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ACRP CCRC Exam Prep Questions 2023/2024 GRADED A LATEST 2023 What are expected or possible consequences of over-estimation of recruitment potential? - CORRECT ANSWER - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical trial? - CORRECT ANSWER Subject welfare When is the investigator allowed to deviate from the protocol? - CORRECT ANSWER When there is an immediate hazard to a patient. If the investigator wanted to deviate from the protocol for an immediate hazard to a patient, according to ICH E6 guidelines who world they need to report the deviation and rationale to, if appropriate? - CORRECT ANSWER - The Sponsor - IRB/IEC - Regulatory Authorities Which conditions should be fulfilled when enrolling a subject into your trial? - CORRECT ANSWER - Subject meets all inclusion criteria - Subject has given written informed consent You've been delegated to handle the storage and inventory of IP. The study drug must be stored below 25C/77F. On a summer Monday morning you discover that the temperatur