Fimea provided guidance on trial monitoring plans during COVID-19 emergency.
Meditrial manages several studies in Finland and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support.
Monitoring activity
Sponsors are recommended to remotely monitor studies as much as possible (e.g. centralized monitoring). Deviation from the original monitoring plan to be documented and, in some cases, notified for protocol change.
More info can be requested via email.
For more details, please see a translated version of the original guideline.
Meditrial can help – Contact us for immediate support
Meditrial has developed rapid workflows to conduct a 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, legal, clinical, or compliance advice. Requirements and appropriate processes may vary by study, product, jurisdiction, and organization. Medigen Suite functionality should be used in accordance with applicable regulations, study documentation, and internal procedures.
