Prepare a Submission Package

Task topic including steps necessary for preparing a Submission Package, which is the deliverable that should be sent to the concerned NCAAcronym: National Competent Authority in the case of an 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. Clinical Trial Application or to an Independent Ethics Committee for their opinion.

In general this action should be performed only after the Clinical Trial Application or or Third CountryA third country is a country outside of the European Union/European Economic Area. Clinical Trial Information has been completed and validated.

Note:If the CTAAcronym: Clinical Trial Application has not been validated, please select the 'Validate' option at the top of the Clinical Trial Application Menu.

Prerequisites for Preparing a Submission Package:

To generate a 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. CTA Submission Package, the following prerequisite applies:

Clinical Trial information/CTA loaded (and preferably completed) in the Clinical Trial Application Menu, including all associated attachments.
All users of EudraCT may access this functionality if the above prerequisite is met.

In the Clinical Trial Application Menu the Task Bar at the top of the screen includes the option 'Package':
Click and the Prepare Clinical Trial Application Package screen appears:
Select your favoured language from English or Spanish using the Select Language drop-down, then click ‘Create Submission Package for Independent Ethics Committee’ or 'Create Submission Package for National Competent Authority'.

Note: If you are logged in as a PIP AddresseeThe PIP Addressee is the legal entity that has received the European Medicines Agency's decision on a Paediatric Investigation Plan (PIP)., only one option is given to 'Create Submission Package'.

A File Download dialogue appears (Windows Internet Explorer 8 in this example):
Select 'Save File' to save the file to your local area and use your local file system browser to choose a suitable location for the file, then click 'OK' button.

The Package is created automatically, with the following name convention “[EudraCT number] [Country of CTAcronym: Clinical Trial - A Clinical Trial Application becomes a Clinical Trial and is searchable within EudraCT once approved.] [YYYYMMDD] CTA Package.zip”: and is now stored locally and can be interacted with and amended within other organisations ICT systems,or using widely available XMLAcronym: eXtensible Markup Language 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.

Applicants are now free to send the package to the relevant contact according to their business processes.

Note:A list of contacts is available on the EudraCT website documentation page under 'Member States' Contacts List' heading, here.

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 or Third Country Clinical Trial Information, if you do not need to prepare a submission package.