Save a CTA or Third Country Clinical Trial Information as PDF

Task topic including steps necessary for saving a Clinical Trial Application or Third CountryA third country is a country outside of the European Union/European Economic Area. Clinical Trial Information as a PDFAcronym: Portable Document Format (PDF) is an open standard for document exchange. The file format created by Adobe Systems in 1993 is used for representing two-dimensional documents in a manner independent of the application software, hardware, and operating system. file.

The electronic submission of the Clinical Trial Application form to the National Competent Authority may be sent containing only the minimum mandatory information. The process to prepare this XMLAcronym: eXtensible Markup Language file within 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. application is detailed in "Purpose of EudraCT and the Clinical Trial Application".

In general this save should be performed following the preparation of the complete Clinical Trial Application or Third Country Clinical Trial Information if a paper or screen-based review of the Clinical Trial Application form is required.

Note: If the data is saved to an XML file and then the Clinical Trial Application system is exited without also saving the full CTAcronym: Clinical Trial - A Clinical Trial Application becomes a Clinical Trial and is searchable within EudraCT once approved. Application or Third Country Clinical Trial Information data, then any new data in the CT Application or Third Country Clinical Trial Information is lost.

Prerequisites for Creating a PDFAcronym: Portable Document Format (PDF) is an open standard for document exchange. The file format created by Adobe Systems in 1993 is used for representing two-dimensional documents in a manner independent of the application software, hardware, and operating system. of a CTAAcronym: Clinical Trial Application or Third Country CTIAcronym: Clinical Trial Information. As distinct from a CTA, CTI refers to Third Country Clinical Trial Information.:

To generate a PDF rendition of CTA, the following prerequisite applies:

A CTA or Third Country Clinical Trial Information loaded in the Clinical Trial Application Menu, including all associated attachments.
All users of EudraCT may access this functionality if the above prerequisite is met.
Internet Explorer users must ensure that their browser security settings are set to allow downloads:

In the Internet Explorer Menu Bar, click Tools>Internet Options>Security>Custom level...>then scroll down to the 'Downloads' settings, and select Enable for the Automatic Prompting for file downloads option:
Then click 'OK'.

To access this functionality, you need to be in the Clinical Trial Application Menu (log in, or in the middle of a draft CTA, for example). In the Clinical Trial Application Menu the Task Bar at the top of the screen includes the option 'Save as XML':
Click 'Save as XML' and a File Download dialogue appears (Windows Internet Explorer 6 in this example):
Click 'Save' to save the file to your local area and use your local file system browser to choose a suitable location for the file.

The CTA or Third Country Clinical Trial Information file, in XML format (i.e. it is a file with an '.xml' file extension) is now stored locally and can be interacted with and amended within other organisations ICT systems,or using widely available XML editors, though the changes can only be made within fields rather than to the file's overall structure if it is to be returned to EudraCT database in the future.

Now go to the "Clinical Trial Application Menu Overview" for more detailed information on other tasks that can be performed with your Clinical Trial Application.