A sponsor conducts a centralized statistical monitoring (CSM) review and identifies Site B as having an unusually low rate of adverse event reporting compared to similar sites. What is the most appropriate interpretation?
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A
Site B has the best-performing subjects in the trial
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B
Site B may have an underreporting issue that warrants targeted on-site investigation
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C
CSM results are unreliable and should be disregarded
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D
The site should be closed immediately without further review