How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Document

    Do you have any further comments on the suitability of the proposed data collection study?

  • Question on Document

    Do you have any further comments on the acceptability of the suggested outcome measures to address the evidence gaps?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Evidence generation plan

Closed for comments This consultation ended on at   Request commenting lead permission

4 Monitoring

The company or technology developer 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 or technology developer 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 company or technology developer 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.