ACRP CCRC Exam Practice Questions and Answers Latest Updated

What is the goal of a Confirmatory trial? - ANSWER-to provide firm evidence of efficacy or safety What is the goal of an Exploratory trial? - ANSWER-to help provide a basis for confirmatory trials When is a composite variable useful? - ANSWER-when a single variable cannot be selected from multiple measurements What does a global assessment variable measure? - ANSWER-the overall safety, overall efficacy, and/or overall usefulness of a treatment When would multiple primary variables be useful? - ANSWER-to cover a range of effects of therapies When are surrogate variables useful? - ANSWER-when direct assessment of the clinical benefit to the subject through observing actual efficacy is not practical What are ways to avoid bias? - ANSWER-blinding and randomization When would a parallel group design be useful? - ANSWER-when testing different treatments, doses, etc. Why would a crossover design be useful? - ANSWER-it reduces the number of subjects, assessments, etc. What does a factorial design examine? - ANSWER-the interaction between treatments (when treatments are likely to be used together); establishes the dose-response characteristics of the simultaneous use of treatments What are the benefits of a multicenter trial? - ANSWER-they are more efficient and provide a better basis for the subsequent generalization of findings What are superiority trials designed to show? - ANSWER-they establish efficacy What are equivalence or non-inferiority trials designed to show? - ANSWER-that the investigational product is equal or no worse than an active comparator What do dose-response relationship trials show? - ANSWER-they confirm efficacy, investigate the shape and location of the dose-