A sponsor has asked if our EHR process has been accepted by the MHRA and "need to know the decision about this". I'm just wondering if any other NHS sites has received acceptance, and if so, how would you go about it.
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A sponsor has asked if our EHR process has been accepted by the MHRA and "need to know the decision about this". I'm just wondering if any other NHS sites has received acceptance, and if so, how would you go about it.
Please read the below blog from MHRA and may help you to understand the requirements of EHR from clinical trials perspective.
[URL]https://mhrainspectorate.blog.gov.uk/2019/07/23/electronic-health-records/[/URL]