4 Safety and monitoring
4.1 Safety
NICE's patient safety oversight group recommends that time to antipsychotic medication and impact of electrocardiogram (ECG) result are monitored as safety indicators.
NICE and the Medicines and Healthcare products Regulatory Agency (MHRA) should be notified of any data collected that could indicate a safety concern, and the proposed response.
4.2 Monitoring
Technology developers must contact NICE:
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within 6 months of publication of this plan to confirm agreements are in place to generate the evidence
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annually to confirm that the data is being collected and analysed as planned.
Technology developers should tell NICE as soon as possible of anything that may affect ongoing evidence generation, including:
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any substantial risk that the evidence will not be collected as planned
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new safety concerns
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significant changes to the technology that affect the evidence generation process.
If data collection is expected to end later than planned, the technology developers should contact NICE to arrange an extension to the evidence generation period. NICE will withdraw the guidance if data collection is delayed without reasonable justification, or it is unlikely to resolve the evidence gaps.