OHRP-aligned decision guide grounded in the 3 required UP criteria.
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
Unanticipated problems are one of the most misunderstood—and over- or under-reported—areas of human subjects research. This one-page Unanticipated Problems Decision Guide translates OHRP’s framework into a practical, step-by-step tool sites can actually use. Instead of re-reading guidance or second-guessing judgment calls, you’ll walk through clear decision questions aligned to each required criterion: -Is the event unexpected? -Is it related or possibly related to the research? -Does it suggest greater risk than previously known? Built to complement ClinIQ Academy’s Unanticipated Problems microsession, this printable helps coordinators, PIs, and QA staff document a defensible assessment—whether an event meets unanticipated problem criteria or not. Perfect for regulatory binders, monitoring visit prep, and 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 and start documenting with confidence.
Add the Unanticipated Problems Decision Guide to your regulatory toolkit today and make every safety assessment clearer, faster, and more defensible.
$5.00