POLAND: Authorities suspend inspection of clinical trials till the end of April 2020 due to COVID-19
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland issued guidelines on clinical research under COVID-19.
Inspections activity of clinical trial is suspended until the end of April 2020. The decision to resume the inspection process will be taken depending on the epidemiological situation.
For more details, please see the English translation of the official communication in the attached document.
Meditrial manages several studies in Poland and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support.
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. Free Helpline +1-800-901-4286 helpline@meditrial.net
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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.
