Create a EudraCT number

To create a clinical trial application, you must first apply for 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. number.

Please note: In the event a clinical trial application and a third country file should be prepared for the same clinical trial, the same EudraCT number must be used.

From the login page, select Create> EudraCT NumberWhen registered, each trial is issued with a unique EudraCT number, which identifies the protocol and trial throughout its lifespan. and the following page is displayed:

Note:Fields with an asterisk * are mandatory and must be input.

  1. Enter the name of the organisation.
  2. Enter the town/city in which the organisation's office is located in the Requestor's organisation town/city field. This should relate to the office where the particular planned clinical trial is to be run from (rather than the global headquarters.).
  3. Select the country in which the organisation's office, is located from the drop down list
  4. Enter the sponsor's protocol code number in the format specified by your organisation. This is the protocol code number for the clinical trial that will be linked to the EudraCT number obtained from this request. This is not generated by the EudraCT system. If you are unsure what this value is, contact the sponsor of the clinical trial.
  5. In the Requestor name/last name field, enter your first and last name.
  6. Enter the e-mail address where the EudraCT number should be sent. Any valid e-mail address is acceptable.
  7. Enter the letters and numbers displayed in the window next to the text field. This field is case sensitive.If you cannot read the text in the picture, click the New Image button to refresh the image.
  8. If the EudraCT number is to be used for a clinical trial contained in a Paediatric Investigation Plan (PIP), tick the Yes radio button, otherwise click No
  9. If the EudraCT number is to be used for a clinical trial conducted in a third country (outside of the EUAcronym: European Union./EEAEuropean 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.), click the Yes radio button, otherwise click No
  10. Choose the country within the EEA where the clinical trial is expected to take place.
    To select multiple countries, hold CTRL and click each country in turn. Selected countries are highlighted light blue.
  11. Once the country(ies) is selected, click Copy.
  12. Click Get EudraCT number.
A EudraCT number is generated and shown on the web page. It is also sent to the specified email address at the same time. Click OK to return to the home page and create a clinical trial application.
 

Related Topics:

Clinical Trial Application Menu

Add Initial Required Information for EudraCT Number