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CITI Training questions with correct answers

What must you file before conducting human clinical trials with an experimental drug? - Answer IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? - Answer Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant changes in investigators conducting clinical trials under the IN...

CITI Training questions with correct answers

CITI TRAINING QUIZ 2023-2024 ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS||AGRADE

Three principles of Belmont Report - Answer Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence - Answer MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - Answer TRUE The Belmont Report Respect for Person - Answer Requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed...

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...

CITI training questions with correct answers

1. Which of the following are the three principles discussed in the Belmont Report? - Answer Respect for Persons, Beneficence, Justice 2. The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - Answer Persons with diminished autonomy are entitled to protection. 3. Which of the following is an example of how the principle of beneficence can be applied to a st...

Citi Training QUESTIONS & ANSWERS 2023 ( A+ GRADED 100% VERIFIED)

CITI Training questions with correct answers