Table 3.
Examples of coded reasons with matching and non-matching actions
| Slow Accrual Reason | Proposed Action | Action Matches Reason? |
|---|---|---|
| Strict eligibility criteria | Broaden eligibility criteria | Well matched |
| Extended delays for IRB/site activation | Activation/IRB approval at planned participating site | Well matched |
| High rate of screen failures | Promotion of trial – internal | Potential to influence |
| Longer than expected pre-specified halt/change to enrollment due to interim analyses, stopping rules, data review by DMC | Add new institutions | Does not match |
| Longer than expected pre-specified halt/change to enrollment due to interim analyses, stopping rules, data review by DMC | No action provided | Does not match |