ACRP Bootcamp Exam Complete Questions And Answers 2023/24

The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers is: a. phase 1 b. phase 2 c. phase 3 d. phase 4 - Answer a Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (IIT) c. Post market device registries d. outcome and health services research - Answer d Who is ultimately responsible for all aspects of the research conducted at a site? a. IRB b. sponsor c. principal investigator d. clinical research coordinator - Answer c What is the definition of good clinical practice (GCP)? a. training provided by sponsors to site staff b. regulations provided by the FDA c. standards developed by european union d. an international quality standard that is provided by ICH - Answer d What event resulted in the Nuremburg Code in 1949? a. thalidomide tragedy b. tuskegee syphilis study c. sulfanilamide Elixir tragedy d. nazi medical experiments - Answer d What is the ICH guideline that is known as the GCP guideline? a. E2A b. E6(R2) c. E11 d. E9 - Answer b Which o the following is not a basic ethical principle according to the Belmont Report? a. vulnerability b. beneficence c. respect for persons d. justice - Answer a This FDA center that regulates blood, vaccines, gene therapy, and tissues is a. BIMO b. CBER c. CDER d. CDRH - Answer b