Notification of a clinical trial - EudraCT
- Apply for a EudraCT number
- Fill in, save and print the notification form
- Submit the CD-ROM and the signed printout to the Finnish Medicines Agency, Fimea
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 -> EEA). 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. The completed notification form shall be saved as an electronic file in the .xml format. This file shall be saved on a CD-ROM and a printout of the form should also be provided. From 1.1.2017 the notification (and the appendices as required in the Regulation 2/2012) should be sent as a paper version and on CD to the following address:
Finnish Medicines Agency
P.O. Box 55
After checking the information, the Agency shall submit the EudraCT file to the official EudraCT database.
Notification of protocol amendments and of study completion
When 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. The forms may be filled in electronically on the EMA website, but Fimea requires submission of signed paper printouts.