UK: MHRA launched Yellow Card website for reporting COVID-19 related issues
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched Yellow Card, a dedicated site for reporting COVID-19 related adverse medical device incidents and side effects from medicines.
You can report on Yellow Card if:
- a medicine causes side effects
- someone’s injured (or almost injured) by a medical device, either because its labelling or instructions aren’t clear, it’s broken or has been misused
- a patient’s treatment is interrupted because of a faulty device
- someone receives the wrong diagnosis because of a medical device
- a medicine doesn’t work properly
- a medicine is of a poor quality
- you think a medicine or medical device is fake or counterfeit
Anyone can report a problem.
For more details, please see the original communication from MHRA.
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.
