Czech Republic Authority SÚKL issues clinical trial instructions for subject safety and data validity during COVID-19 emergency
The Czech Authority State Institute for Drug Control (SÚKL) has issued an opinion on a clinical research under current COVID-19 pandemic on 13 March and provided additional clarifications regarding the management of patients visits and study products on 16 March.
It is strongly recommended by the SÚKL not to initiate newly authorized clinical trials and enroll new patients in ongoing clinical trials in this critical period.
Meditrial manages several studies in the Czech Republic. Our teams are on the field with rapid access to the hospitals to make sure that patients receive adequate care. Please feel free to contact us for advice and support.
SÚKL instructions website
Specific questions can be addressed to MUDr. Alice Němcová, Director of Department of Clinical Trials on Medicinal Products (272 185 817, alice.nemcova@sukl.cz ) or MUDr. Ondřej Palán, Head of Clinical Trials on Pharmaceuticals Unit (272 185 327, ondrej.palan@sukl.cz)
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
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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.
