Of those 23, four have visits scheduled within the next week. Six are not due back for another month. Three are between visits with no scheduled contact for eight weeks. Two are remote participants who enrolled during a period of expanded geographic eligibility and live more than 200 miles from the site. One is on a study drug with a narrow therapeutic window and cannot have a gap in dosing while the reconsent is pending. And one -- you know this because the study coordinator mentioned it yesterday -- is considering withdrawal for reasons unrelated to the amendment.

How do you get all of them reconsented? Not eventually. Not when it is convenient. Now, while the trial continues, while participants are taking study drug, while visit windows are opening and closing, while the clock that started when the IRB issued its approval letter keeps running.

This is the operational reality of reconsent. The previous lesson identified which amendments trigger the obligation. This lesson teaches you how to execute it. And I will tell you from decades of watching sites navigate this process: the intellectual challenge of identifying triggers is far simpler than the logistical challenge of completing reconsent across an active roster. Trigger identification is a decision. Reconsent execution is a project -- one with moving parts, competing timelines, and real human beings who have lives outside your study.

Of those 23, four have visits scheduled within the next week. Six are not due back for another month. Three are between visits with no scheduled contact for eight weeks. Two are remote participants who enrolled during a period of expanded geographic eligibility and live more than 200 miles from the site. One is on a study drug with a narrow therapeutic window and cannot have a gap in dosing while the reconsent is pending. And one -- you know this because the study coordinator mentioned it yesterday -- is considering withdrawal for reasons unrelated to the amendment.

How do you get all of them reconsented? Not eventually. Not when it is convenient. Now, while the trial continues, while participants are taking study drug, while visit windows are opening and closing, while the clock that started when the IRB issued its approval letter keeps running.

This is the operational reality of reconsent. The previous lesson identified which amendments trigger the obligation. This lesson teaches you how to execute it. And I will tell you from decades of watching sites navigate this process: the intellectual challenge of identifying triggers is far simpler than the logistical challenge of completing reconsent across an active roster. Trigger identification is a decision. Reconsent execution is a project -- one with moving parts, competing timelines, and real human beings who have lives outside your study.