The Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on Medical devices clinical investigations during the COVID-19 outbreak.
The guidance was first published on March 30th, 2020.
In the last update of May 7th, a new section on Clinical investigations during COVID-19 has been added:
– The priority is the safety of participants of clinical investigations and this will remain our focus. Therefore, carefully document all actions and risk assessments you take in response to COVID-19 to determine the impact.
– If a clinical investigation needs to be paused, notify us as soon as possible, and keep good records of your actions.
– The impact of COVID-19 will likely increase by protocol deviations. You should maintain good records of these deviations. Unless there is an impact on patient safety, you do not need to notify MHRA of COVID-19 related deviations.
For more detail please see the original communication from MHRA.
Contents of the guidance:
- Ongoing clinical investigations
- New submissions for clinical investigations
- Clinical investigations about COVID-19
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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