Operational protocol review: translating science into site workflow
Translate protocol scientific requirements into practical site workflows, identifying visit schedules, procedure sequences, and resource demands.
The protocol says "perform 12-lead ECG prior to dosing"
The protocol says, "Perform 12-lead ECG prior to dosing at Visits 2, 4, 6, 8, and 10." Ten words. Simple enough on paper.
But here is what those ten words actually mean at your site: someone must read that ECG. If the investigator is the only physician credentialed to interpret ECGs for the study, and the investigator is in clinic on the mornings when dosing visits are scheduled, the ECG cannot happen prior to dosing unless the visit is rescheduled--or unless a qualified sub-investigator is added to the delegation log. The ECG machine itself must be available, calibrated, and not committed to another study's visit at the same time. The ECG paper or digital file must be stored as source data in a format the sponsor has approved. And the window between "prior to dosing" and the actual dose administration must be defined: does "prior to" mean within the same visit day, within one hour, within 30 minutes?