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Table 4 Unanticipated problem reporting (per UAMS IRB policy at time of approval of this protocol)

From: Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial

Unanticipated problem

Required reporting time to cIRB

Death or life-threatening

Immediately to IRB office or IRB Chair

All other events

Within 10 days of event or notification of event if non-local

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Trials

ISSN: 1745-6215