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ACRP- Clinical Research Knowledge Assessment (CRKA) Latest Exam with Questions and Verified Answers 2025 True or false? Direct communication between a sponsor and IRB/IEC is expressly prohibited per GCP. - Correct Answer False As part of their risk assessment process the sponsor determines that there is a high likelihood that enrollment in the trial will be challenging and slow. Which of the following is the best choice in this situation: a. The sponsor should develop a risk management plan to handle this operational risk b. The sponsor should develop a proactive recruitment strategy to mitigate the risk of low enrollment c. The sponsor should outsource the trial to a CRO to ensure enrollment success d. All of the above e. A and B only - Correct Answer e) A &B Only In considering whether or not to approve a clinical trial, the IRB/IEC should consider the qualifications of the investigator via review of a current curriculum vitae or other documentation. a. True
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