Citi gcp training - Study guides, Class notes & Summaries

Citi Training GCP and Refresher

Social/Behavioral Research Training (CITI) Good Clinical Practice (GCP) - correct answer international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects Clinical Trial (NIH Def) - correct answer Beyond just biomedical studies, Social and Behavioral interventions are now defined as clinical trials. Why implement GCP? - correct answer - Protect participants - Prevent non-compliance issues - Y...

Citi Training GCP and Refresher Questions and Answers | Latest Update | 2024/2025 | Already Passed What defines the purpose of phase I research in relation to other phases of research? a. To evaluate the efficacy of a new treatment b. To refine the dosing regimen based on animal testing results c. To assess the safety and tolerability of a new compound d. To determine the maximum tolerated dose How many subjects typically participate in phase I studies? a. 10-20 b. 20-80...

Citi Training GCP and Refresher Review Practice Test 2024. Which of the following defines phase I research as it relates to non-clinical and other phases of research: - CORRECT ANSWER Phase I research is the first phase of research after animal testing and helps define future phase II and III studies. Approximately how many subjects generally participate in phase I studies? - CORRECT ANSWER 20-80 As the amount of adaptive study designs and multiple-arm protocols increases, researchers...

Social Behavioral Research Training (CITI) Question and answers 100% correct 2023/2024 Good Clinical Practice (GCP) - correct answer international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects Clinical Trial (NIH Def) - correct answer Beyond just biomedical studies, Social and Behavioral interventions are now defined as clinical trials. Why implem

CITI TRAINING SET EXAM QUESTIONS WITH COMPLETE SOLUTIONS How is the ICH governed? - Answer-a Steering Committee Who supports the ICH? - Answer-the ICH Secretariat Who provides the ICH secretariat? - Answer-The International Federation of Pharmaceutical Manufacturers Association (IFPMA) How many seats on the Committee does each of the 6 working groups of ICH have? - Answer-2 who nominates other nonvoting participants to attend ICH steering Committee meetings? - Answer-The observer ...

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of A. Institutional vulnerability B. Communicative vulnerability C. Economic vulnerability D. Social vulnerability - CORRECT ANSWER C. Economic vulnerability According to the authors, there are four common abuses that historically are described as giving rise to vulnerability . Which response below contains the correct four? A. Coercion...