Evidence generation plan
Closed for comments This consultation ended on at Request commenting lead permission
4 In the context of evidence generation, it is key to consider as part of the informed consent process that patients (and their carers, as appropriate) understand that data will be collected to address the evidence gaps in section 2. Where applicable this should take account of NICEs guidance about shared decision making.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 of anything that may affect ongoing evidence generation, including:
any substantial risk that the evidence will not be collected as planned
new safety concerns
if 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.
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