Notification of a clinical trial - EudraCT
- Apply for a security code
- EudraCT number
- Fill in, save and print the notification form
- Submit the diskette and the signed printout to the Finnish Medicines Agency, Fimea
Applying for a security code and a EudraCT number:
Apply first for a security code (“Apply for Security Code”) on the EMEA website; the code is valid for 24 hours after its receipt. The applicant shall fill in all compulsory fields marked with an asterisk. The security code will be sent to the applicant in an e-mail message. The security code is used for applying for the EudraCT number (“Apply for EudraCT number”). The same EudraCT number shall be used for multinational multicenter studies in all countries.
Filling in the EudraCT notification form
Instructions on how to fill in the notification form are available in English (“EudraCT User Manual”) on the EMA website.
Once the EudraCT number has been provided for the trial, the applicant shall fill in a notification form on the EMA website (“Click here to create a new Clinical Trial Application”). 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 diskette and be sent together with a printout of the form to Fimea. After checking the information, the Agency shall submit it to the official EudraCT database.
Notification of protocol amendments and of study completion
When amendments to the protocol are made, a “Notification of Amendments” form, available on the EudraCT website, should be filled in; another form (“Declaration of the End of the 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. If the study has no EudraCT number, the EudraCT forms are still used but with the number provided by the Fimea (KL number) serving as the notification ID number.
If needed, more information is provided by:
Ilpo Lundberg, Clinical Trials Coordinator, tel. +358 9 47443 4328
Eija Mikkonen, Clinical Trials Coordinator, tel. +358 9 4733 4440
Paula Koivumäki, Clinical Trials Coordinator, tel. +358 9 4733 4335
Anu Puomila, Senior Researcher, tel. +358 9 4733 4325
E-mail addresses: firstname.lastname@fimea.fi.
Updated 1.2.2010