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ACRP Certified Professional Exam
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A monitor identifies multiple deviations from a protocol-defined timeline for studyprocedures. The monitor is unable to identify proof of PI review and assessment of thedeviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What isthe purpose of this CAPA?
In order to conduct open-label, parallel group clinical trials according to sound scientificprinciples, which of the following design elements should be included?
Who is responsible for submitting a protocol amendment to the IRB/IEC?
Which statement does NOT represent a study monitor's responsibilities?
An investigator participating in a multicenter clinical trial has had 2 of the 4 subjectsadmitted to the emergency room for life-threatening infections. The investigator made thedecision to stop treatment with IP and test for infections in the remaining subjects. Whatare the NEXT steps the investigator should take?
SAEs must be reported immediately by the site to the:
Who determines what criteria and procedures should be followed if a subjectdiscontinues/withdraws their consent?
While consenting a potential subject, a coordinator discovered the subject could not read.Under what conditions can this potential subject be enrolled?
Who determines the age of assent for pediatric studies?
A hospital site is being considered for a trial that requires the IP refrigerator to becontinuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. Thehospital’s Wi-Fi connectivity is inconsistent. During site selection, how should the CRAproceed?