Notification of a clinical trial - EudraCT
Notification of a Clinical Trial - EudraCT
- Apply for a EudraCT number
- Fill in and save the notification form as .xml format
- The form in .xml format should be submitted electronically to Fimea together with a signed PDF
Applying for a EudraCT number
Apply first for a EudraCT number on the EudraCT website (Create -> EudraCT Number). The applicant shall fill in all compulsory fields marked with an asterisk. The EudraCT number will be sent to the applicant in an e-mail message. The same EudraCT number shall be used for multinational multicenter studies in all countries.
Filling in the EudraCT notification form
Once the EudraCT number has been provided for the trial, the applicant shall fill in a notification form on the EudraCT website (Create -> Clinical Trial Protocol -> EEA CTA). Instructions on how to fill in the notification form are available on the EudraCT website.
The form may be completed in Finnish, Swedish or English.
After checking the information, the Agency shall submit the EudraCT file to the official EudraCT database.
Notification of substantial protocol amendments and of study completion
When substantial amendments to the protocol are made, a Notification of Amendment form, available on the European Commission website, should be filled in; another form (Declaration of the end of a Clinical Trial) should be filled in at study completion.
clinicaltrials (a) fimea.fi