Getting the best from IRAS

8. EudraCT Import/Export

The Import / Export tab is only available on the MHRA Medicines (EudraCT application) form which you will need if you are applying for a Clinical Trial Authorisation (CTA) for a clinical trial of an investigational medicinal product (CTIMP).

The Import / Export tab allows you to import either all of the information or just the IMP information from the European Clinical Trials Database (EudraCT) into IRAS.

You can access the same functionality from the Import button on the ‘My Projects’ page.

Using IRAS in combination with EudraCT

  • Applicants can complete a EudraCT form through the EudraCT website first and then import the information into IRAS.
  • To import information from EudraCT you can either:
    • Select the MHRA Medicines (EudraCT application) form from the list of forms monitor and follow the instructions under the Import/Export tab; or
    • navigation page
    • Use the Import button on the ‘My Projects’ page monitor.
    • navigation page
  • Further guidance can be found on the IRAS Help pages available from the main menu.

Points to remember

  • Once a EudraCT number has been obtained it is possible to use IRAS to complete the whole EudraCT dataset and to save the application in the format required for submission to the MHRA.
  • Submission guidance is available from the Submission section of this guide and from the MHRA.
  • There is no need to export the data from IRAS to the EudraCT website in order to make an application to the MHRA.