Cra Acrp Practice Exam (Latest 2023 2024) Questions And Answers With Explanations

CRA ACRP Practice Exam (Latest 2023 – 2024) Questions and Answers With ExplanationsA screening log is useful for determining which of the following?1. trial reimbursement2. subject IP compliance3. active recruitment efforts4. trends regarding evaluable subjects - 1 and 3 only.E6 8.3.20 A screening log will provide evidence of an investigator's efforts to recruit subjects even if they are unable to identify subjects that meet entry criteria, which can help discriminate sites who are failing to make an effort to recruit from sites who have been unable to enroll subjects despite substantial efforts to do so. In addition, site contracts routinely contain provisions that allow for payment for some or all of the screen failures evaluated at the site, even if these subjects are not enrolled. Information on subject IP compliance and evaluability is captured elsewhere and would not appear on the screening log.A trial protocol amendment is required if there isA. a replacement of a site.B. a site investigator change.C. an increase in the sample size.D. a merger involving the sponsor. - an increase in the sample size.As per ICH E6 6.9.2, the number of subjects planned to be enrolled is a key component of protocols and amendments.