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).
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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