Table 2.

STOP/REVIEW/GO criteria for the internal pilot

	Red - STOP	Amber - REVIEW	Green – GO
Total number of participants recruited after completion of the internal pilot	0–44 participants (< 60% of recruitment target)	45–74 participants (60–99% of recruitment target)	>=75 participants (> = 100% of recruitment target)
Actions	Stop – unless demonstratable mitigating circumstances and strategies to mitigate and improve recruitment	Discuss with TMG and TSC strategies to improve recruitment, including additional sites and proceed with funder permission	Proceed