What does EudraCT stand for?
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.
What kinds of trials require a EudraCT number?
EudraCT database covers only interventional clinical trials using investigational medicinal products (IMP) conducted in the EU/EEA and outside the EU/EEA if they are part of an agreed PIP (Paediatric Investigation Plan).
When should EudraCT number be applied for?
It is mandatory for clinical trial summary results to be posted in EudraCT within six to twelve months following the end of the trial (depending on the type of trial). It is the sponsor’s responsibility to ensure that this is done. Non-CTIMP research does not require a EudraCT number.
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 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 is in a clinical trial application?
A Clinical Trial Application provides comprehensive information about the investigational medicinal product(s) and planned trial, enabling regulatory authorities to assess the acceptability of conducting the study.
How do you 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.
Do I need to register on ClinicalTrials gov?
Which Trials Must Be Registered on ClinicalTrials.gov? Registration is required for studies that meet the definition of an “applicable clinical trial” (ACT) and either were initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007.
What is CTA vs IND?
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 sponsor’s protocol code number?
Advanced Search:
| Summary | |
|---|---|
| EudraCT Number: | 2020-001209-22 |
| Sponsor’s Protocol Code Number: | PRINCIPLE |
| National Competent Authority: | UK – MHRA |
| Clinical Trial Type: | EEA CTA |
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.
How can I find out more about EudraCT?
For more information, see the EudraCT website. A database that includes information on clinical trials taking place in the European Union and studies conducted worldwide accordance with a paediatric investigation plan. subset of data is publicly accessible via Clinical Trials Register. For more information, see the EudraCT website.
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).
Is there a technical notice on the EudraCT website?
The Joint Technical Notice to Sponsors by the European Commission, EMA and HMA was published yesterday on the European Commission health website. Essential maintenance work will be carried out to all EudraCT applications as part of EMA’s computer application maintenance work this weekend.