Irb practice test - Study guides, Class notes & Summaries
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CCRP Practice Questions | 100% Correct Answers | Verified | Latest 2024 Version
- Exam (elaborations) • 13 pages • 2024
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CCRP Practice Questions | 100% Correct 
Answers | Verified | Latest 2024 Version 
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of 
the: - PI and Sponsor. 
 
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - The 
subject's legally acceptable representative 
 
Which of the following required elements should be included in a clinical trial protocol? - The subject 
inclusion and exclusion c...
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CCRP Final Exam Study Guide Practice Questions.
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CCRP Final Exam Study Guide Practice Questions. 
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - correct answer PI and Sponsor. 
 
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - correct answer The subject's legally acceptable representative 
 
Which of the following required elements should be included in a clinical trial protocol? - correct answer The subject inclusion and e...
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N580 Midterm Exam Questions with 100% Correct Answers
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Nurses on the cutting edge Correct Answer promote improvement in patient outcomes 
Accomplish this through: research, EBP, and QI 
 
Nurses achieve personal growth through and expand clinical decision-making skills through... Correct Answer development of clinical questions 
Literature reviews 
Evaluation of evidence in literature 
Application of "best available evidence" in your practice 
 
Nurses as knowledgable consumers Correct Answer nurses must be knowledgable consumers of research who c...
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 
 
Clinical Trial 
process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. 
Endpoint or Outcome 
Clinical event, measurable indicator, subject reported response 
Brainpower 
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Feasibility of a Study 
Assessment of resource needs, regulator requirements, and potential level of risk of ha...
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2023 US RAC Practice Exam Questions With Correct Explanations
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2023 US RAC Practice Exam Questions With Correct Explanations 
A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment 
with an approved device. This side effect is not listed in the package insert. This event must be reported 
by the manufacturer to FDA no later than: 
A. 5 calendar days. 
B. 15 calendar days. 
C. 30 calendar days. 
D. The next quarterly or annual report. -Explanation: 
B. There are no 15 day reports included in MDR regulations....
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Good Clinical Practice Test Questions and Answers Latest Updated
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Good Clinical Practice Test Questions and Answers Latest Updated 
Which of the following are the three principles included 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 maximized benefits and minimized risks. 
 
* The Belmont Report's principle of beneficence includes the two general rules as compl...
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ACRP Practice Test questions with correct answers
- Exam (elaborations) • 6 pages • 2024
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ACRP Practice Test questions with correct answers 
What are the liver function tests? (LFT) - Correct Answers Liver function tests (also known as a liver panel) are blood tests that measure different enzymes, proteins, and other substances made by the liver. 
* Albumin, a protein made in the liver 
* Total protein, This test measures the total amount of protein in the blood. 
* ALP (alkaline phosphatase), ALT (alanine transaminase), AST (aspartate aminotransferase), and gamma-glutamyl transpepti...
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CITI GCP Training Study Guide Test.
- Exam (elaborations) • 22 pages • 2024
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CITI GCP Training Study Guide Test. 
 
 
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 that "the...
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Good Clinical Practice (GCP) well answered
- Exam (elaborations) • 6 pages • 2024
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Good Clinical Practice (GCP) 
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 Respect for Persons as described in the Belmont Report? -...
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RAC Practice Exam 1 Questions and Answers New Version 2024 Complete
- Exam (elaborations) • 22 pages • 2024
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RAC Practice Exam 1 Questions and Answers 
New Version 2024 Complete 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic 
records and electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries 
and actions that create, modify or delete electronic records. 
B Validation of systems to ensure accuracy 
C Authority checks to ensure that only authorized personell can create, modify or delete 
electronic re...
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