Safety reporting and Study Completion

Safety reporting

Sponsors are responsible for compiling lists of suspected cases of serious adverse effects identified in connection with trials each year (annual safety reporting) and for submitting these to the relevant Ethics Committee accompanied by reports on the safety of the subjects together with national coordinators’(i.e. person responsible for the study) opinion on the effects of the reported cases.

Study Completion

Sponsors and investigators must inform the relevant Ethics Committee of the completion of clinical trial on medicinal products within 90 days. If a trial is discontinued prematurely, notification with the reason stated must be submitted within 15 days. The end of trial notification can be done with spesific form (available at TUKIJA webpages), by EudraCT Declaration of End of Trial Form or by formal letter.