EXAM FOR ACRP - KEY SKILLS FOR ENSURING QUALITY CONTROL EXAM QUESTIONS AND ANSWERS 100% CORRECT!!

Of the potential risks below, which should be appointed the highest priority to manage in view of patient safety and data quality? - ANSWER Insufficient IP accountability When practicing risk-based decision making in clinical research, what should be the primary focus? - ANSWER Quality of the data Subject safety When assessing the seriousness of a risk, what are the primary considerations that need to be taken into account? - ANSWER The likelihood of occurrence The consequences of the occurrence When assessing the seriousness of a risk, which of the following should the risk be compared to? - ANSWER Standard clinical practice What is essential to keep in mind when determining actions to mitigate potential risks? - ANSWER To make a risk-based decision following a risk management plan Where should potential risks be documented? - ANSWER A risk management plan Which skills are most affected by the introduction of risk-based decision making? - ANSWER Motivational skills Change management What is the most important thing to keep in mind when introducing risk-based decision making into clinical research? - ANSWER The focus of clinical research is on patient safety and quality data Which of the following are objectives of risk-based decision making in clinical trials? - ANSWER Targeting quality control activities to the most vital points to ensure quality data Applying risk avoidance and risk mitigation strategies to avoid endangering subject safety Which of the following statements about risk-based decision making are true? - ANSWER Risk