A harmonized application form is used for clinical trial applications across the European Union.
EudraCT form (concerns only the EU)
The application form known as the “EudraCT application form”, completed and generated from the EudraCT online application, is the application form used for clinical trial applications in the European Union. The EudraCT form contains information on the clinical trial, the investigational medicinal product, the study design and the different actors involved (sponsor, applicant, CROs, central laboratories, investigators, etc.).
For most clinical trials, the EudraCT form is uploaded to the EU clinical trials register, making certain information on the trial available to the general public. The sponsor is required to maintain the EudraCT form up-to-date throughout the conduct of the clinical trial.