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.