The public area of the EudraCTEudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all interventional clinical trials of medicinal products commencing in the European Union from 1 May 2004 onwards. The EudraCT database has been established in accordance with Directive 2001/20/EC.EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all interventional clinical trials of medicinal products commencing in the European Union from 1 May 2004 onwards. The EudraCT database has been established in accordance with Directive 2001/20/ECEuropean Commission. system allows all applicants to create a EudraCT number, draft, validate, compare, and submit clinical trial applications to National Competent Authorities and Independent Ethics Committees.
If it is a third country file and the requisite third country data provider login has been provided to the applicant then completed CTAs files can be posted directly to the EudraCT database.
Please Note:The third country data provider role encompasses two roles, namely the PIP addressee and the Article 46 data provider.
https://eudract.ema.europa.eu/
It also offers third country data providers secure access to allow them to draft, validate, and post third country clinical trial information.
The public area of EudraCT allows sponsors, third country data providers and MAH(s) to log into the system to prepare and post result related information of clinical trials.
To access result related functionality you need to be registered as a results user and logged in.
The secure area of the EudraCT system allows users to create a EudraCT number, to validate, compare and submit clinical trial applications using content supplied by applicants through the EudraCT public submission package creation process. It also offers options to upload the NCANational Competent AuthorityNational Competent Authority’s and ethics committee decision/opinion, as well as amendments and end of trial declarations.
Finally, it provides a portal for inspectors to perform their tasks of adding, loading, editing and saving information related to inspections.
Related Topics:
Logging in to the EudraCT system
22/03/2017