GOOD CLINICAL Study guides, Class notes & Summaries

Which of the following are the three principles included in the Belmont Report? - Answer-• Respect for Persons • Beneficence • Justice Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? - Answer-• Determining that the study has maximized benefits and minimized risks. * The Belmont Report's principle of beneficence includes the two general rules as complementary expressions of beneficent actions (1) do not...

Good Clinical Practice Quizzes- SET 1 questions & answers 2023/2024 Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows). a. principal investigator b. sub-investigator c. study coordinator d. coordinating investigator - Ans - b. sub-investigator Any untoward medical occurrence that at any...

QUESTIONS AND ANSWERS

What is Good Clinical Practice (GCP)? - ️️An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects What does Good Clinical Practice assure? - ️️Assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. What is the objec...

Define clinical trials and a basic overview of the types of clinical trials - ANSWER-- Clinical trials (also known as clinical study or clinical research) is a research study using human subjects. - Types of clinical trials: - Observational - Interventional - Retrospective - Prospective - Prevention - Screening - Diagnostic - Treatment - Quality of life · Explain the purpose of clinical trials - ANSWER-- The purpose of clinical trials: - From a scientific perspective, well-conduct...

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows). a. principal investigator b. sub-investigator c. study coordinator d. coordinating investigator - ANSWER-b. sub-investigator Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospit...

A primary purpose of the ICH is to: a. Require FDA registration of worldwide clinical trials. b. Minimize the need for redundant research. c. Require publication of negative trial results. d. Develop mandatory worldwide regulations for drug development. - Answer- b. Minimize the need for redundant research The ICH GCP guidelines: a. Require certification of clinical research sites and investigators b. Set standards for the design, conduct, monitoring and reporting of clinical research. ...

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows). a. principal investigator b. sub-investigator c. study coordinator d. coordinating investigator - Answer- b. sub-investigator Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospi...

Good Clinical Practice ICH questions with correct answers

Good Clinical Practice Quizzes- SET 1 questions with correct answers