using this platform for . Since it launched in 2011, the EU Clinical Trials Register has consistently improved and expanded services to allow greater public access to information on clinical trials in the EU. EU Clinical Trials Register The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004. EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the European database for all interventional clinical trials on medicinal products authorized in the European Union (EEA) and outside the EU/EEA if they are part of a Paediatric Investigation Plan (PIP) from 1 May 2004 onwards. Click Search once you have entered a query in the field. Peter Mansell. Start Date: 2005-11-15. European Clinical Trial Register This is a primary WHO registry covering interventional clinical trials on medicines. Following our exit from the EU, the MHRA has been monitoring compliance with registration of trials of medicines in World Health Organisation recognised public databases, and reporting of trial summary results, and has been pro-active in contacting sponsors to ensure transparency expectations are met. Clinical trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of investigational medicinal products (IMPs). Listing of Clinical Trial Registries. The Regulation will require: consistent rules for conducting clinical trials throughout the EU;; information on the authorisation, conduct and results of each . The EU Clinical Trials Register gives users the possibility to search for information on any paediatric clinical trial, any EU Clinical Trials Register which consists of information from the EU Clinical Trial Database, EudraCT. The ICMJE does require public, prospective registration of clinical trials of all interventions, including devices. The EU Clinical Trials Register provides public access to information from the European Union (EU) clinical trial data-base (EudraCT). EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later. RESEARCH Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource Ben Goldacre,1 Nicholas J DeVito,1 Carl Heneghan,2 Francis Irving,1 Seb Bacon, 1 Jessica Fleminger,1 Helen Curtis1 ABSTRACT OBJECTIVES To ascertain compliance rates with the European Commission's requirement that all trials . EudraCT is used by national medicine regulatory authorities to support supervision of clinical trials and was established as a confidential database, in accordance with article 11 of . Challenges 6. Full Title: A phase II feasibility trial of induction chemotherapy followed by extrapleural pneumonectomy and postoperative radiotherapy in . Clinical trials The European Union Clinical Trials Register allows you to search for protocol and results information on: interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA); clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development. WHO International Clinical Trials Registry Platform (ICTRP) and the International Committee of Medical Journal Editors (ICMJE). The EU Clinical Trials Register, which draws on . EMA launches EU Clinical Trials Register. After removing redundancies, we ended up with a dataset of 718 unique trial names. Sponsor, once the trial is over: EudraCT is used by national competent authorities to support supervision of clinical trials and was established as a confidential database, in accordance with EU Clinical Trials Registry. (However, the process could equally be applied to, for example, EudraCT EU Clinical Trials Register, which permits you to download a page of results at a time, in .txt format - although you'd need to have created your own import filter for this (that will be covered here at some point in the future!)). It accepts interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA) as well as clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development. The website provides public access to information extracted from the European Union Drug Regulating Authorities Clinical Trials Database, EudraCT. All approved studies on coronavirus disease COVID-19 can be found through this link https://www.clinicaltrialsregister.eu/ctr-search/search?query=covid-19 In order to look for a study, click on "Home & Search". Registration of your clinical trial. Medical device clinical trials as PMCF investigation (type C . The information contained in the EU Clinical Trials Register is extracted from EudraCT, the EU Clinical Trials database. The UK's intention is to align transparency provisions with those currently operating in the EU, in order to eliminate the need for companies to duplicate . Addressing the . EudraCT Number: 2004-004273-28. These instructions are for PC. An agency of the European Union EU Clinical Trial Register (EU CTR) EU Clinical Trials Register. OBJECTIVES: To ascertain compliance rates with the European Commission's requirement that all trials on the EU Clinical Trials Register (EUCTR) post results to the registry within 12 months of completion (final compliance date 21 December 2016); to identify features associated with non-compliance; to rank sponsors by compliance; and to build a . Full Title: A phase II feasibility trial of induction chemotherapy followed by extrapleural pneumonectomy and postoperative radiotherapy in . The law applies to certain clinical trials of drug, biological, and device products and has been in effect since September 27, 2007. The trial is now public in EU CTR, with the exception of phase 1 trials conducted solely in adults, see frequently asked questions (FAQs). The UK has been leading the way in supporting and promoting transparency of clinical trials. From late 2021 onwards, all new drug trials (CTIMPs) starting up in Europe will have to be registered on CTIS rather than on EudraCT. This information is provided by the sponsor of the clinical trial in electronic form (=application form) as part of the dossier submitted to the National Competent Authority concerned. EudraCT Number 2010-023666-46 - Clinical trial results - EU Clinical Trials Register. ICH GCP. EudraCT is a database of all clinical trials conducted in the European Union from 1 May 2004 onward. ICH GCP. ICH GCP - EU Clinical trials Registry - ICH GCP. Trials that involve both UK and EU sites, there will be a record in the EU Clinical Trials Register (other than for adult Phase 1 studies). EMA is delivering an online modular training programme to help clinical trial sponsors, national competent authorities, ethics committees, European Commission and EMA staff prepare for using the Clinical Trials Information System (CTIS). ICH GCP. 2-4 November 2021, Nice, France. Explore 400,999 research studies in all 50 states and in 220 countries. Sponsor Name: The Institute of Cancer Research. The conduct of clinical trials in the EU is currently governed by the Clinical Trials Directive Search for available translations of the preceding link EN •••. May 28, 2015. Registro de ensayos clínicos de la UE. EudraCT & EU CTR Frequently asked questions This document provides answers to the most frequently asked questions received on the EudraCT database and on its public interface, the European Clinical Trial Register (EU CTR). Its EudraCT Number 2010-023666-46 - Clinical trial results - EU Clinical Trials Register. The EU Clinical Trials Register website provides the public with information held in the EU clinical trials database, EudraCT. Europe's largest event dedicated to streamlining clinical trials and improving the lives of patients The only meeting place to combine Partnerships, Outsourcing, Operations & Technology in Early and Late Phase Clinical . Full Title: Targeting cancer care with the use of genetic profiling. Sponsor Name: The Institute of Cancer Research. 2. International Clinical Investigators & Clinical Trials 3. We previously shared some of the data issues that make complete assessments of trials on the EUCTR difficult. ICH GCP - EU Clinical trials Registry - ICH GCP. The clinical trial information posted on EudraCT is available for public view on European Clinical Trial Registry (EU CTR). The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area. EU Clinical Trials Registry; EudraCT Number: 2004-003829-28: Sponsor Protocol Number: TAK-013/EC204: Start Date: 2004-12-22: Sponsor Name: Takeda Europe R&D Centre Ltd: Full Title: An open-label investigation into the tolerability and pharmacokinetic / pharmacodynamic effects of sufugolix (TAK-013), at a dosage of 100mg twice-daily, during . Recent improvements include the ability to search for . Clinical trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of investigational medicinal products (IMPs). 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