4 Monitoring

The companies 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 companies should tell NICE as soon as possible of 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 companies 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.