Citi study 2 questions Study guides, Class notes & Summaries

CITI Training Quiz Questions with 100% Correct Answers 1. Which of the following are the three principles discussed in the Belmont Report? - Correct 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: - Correct Answer ️️ -Persons with diminished autonomy are entitled to protection. 3. Which of the...

CITI Training 134 Questions With Complete Solutions Latest Update Score A+. What must you file before conducting human clinical trials with an experimental drug? Correct Answer: IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct 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 n...

CITI Training Questions with 100% Correct Answers . Three principles of Belmont Report - Correct Answer; Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence - Correct Answer; MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - Correct Answer; TRUE The Belmont Report Respect for Person - Correct Answer; Requires that subjects freely choose to participate in research ...

CITI Training Exam Questions and Answers 100% Correct Three principles of Belmont Report - Correct Answer ️️ -Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence - Correct Answer ️️ -MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - Correct Answer ️️ -TRUE The Belmont Report Respect for Person - Correct Answer ️️ -Requires that subjects freely choos...

CITI Training 134 Questions With Complete Solutions Latest Updated 2024 (GRADED A+) What must you file before conducting human clinical trials with an experimental drug? Correct Answer: IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct 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 doc...

CITI Training Exam Questions With Complete Solutions Latest Update (Score A+). What is the timeline of drug development? Correct Answer: Preclinical trials, IND Submission, Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV) When does a sponsor submit the IND? Correct Answer: Prior to clinical development phases (human trials). *30 day process. What is the NDA? Correct Answer: New Drug Application, submitted prior to Phase IV marketing phase. How long does the NDA su...

CITI Training, Questions with accurate answers, 100% verified. Rated A Belmont Report and its principles - 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 the benefits and a minimization of risks Which of the following are the three principles discussed in the Belmont Report? - respect for persons, beneficence, justice The Belmont Report's principle of...

CITI Training, Modules 1-24 (Biomedical Research) Questions and Answers 2023/2024 Score A+. 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 ...

CITI GCP Training Questions and Answers Graded A+ ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. ICH (2016) E6 Section 4.8.10(n) states that the informed consent should indicate ...

CITI Training, Modules 1-24 Exam Questions With Answers Latest Updated 2024 (GRADED) 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 prot...