4 Monitoring
Technology developers are required to contact NICE:
-
within 6 months of the evidence generation plan's publication to confirm that agreements are in place to generate the evidence specified
-
annually to confirm that the data is being collected and analysed as planned.
Technology developers should inform NICE at the earliest opportunity of anything that may affect ongoing evidence generation, including:
-
any substantial risk that the evidence will not be collected as planned
-
new safety concerns
-
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 reserves the right to withdraw the guidance if data collection is delayed, or if it is unlikely to resolve the evidence gaps.