A subject has creatinine 1.

SOCRA CCRP Question Answer

A subject has creatinine 1.6 mg/dL, slightly above eligibility (≤1.5). Investigator believes this is normal for size. When can subject be enrolled?

After sponsor revises eligibility and IRB approves amendment

After repeat test confirms 1.6

After monitor approves deviation

After investigator documents explanation in chart

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