Acrp-Cp Exam 2023 Questions And Answers

Non-Inferiority Study {Ans: When the aim of the randomized controlled trial (RCT) is to show that the new treatment is not inferior to an already active treatment that is commonly used for patients of that indication}What do sensitivity analyses test? {Ans: data robustness. -needed to estimate treatment risk and benefits for larger population}IRB/IEC Evaluates {Ans: - The rights, safety, and well-being of the subjects participating in the trial - The subject selection procedure - The scientific tenability of the trial}Minimum SAE reporting requirements {Ans: - Subject details (ID not name) - IP - Interventions for the event that is being reported - Details of the event - Details on the reporter of the event - Admin and sponsor or company details/}All SAE's must be life-threatening to be considered an SAE opposed to AE (T/F) {Ans: True}Parallel {Ans: 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}