Irb - Study guides, Class notes & Summaries
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IRB Test Questions with 100% Correct Answers | Latest Version 2024 | Verified
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The Belmont principle of beneficence requires that: 
A. Subjects derive individual benefit from study participation. 
B. Potential benefits justify the risks of harm. 
C. The study makes a significant contribution to generalizable knowledge. 
D. Risks are managed so that they are no more than minimal. - B. Potential benefits justify the risks 
of harm. 
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of 
research subjects, expresses the princip...
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CITI Training, Modules 1-24 (Biomedical Research) Questions and Answers (2023/2024) With Complete Solution.
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CITI Training, Modules 1-24 (Biomedical Research) Questions and Answers (2023/2024) With Complete Solution. 
1. 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 au...
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NAPSR/CNPR Exam 2023 with 100% correct answers
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Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. 
True 
 
 
 
Average review time for a new drug 
18 months 
 
 
 
Sales Team 
Pg 7 
 
 
 
The "engine of innovation," focused on discovering or inventing promising new product. 
Research & Development 
 
 
 
This includes supply chain, manufacturing, trade, and distribution functions of the business. 
Manufacturing & Operations 
 
 
 
In 2012, FDA r...
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CCRP Exam Questions Bank | 273 Questions with 100% Correct Answers
- Exam (elaborations) • 31 pages • 2022
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How many days does a sponsor have to report an emergency use of an IP to the FDA? 
- 5 working days 
How many members must sit on an IRB? - 5 
How long must an IRB retain records per 21 CFR 56? - 3 years after completion of 
research 
What are the criteria for IRB approval of research? (7) - 1. Risks to subjects are 
minimized 
2. Risks are reasonable in relation to anticipated benefits 
3. Selection of subjects is equitable 
4. Informed consent will be sought from subjects or LARs 
5. Informed ...
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IRB Test Exam Questions And Answers (Verified And Updated)
- Exam (elaborations) • 27 pages • 2024
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IRB Test Exam Questions And Answers 
(Verified And Updated) 
The Belmont principle of beneficence requires that: 
A. Subjects derive individual benefit from study participation. 
B. Potential benefits justify the risks of harm. 
C. The study makes a significant contribution to generalizable knowledge. 
D. Risks are managed so that they are no more than minimal. - answerB. Potential benefits 
justify the risks of harm. 
According to the Belmont Report, the moral requirement that there be fair out...
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IRB TEST QUESTIONS WITH COMPLETE SOLUTIONS.
- Exam (elaborations) • 19 pages • 2024
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IRB TEST QUESTIONS WITH COMPLETE SOLUTIONS.
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IRB Test Questions with 100% Correct Answers | Latest Version 2024 | Verified
- Exam (elaborations) • 27 pages • 2024
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IRB Test Questions with 100% Correct 
Answers | Latest Version 2024 | Verified
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ACRP Practice Exam 2023 Questions and Answers
- Exam (elaborations) • 8 pages • 2023
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A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - ANSWER 50% 
 
To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and rental function tests no greater than three times the upper limit normal. All of the following are normal ranges for the trial: 
AST 5-65 ALT 5-35 BUN 4-25 
Creat 0.5-1.2...
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IRB Test Questions with 100% Correct Answers | Latest Version 2024 | Verified
- Exam (elaborations) • 27 pages • 2024
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IRB Test Questions with 100% Correct 
Answers | Latest Version 2024 | Verified 
The Belmont principle of beneficence requires that: 
 
A. Subjects derive individual benefit from study participation. 
B. Potential benefits justify the risks of harm. 
C. The study makes a significant contribution to generalizable knowledge. 
D. Risks are managed so that they are no more than minimal. - B. Potential benefits justify the risks 
of harm. 
 
According to the Belmont Report, the moral requirement that ...
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CITI -Social Behavioral Research Questions and Answers
- Exam (elaborations) • 9 pages • 2023
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CITI -Social Behavioral Research Questions and Answers 
 What procedures must be described in an agreement called an "assurance of compliance" with OHRP? 
Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. 
 
 
 
A researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional policy. Accordi...
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