SK Official website

Ethics Committee for Clinical Trials

Ethics Committee for Clinical Trials

Status:
Statute:

Status of the Ethics Committee for Clinical Trials for Human Medicinal Products, Medical Device Clinical Trials and in vitro diagnostic medical device performance study (also published in the MZSR 2021 (Amount 31-35- 17https://www.health.gov.sk/?vestniky-mz-sr)

List of members of the Ethics Committee for Clinical Trials:
List of members of the Ethics Committee for Clinical Trials:

Import Page 2180 - Table 1

Name of member of the commission Function
1. Dr Aurelia Mozeshová President of the Ethics Commission
2. PharmDr. Anna Oleárová, PhD., MPH Vice-President of the Ethics Commission
3. PharmDr. Lucia Plášková Permanent member of the Ethics Committee
4. PharmDr. Jana Babiak, PhD. Permanent member of the Ethics Committee
5. Dr Martina Hanzelová Permanent member of the Ethics Committee
6. PharmDr. Beata Keller Permanent member of the Ethics Committee
7. Dr Erika Timková Permanent member of the Ethics Committee
8. RNDr. Catherine Kollárová, PhD. Permanent member of the Ethics Committee
9. PharmDr. Luke Slovak, PhD. Permanent member of the Ethics Committee
10. PharmDr. Michaela Hudec Permanent member of the Ethics Committee
11. Mr Zuzana Duliaková Permanent member of the Ethics Committee
12. PharmDr. Mary the Moschanian Permanent member of the Ethics Committee
13. Mgr. Ingrid Regiec Permanent member of the Ethics Committee
14. JUDr. Ivana Magdolenová Joríková Permanent member of the Ethics Committee

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Official name:
Official name:

Ethics Panel on Human Product Clinical Trials, Medical Device Clinical Trials and in vitro diagnostic medical device performance study

Contact:
Contact:

Email: eticka.comiseia@health.gov.sk
Address: Limbová 2– 837 52 Bratislava Slovak Republic
Tel.: +421 2 593 73 118

Information:
Information:

Annual EC reports:
EC Annual reports:

Documents to download:
Downloads:

Safety reports Þ general information:
Safety reporting – general information:

Clinical Trials Regulation 536/2014 – Safety reporting
Reporting/Reporting toSUSARASR/DSURUrgent safety measureSerious breakTemporary half/early terminationOthers*/Other *
ŠÚKL
(State Institute for Drug Control)		EVCTMCTISCTIS up to 7 days
(CTIS within 7 days)		CTIS up to 7 days
(CTIS within 7 days)		CTIS up to 15 days
(CTIS within 15 days)		CTIS up to 15 days
(CTIS within 15 days)
Ethics Committee for Clinical TrialsN/aCTISCTIS up to 7 days
(CTIS within 7 days)		CTIS up to 7 days
(CTIS within 7 days)		CTIS up to 15 days
(CTIS within 15 days)		CTIS up to 15 days
(CTIS within 15 days)

*Other/Other - all unexpected events that affect the risk/benefit ratio but are not classified as SUSAR (lack of effectiveness,
principal findings from animal studies, DSMC recommendation, SAR in a third country outside the clinical trial..)
- (all unexpected events that have an impact on the risk/benefit ratio, but are not classified as SUSAR (lack of effectiveness, essential finding)
from animal studies, DSMC recommendation, SAR in a third country outside of a clinical trial...)

The EVCTM (EudraVigilance ClinicalTrial Module) is the Eudravigilance module used for electronic reporting of SUSAR from clinical trials directly to the database.

Files to download

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