ACRP Bootcamp Exam Complete Questions And Answers 2024

ACRP Bootcamp Exam Complete Questions And Answers 2024 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 What is the international conference on harmonization (ICH) guidelines? a. written policies for researchers on how to maintain data on unmarketed investigational products b. a guideline provided by the office for human research protection for subjects enrolling in phase 1 studies c. a unified standard to facilitate the mutual acceptance of clinical data by the regulatory authorities in the european union, japan and the united states d. an international standard for manufacturing, transporting, and storing medicinal products - Answer ️️ -c To be a qualifying clinical trial, which three requirements must be met? a. the trial has therapeutic intent, has an investigational new drug number, and enrolls patients with diagnosed disease b. the trial has therapeutic intent, enrolls patients with diagnosed disease and evaluates an item/service that falls within a medicare benefit category c. the trial has therapeutic intent, has an investigational new drug number, and does not evaluate an item/service that falls within a medicare benefit category d. the trial has an investigational new drug number, does not enroll patients with diagnosed disease and evlauates an item/service that falls within a medicare benefit category - Answer ️️ - b A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate is known as an: a. assent b. informed consent c. subject agreement d. dissent - Answer ️️ -b The primary purpose of the IRB is to ensure a. proper maintenance of the investigation b. to ensure the protection of the rights and welfare of the human subjects d. the information needed to conduct an investigation is