Evidence generation plan for digital technologies for applying algorithms to spirometry to support asthma and COPD diagnosis in primary care and community diagnostic centres: early-use assessment
4 Monitoring
NICE will contact the company:
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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.
The company 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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if the technology significantly changes in a way that affects the evidence generation process.
If data collection is expected to end later than planned, the company should contact NICE to arrange an extension to the evidence generation period. NICE reserves the right to withdraw the guidance if data collection is delayed, or if it is unlikely to resolve the evidence gaps.
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