ECSubmissionOfApplication object

Responsible for study submission

Sponsor

Prerequisites for submission / approval

Pre-Notification/ Application for a ruling (more info in 'Additional Information')

Guidance on study submission

TUKIJA has published a detailed guidance on the application procedure and related duties of the sponsor and investigator: “Operating procedures of the National Committee on Medical Research Ethics (TUKIJA) (Update May 2015)”

Additional Information

Pre-Notification: The first step in all clinical trials is for the sponsor to apply for a ruling from TUKIJA or by one of the regional EC. Sponsor can apply for a ruling on jurisdiction as soon as it becomes likely that the trial will be run in Finland, even if the actual application is not yet complete.
The application for rulings on jurisdiction shall be made to TUKIJA using the form “Prior notification of a clinical drug trial”, provided in Appendix 1 to Decree No. 841/2010 of the Finnish Ministry of Social Affairs and Health
(NB: Appendices are not available in the English version!).

Applicants are requested to submit the application in electronic format by email to TUKIJA’s secretary, considering the submission deadlines posted on TUKIJA’s website.

Depending on the ruling, which is communicated via email to the applicant, the sponsor then applies for an ethical review to be carried out either by TUKIJA or by the relevant regional EC.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395