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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 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