Table 3.
Stop | Amend | Go |
---|---|---|
If one or more of the criteriaa meet the ‘stop’ thresholds, then the study should not progress towards a definitive cRCT, unless there are clear ‘modifiable’ contextual or design issues (i.e. related to the intervention or study procedures) which have been identified | If one or more of the criteriaa meet the ‘amend’ thresholds, then these will be discussed with the TSC to ascertain whether there is enough evidence that sufficient improvements can be made to proceed to a definitive cRCT | If all the criteriaa meet the ‘go’ thresholds, then with the appropriate amendments (if needed), the study should proceed towards a definitive cRCT |
aBased on the criteria listed in Table 2