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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.
Is a EudraCT number required for the UK?
A EudraCT number is required in order to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a Clinical Trial Authorisation (CTA) and to apply for REC approval of your clinical trial. CTIMPS which began before 2021 will still need to register and report results on EudraCT.
How do I post results on EudraCT?
In order to post results in EudraCT, please follow the steps below: Set up an EMA account and use the new credentials to register as results user in EudraCT (log in using EMA credentials, click on “become a results user”, log out and log in again).
How do you find the EudraCT number?
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.
What is IND number in clinical trials?
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
How are clinical trials regulated in the UK?
∎ Clinical trials in the UK are currently regulated by the EU Clinical Trials Directive, which was transposed into UK law in 2004. The directive has been criticised for increasing the bureaucratic burden and cost of running trials in the EU. effect in 2019.
Is clinical trials Authorisation required?
For non-CTIMP research, a Clinical Trials Authorisation is not required.
What is NCT number in clinical trials?
National Clinical Trial 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”. Until an NCT number is assigned, the study is not registered.
What is the difference between IND and NDA?
The difference between IND and NDA It starts with an IND submission (after the pre-clinical activities are settled to gain approval to cross state lines and start clinical trials) and ends with the NDA submission to ensure all aspects of the drug are effective and ready to market in the USA.
What is EU CTR Regulation?
he European Union Clinical Trial Regulation 536/2014 (EU-CTR) aims to standardize and harmonize the conduct and management of interventional clinical trials across the European Economic Area (EEA), with legally binding rules on requirements and increased transparency.
Who regulates clinical research in the UK?
As per the MHCTR and the MHCTR2006, the Medicines and Healthcare Products Regulatory Agency (MHRA) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in the United Kingdom (UK).
What are regulatory authorities in clinical trials?
Regulatory authorities are responsible to review clinical trials of both non- registered medicinal substances and new indications of registered medicinal substances.
What is the difference between CTA and 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 regulatory in clinical trials?
For the purposes of clinical trials, regulatory approvals include any approvals by government or health authorities regarding any research that includes human subjects. Additional approvals will be necessary if the research involves the use of an FDA regulated product.
What is an NCT code?
A unique identification code given to each clinical study registered on ClinicalTrials.gov. The format is the letters “NCT” followed by an 8-digit number (for example, NCT00000419). Used For clinical trials.gov identifier Broader Term identifier.
What is EudraCT?
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 do I contact the EudraCT service desk?
Contact:EMA Service Desk portal telephone: (+31) (0) 88781 6000 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.
What can third country data providers do in EudraCT?
Third country data providers 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.
Why do I need a EudraCT Number?
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.