Czech Republic: Opinion of the SÚKL Department of Clinical Trials on ongoing clinical trials and on clinical trials not yet initiated in relation to COVID-19
The Czech Authority State Institute for Drug Control (SÚKL) updated its general recommendations respecting the current epidemiological situation with coronavirus regarding ongoing or not yet started clinical trials and the release of emergency measures of the government.
This opinion fully replaces opinions of 14.5.2020
The termination of emergency measures permitted by SÚKL was postponed until 31 August 2020 for areas with a higher incidence of COVID-19 (to date e.g. Karviná, Prague…). The sponsor should prove this fact in the documentation of the related site, eg from the website of the Ministry of Health of the Czech Republic: COVID ‑ 19: Overview of the current situation in the Czech Republic COVID disease according to the region.
For clinical trials in other areas with a low incidence of COVID-19, the termination of emergency measures applies as of 30 June 2020. Sponsors should switch to the normal regime without the use of the emergency measures.
For more information, please visit the SÚKL website (in local language).
Meditrial can help, Contact us now
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Table of Contents
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on [...]
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
