Gcp training - Study guides, Class notes & Summaries

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...

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 inve...

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...

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 correct answersa 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 correct answersd Who is ultimately responsible for all aspects of the research conducted at a site? a. IRB b. spons...

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

Good Clinical Practice Quizzes- SET 1 GCP Principle 1 - correct answer 'The rights, safety and wellbeing of the trial subjects shall prevail over the interests of science and society.' GCP Principle 2 (staff) - correct answer 'Each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks.' GCP Principle 3 - correct answer 'Clinical trials shall be scientifically sound and guided by ethical principles.' GCP Principle 4...

Clinical Training Question and answers already passed 2023/2024What is Good Clinical Practice (GCP)? - correct answer A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical studies. GCP guidelines provide a framework for the fair, scientifically sound conduct of research studies involving human participants What is the purpose of the ICH GCP guidelines? - correct answer To ensure that the rights, safety, and confidentiality of par...

Good Clinical Practice (GCP)GCP Principle 1 - correct answer 'The rights, safety and wellbeing of the trial subjects shall prevail over the interests of science and society.' GCP Principle 2 (staff) - correct answer 'Each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks.' GCP Principle 3 - correct answer 'Clinical trials shall be scientifically sound and guided by ethical principles.' GCP Principle 4 - correct ...