Supervision

Serious Unexpected Adverse Reactions in Clinical Trials (SUSARs)

Reporting Adverse Reactions

Reporting Adverse Reactions

The sponsor must report all serious unexpected adverse reactions which are fatal or life-threatening as quickly as possible, however no later than within seven days of the sponsor being informed of such an adverse reaction. Any additional relevant information on such an adverse reaction must be reported within eight days of submission of the first notification.

Serious unexpected adverse reactions which are not life-threatening or fatal must be reported as soon as possible and in any case within 15 days of the sponsor first being informed thereof.

EudraVigilance

Registration with EMA’s EudraVigilance is mandatory for commercial sponsors. Registration instructions are available at the EudraVigilance website (http://eudravigilance.ema.europa.eu/Decommissioned/Decommissioned.html). Registered sponsors must submit electronic notifications to EudraVigilance.

Unexpected serious adverse reactions occurring both in Finland and abroad must be reported to the European Medicines Agency (recipient identifier EVCTMPROD). Specific instructions have been issued by the European Commission in the document titled “Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use” (‘CT-3’).

If the sponsor is not registered with EudraVigilance, a report must be made in writing to Fimea. The report may not be submitted by fax or email. It can be made in the form of a free-form letter or with the CIOMS-I form or a corresponding form. For more information what should be included in the report, please see current national regulation 8/2019.

Annual Safety Report

According to section 10g of the Medical Research Act, once a year, the sponsor must provide Fimea with a list of all suspected serious adverse reactions which have occurred during the period in question. At the same time, the sponsor must supply a brief report of the safety of persons participating in the clinical trial. The report shall take into account all facts relating to the trial, not only the safety of the investigational medical product. This requirement remains in force throughout the period the clinical trial is ongoing in Finland.

 

The sponsor must without delay inform the investigators and Fimea of any significant new observations relating to the safety of the investigational medicinal product.

Kliiniset haittavaikutukset yhteystieto

Further information:

clinicaltrials (a) fimea.fi