Citi good practice course - Study guides, Class notes & Summaries

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: A. Persons with diminished autonomy should only participate in no more than minimal risk research. B. Persons with diminished autonomy should be excluded from research. C. Persons with diminished autonomy are entitled to protection. D. Persons involved in research cannot financially benefit. - Answer C. Perso...

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...

Which of the following are the three principles included in the Belmont Report? Correct 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? Correct Answer Determining that the study has maximized benefits and minimized risks. Which of the following best describes the principle of informed consent as described in the Belmont Report? Correct Answer Information, comprehen...

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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...

The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Biologics Questions And Complete Answers 2024.

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: Persons with diminished autonomy are entitled to protection. Which of the following are the three principles discussed in the Belmont Report? 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 subject...

RM: CITI Module Quizzes and Answers Already Passed Which of the following are the three principles discussed in the Belmont Report? 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? Determining that the study has a maximization of benefits and a minimization of risks. All of the following are true regarding the Belmont Report, EXCEPT: The Belmont Report indicates tha...

Belmont Report and its principles - Answer 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 a maximization of the benefits and a minimization of risks Which of the following are the three principles discussed in the Belmont Report? - Answer respect for persons, beneficence, justice The Belmont Report's principle of respect for persons incorporates at least two ethi...

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...