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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 accordance with the CFR, for at least how many years after the completion of a study must the clinical investigator provide the sponsor with relevant changes to financial information?
An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety. Which of the following parties, if any, is the investigator required to noti
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?
In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?
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