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, 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.
