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