What is a EudraCT number?
A EudraCT number is a unique identifier of the trial and once. issued, it never expires. It identifies a specific trial.
How do I get a EudraCT number?
Researchers should apply via the EudraCT website by clicking ‘Login to EudraCT’ and then ‘Create’ and ‘EudraCT number’ before completing the registration form. The unique EudraCT number generated has the format YYYY-NNNNNN-CC, where: YYYY is the year in which the number is issued. NNNNNN is a six digit sequential …
How do I update EudraCT?
To update the results of a previous finalised clinical trial click the View posted and finalised results link on Your page: Click Edit: Edit any information for the trial and select Change update reason or additional information at the bottom of the page.
How do I post results on EudraCT?
To post results click on a clinical trial displayed on your page and click on Post Results:
- The following screen is displayed:
- Post full data set.
- If all the answers provided are correct, the user will be able to post the summary attachment, after having accepted the terms of agreement.
What is the EudraCT form?
EudraCT form (concerns only the EU) The EudraCT form contains information on the clinical trial, the investigational medicinal product, the study design and the different actors involved (sponsor, applicant, CROs, central laboratories, investigators, etc.).
What is an NCT number?
NCT Number: The National Clinical Trial number is an identification that ClinicalTrials.gov assigns a study when it is registered. The NCT number is in the format “NCTXXXXXXXX”. This includes any unique clinical study identifiers assigned by other publicly available clinical trial registries.
What kinds of trials require a Eudract number?
Member States
| Country | Organisation |
|---|---|
| Germany | Paul-Ehrlich-Institut (PEI) |
| Greece | National Organisation for Medicines (EOF) |
| Hungary | National Institute of Pharmacy and Nutrition (OGYÉI) |
| Iceland | Lyfjastofnun (IMCA) |
What does Isrctn stand for?
International Standard Randomised Controlled Trial Number
Originally ISRCTN stood for ‘International Standard Randomised Controlled Trial Number’; however, over the years the scope of the registry has widened beyond randomised controlled trials to include any study designed to assess the efficacy of health interventions in a human population.
What kinds of trials require a EudraCT number?
What is the equivalent of an IND in Europe?
In the United States, the initial submission to permit use of an investigational drug in a clinical setting is called an investigational new drug (IND) application. In the European Union, this documentation is submitted within a clinical trial application (CTA).
What is EV substance code?
EV CODE (EudraVigilance code) is a unique code assigned to any entity (e.g. substance, product etc.) entered in the XEVMPD. An EV Code is generated after the substance has been inserted successfully in the XEVMPD; the EV Code is included in the XEVPRM_ACK.
How do I contact NCT?
If you are unable to obtain an appointment at your chosen Test Centre then simply contact our call centre on 014135992. NCTS will do their best to accommodate you with a time and date that is convenient for you.
What does EudraCT stand for in clinical trials?
Welcome to the EudraCT public home page. 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.
Which is the latest version of the EudraCT database?
The European Medicines Agency has launched a new version of the European Clinical Trials Database (EudraCT). This new version, EudraCT V10, marks the final step of a process through which summary clinical trial results will be made publicly available through the EU Clinical Trials Register (EU CTR).
How to use results related functionality in EudraCT?
To use result related functionality you will need to be registered as a results user, and log in. 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. Load locally saved result data sets to update, validate, or to post to the EudraCT database.
What can I do with an EudraCT Number?
The following tasks can be performed from this page: Before any functionality of EudraCT can be used for a given clinical trial, a EudraCT number must be created in order to provide a unique reference for that trial. Create, save XML/PDF files of clinical trial applications locally.