Acrp Ccrc Exam Question With Complete Solution 2023

A recruitment plan was developed by the research site for a new drug trial that involves enrollment of population between the ages of 6-10 years old. Which of the following activities should the CRA consider when reviewing the site's plan? {Ans: 1. Verify that the IRB/IEC has reviewed the plan. 2. Verify that the IRB/IEC has approved the plan. 3. Ensure the ICF includes assent and consent. 4. Ensure the IRB/IEC requirements for assent are met. A. 1 and 3 only B. 1 and 4 only C. 2 and 3 only D. 2 and 4 only (D)}(DoH) The _________________________________ must be independent of the investigator, the sponsor or any other kind of undue influence. {Ans: Institutional Review Board/Committee}According to the ICH-E2A, what is the initial reporting timeline required by the sponsor for fatal or life-threatening unexpected ADR's (adverse drug reaction)? {Ans: ≤ 7 calendar days. "As soon as possible, but no later than 7 calendar days after first knowledge by the sponsor."}A trial protocol amendment is required if there is {Ans: A. a replacement of a site. B. a site investigator change. C. an increase in the sample size. D. a merger involving the sponsor. (C)}A