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?
For an investigational new drug study that has potential side effects of myalgia, arthralgia, and lethargy, which of the following could serve as an acceptable consent statement?
In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:
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