ACRP-CP Exam 100% Correct

Crossover - ANSWER when each subject is randomized to a sequence of two or more treatments and hence acts as their own control for treatment comparisons Parallel - ANSWER when subjects are randomized to 1 of 2 or more arms, each arm being allocated a different treatment. Each treatment will include their investigational product at one or more doses, and one or more control treatments, such as placebo and/or an active comparator A sponsor is developing an IP for treatment of a medical condition where there is one additional marketed product approved for treatment of the condition. The sponsor believes their product works as well or better than the current treatment with fewer side effects. What is the most-likely study design they will use to test the efficacy of the IP? - ANSWER Non-Inferiority What type of clinical trial most likely requires enrollment of the largest number of research subjects? - ANSWER Therapeutic confirmatory (aka Pivotal Trial, Ph III, or Comparative Efficacy) Minimum number of membors on an IRB/IEC - ANSWER 5 .. lay people and medical professionals can be part of the IRB/IEC Who is responsible for providing the protocol - ANSWER The Sponsor The purpose of the SIV is to - ANSWER -review standard procedures -review the protocol