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  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    Are there any equality issues that need special consideration and are not covered in the medical technology consultation document?

  • Question on Document

    Are there any other relevant ongoing studies that address the evidence gaps?

Evidence generation plan

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4 Monitoring

The company must contact NICE:

  • within 6 months of publication of this plan to confirm agreements are in place to generate the evidence

  • annually to confirm that the data is being collected and analysed as planned.

The company should tell NICE as soon as possible about anything that may affect ongoing evidence generation, including:

  • any substantial risk that the evidence will not be collected as planned

  • new safety concerns

  • the technology significantly changing 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.