UK: MHRA plans to restart on-site inspections as of September 2020
MHRA issued a guidance including the plan to resume on-site inspections next September and scale up to full on-site inspection program in October 2020. Onsite inspections in the UK halted in March due to the COVID-19 pandemic. If you have experienced any disruption to your clinical research due to COVID-19, please feel free to contact us for advice and support. Meditrial has direct connections with UK Investigators, hospitals and local Ethics Committees.
Keypoints:
- inspections at short or no notice: MHRA staff will discuss risk-mitigation measures upon their arrival
- pre-announced inspections: MHRA’s lead inspector will discuss risk assessment and logistics with the targeted organization to ensure compliance with government requirements.
- industries can implement technologies that enable remote access to information where possible. Videoconferencing may be used to interview a company’s employees.
For more details, please see the guidance from the MHRA.
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
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.
