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Table 1 Outcome measures by project management phases

From: Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial

Project management phaseProject outcome measures
Initiation• Time from REB submission to approval
• Grant success rate
• Time to first enrolment
Planning• Time from site REB submission to approval
• Time from site contracts submissions to approval
• Number of and types of personnel trained
• Number of training sessions
• Materials prepared by the Methods Centre
• Time to first enrolment
Execution• Consent rate overall
• Enrolment rate per month per site
• Proportion of trained personnel who performed trial activities
• Number of case report forms completed
• Data query rate
• Time to clean data
Monitoring and controlling• Intervention fidelity by site
 • Intervention delivery (e.g. cycling)
 • Primary outcome measure collection (e.g. PFIT-s)
• Number of recruitment weeks lost and reasons by site
• Number of patients screened per 1 participant enrolled by site
• Number of eligible non-randomized patients and reasons
• Number of in-person training sessions required after start-up