Validate a CTA

Task topic including steps necessary for validating a Clinical Trial Application draft.

The system includes very few data consistency checks whilst the CTAcronym: Clinical Trial - A Clinical Trial Application becomes a Clinical Trial and is searchable within EudraCT once approved. Application form is being created. The application now allows users to validate the Clinical Trial Application based on predefined business rules.

These business rules may be reviewed online in 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. page.

• Click on the ‘EudraCT Validation Rules’ link in the User Guides section of the page.

• In the Clinical Trial Application Menu with the CTA (EEAAcronym: European Economic Area. Created in 1994, the EEA combines the countries of the European Union and member countries of EFTA (European Trade Association) Countries that belong to the EEA are: Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom. Countries that are EEA member countries but NOT part of the European Union are: Norway, Iceland, and Liechtenstein. or Third CountryA third country is a country outside of the European Union/European Economic Area.) in XMLAcronym: eXtensible Markup Language format associated with a EudraCT NumberWhen registered, each trial is issued with a unique EudraCT number, which identifies the protocol and trial throughout its lifespan. for the same draft CTA currently loaded in the EudraCT system.
• The CTA Information window on the left of the screen indicates which CTA is currently loaded:

• All users of EudraCT may perform a validation on a CTA.

1. In the Clinical Trial Application Menu the Task Bar at the top of the screen includes the option 'Validate':
Note: If this option is not available to you, please check the prerequisites above are met.
2. Click and the loaded CTA is validated against the business rules and the Application Validation Results screen appears.
Note: It is recommended that Internet Explorer is used to ensure the formatting of the report displays correctly. There are known issues surrounding the display of the reports within Firefox.
The subsection is now complete.

Now go to the Review Validate Application Results section below for more detailed information on reviewing and understanding the Validate Application Results.

Review Validate Application Results

This sub-section is intended to provide information on reviewing the Validate Application Validation Results screen:

• The précis total details the number of sections where inputs to the CTA failed the business rules as well as providing a total number of inconsistencies within the entire CTA (e). In the above example, 83 business rules were not met.
• To expand an individual section, click the arrow alongside a particular section. The folder expands (click the arrow again to close the section).
• To drill down further click subsequent arrows.
• Alternatively, use the Expand All / Collapse All links at the top of the Validation Results page.

Note: Whilst it is hoped that the validation process will enable applicants to submit CTAs that adhere to all of the business rules, it is appreciated that this may not always be possible. For this reason, applicants may still create a submission package with a CTA that does not meet the validation rules. It is expected that such issues are kept to an absolute minimum, and should be accompanied by an explanation in the covering letter for the submission. This will help NCAs and IECAcronym: Independent Ethics Committee ensure a more efficient processing of the Clinical Trial Application.

The validation process is now complete. You may now click at the bottom of the screen to save the entire report 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. document or click to go back to the Clinical Trial Application Menu.

Validation Application Results is designed to ensure the quality and compliance of Clinical Trial Applications. Click to go back to the Clinical Trial Application Menu.

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.