SLOVAKIA: SUKL issues guidance on patients´ risk assessment during COVID-19 emergency
The State Institute for Drug Control (SUKL) recommends some specific measures for the COVID-19 emergency.
Meditrial manages several studies in Slovakia and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support.
Any change due to COVID-19 can be implemented without authorization, although it must be notified by email without delay and accompanied by a detailed risk assessment.
The Sponsor shall notify the Institute in case the risk assessment affects the trial conduct.
The Institute follows a fast-track procedure for requests regarding COVID-19. For email requests, it is recommended to include ’COVID-19’ in the subject.
Helpline: +421 2 507 01 208
The guideline will be continuously updated. For more details, please see the official document.
Meditrial can help – Contact us for immediate support
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
Contact Meditrial for immediate assistance in Europe or the US.
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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.
