Building the reconsent plan: identifying affected participants, prioritizing by visit schedule, and managing the documentation
Teaches RCs to design reconsent plans that identify all affected participants, allocate resources across simultaneous reconsent campaigns, and build the documentation infrastructure that proves completeness to monitors and auditors.
Two studies, 67 participants, two coordinators
The IRB approval letters arrive three days apart. The first approves Amendment 4 to a cardiovascular outcomes study -- a revised safety monitoring schedule that adds echocardiograms at two timepoints for all participants. Forty-five participants are currently enrolled. Reconsent is required for all of them. The second approves Amendment 2 to an immunology study -- a reformulated investigational product that changes the injection volume and site reaction profile. Twenty-two participants are enrolled. Reconsent is required for all of them.
The site has two coordinators available to conduct reconsent conversations. Between the two studies, 67 participants must be reconsented. Some have visits scheduled within the next two weeks. Some are not due back at the site for six weeks. Some have not attended their last two scheduled visits and may be drifting toward withdrawal.
This is not a consent problem. It is a logistics problem. And logistics problems are not solved by dedication or late nights. They are solved by systems: a structured plan that identifies who needs to be reconsented, in what order, by whom, and with what documentation. The previous lesson taught you to determine whether reconsent is required. This lesson teaches you to build the plan that makes it happen -- at portfolio scale, under real-world resource constraints, with documentation that proves completeness months after the last signature is obtained.
What you will learn
By the end of this lesson, you will be able to: