CRA ACRP Practice Exam Questions and Answers with explanation

CRA ACRP Practice Exam Questions and Answers with explanation A screening log is useful for determining which of the following? 1. trial reimbursement 2. subject IP compliance 3. active recruitment efforts 4. 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 is A. 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. Any changes to the original planned number of subjects would necessitate an amendment as it affects the statistics linked to the study. While the ICH E6 6.1 states that the sponsor's name and address, etc... are required, a merger does not necessarily mean that there was a change in sponsor name or address, etc... and therefore (D) is incorrect. The guidance also states, "...site specific information may be provided on separate protocol page(s), or addressed in a separate agreement..." which explains why (A) and (B) are not the best answers. After IP has been shipped out to the trial site, the trial monitor discovers that the investigator agreement has not been signed. Which of the following are the BEST courses of action for the CRA to take? 1. Check the site trial binder to ensure that the remainder of the trial documents are in order. 2. Document that there was an oversight in shipping out IP prior to the investigator agreement being signed. 3. Contact the site and ask them to ship back the IP to the CRA.