Create Clinical Trial Application/Third Country CT Information

Task topic including steps necessary for initial creation of a Clinical Trial Application or Third CountryA third country is a country outside of the European Union/European Economic Area. Clinical Trial Information.

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. system is based on a set of web pages that collect the information required to complete a Clinical Trial application, save the data to disc, print paper copies for the National Competent Authorities (NCAAcronym: National Competent Authority) and Ethics Committees (ECAcronym: European Commission) and then make an electronic copy for despatch to the NCAAcronym: National Competent Authority. There are also facilities to download forms for “The Request for Authorisation of a Substantial Amendment to a Clinical Trial” and for the “Declaration of the End of a Clinical Trial”.
In order to create a Clinical Trial Application, the following prerequisites apply:
 
Prerequisites for creating a CTAAcronym: Clinical Trial Application
To create a Clinical Trial Application or add Third Country Clinical Trial Information, the following prerequisites apply:

Create the initial draft CTA

  1. Click , then select Clinical Trial.
  2. Finally, choose '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.', to specify where the Clinical Trial will take place.
    3. Tip: A Third CountryA third country is a country outside of the European Union/European Economic Area. is any country outside the European Economic Area (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.). The EEA contains member states of the EUAcronym: European Union., plus Iceland, Liechtenstein and Norway.Once the drop-down is open, press the first letter of the country to cycle through the possible results.
  3. The Initial Required Information section appears:
  4. Use the drop-down to select the National Competent Authority to whom the application is to be made from the drop-down list.
    Tip: Once the drop-down is open, press the first letter of the country to cycle through the possible results.
  5. Insert the EudraCT NumberWhen registered, each trial is issued with a unique EudraCT number, which identifies the protocol and trial throughout its lifespan. you applied for previously. This can be pasted or typed in full into the field.
  6. Click the button to create the draft Clinical Trial Application.
    Note: Click to return to the Welcome page.
Once has been clicked, the Clinical Trial Application Menu appears:

Now go to the "Clinical Trial Application Menu Overview" for more detailed information.

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