General Information
SÚKL´s guideline KLH-21 is still valid only for Clinical Trial (CT) that goes under the Clinical trial directive 2001/20/EC (CTD). KLH-21 can be found here https://www.sukl.eu/medicines/medicinal-products-clinical-trials-guidelines-1
For submission of ASR/DSUR or report of domestic fatal case, that is not SUSAR you can use mail address posta@sukl
cz, CESP or data box.
For futher questions regarding safety in CTs contact Dr. Hruškova Reinova on mail eva.hruskovareinova@suklcz please refer to document Questions and Answers Document - Regulation (EU) 536/2014 – Version 5 (January 2022) on Eudralex-Volume 10 page (https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-10_en#set-of-documents-applicable-to-clinical-trials-that-will-be-authorised-under-regulation-eu-no-5362014-once-it-becomes-applicable
Submission of SUSARs
Since 2017 there is no requirement to send SUSARs to SÚKL in E2B.
All SUSARs should be reported directly to Eudravigilance database EVCTmodul. This will stay the same under Clinical Trial Regulation No 536/2014 (CTR). Therefore, for SUSAR reporting there is no change with CTR, and it applies for all clinical trials.
But be aware, that for clinical trials that go and are managed under the Clinical trial directive 2001/20/EC (CTD), SUSARs still need to be reported in the form of line listing to multicenter ethics committee.
Submission of ASR/DSUR
For clinical trials (CTs) that will be assessed and conducted per CTR ASR/DSUR should be submitted directly to CTIS (clinical trial information system)
For CTs that will be assessed nad conducted per Directive (CTD) ASR/DSUR should be submitted directly to SÚKL as per guideline KLH-21.
In case one clinical trial is ongoing in alignment with the Clinical Trials Regulation (EU) 536/2014 while others are under the Directive 2001/20/EC, an ASR should be submitted to the database specified in the regulation. Sponsors are allowed to name all MSs concerned for all ongoing CTs in EU/EEA within Directive as well as Clinical Trials Regulation. Sponsors are still obliged as of CT-3 to submit ASRs to Ethics Committees according to national legislations in MSs (in Czechia guideline KLH-21) with ongoing clinical trials within Directive 2001/20/EC and inform investigators of any new safety data or change in benefit-risk evaluation.
Reporting of fatal domestic event that is not SUSAR to SÚKL
After 31 Jan 2022 it is not required to report domestic fatal/death event directly to SUKL for CT that goes under the CTR.
For CT that goes under CTD, guideline KLH-21 is still valid, therefore Non-SUSAR Fatal Domestic events should still need to be reported within 7 days from its acknowledgement.
SÚKL has not any national template for reporting of domestic fatal/death event. You can use CIOMS or cover letter with valid description of the case. It can be in English or in Czech language, we accept both.
Department of Clinical Trials on Medicinal Products
Date: 10 February 2022
