Built on OHRP's three required criteria for an unanticipated problem.
Yes/No decision questions that support clear documentation and rationale.
Single-page, binder-ready format for real-world site use.
Binder-Ready Unanticipated Problems Decision Guide.
Most sites land in one of two ditches with unanticipated problems: reporting things that don't qualify, or missing the ones that do. This one-page guide keeps you out of both. It turns the OHRP framework into plain decision questions you walk through and document, instead of re-reading guidance or second-guessing a judgment call. You'll work through each required criterion in order: - Is the event unexpected? - Is it related, or possibly related, to the research? - Does it suggest greater risk than you knew about before? Built to go alongside ClinIQ Academy's Unanticipated Problems session, it helps coordinators, PIs, and QA staff document a decision they can defend, whether or not the event turns out to be a UP. Keep it in your regulatory binder, your monitoring-visit prep, and your day-to-day safety reviews. Licensed for individual or single-site use. Full licensing details can be found at catalog.cliniq.academy/pages/license-agreement.
Stop guessing. Start documenting.
Add the decision guide to your regulatory toolkit and make every UP assessment clearer, faster, and easier to defend.
$5.00