Irb - Study guides, Class notes & Summaries

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ACRP Practice Exam Questions and Correct Answers 100% Verified 2024/2025
  • ACRP Practice Exam Questions and Correct Answers 100% Verified 2024/2025

  • Exam (elaborations) • 19 pages • 2024
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  • ACRP Practice Exam Questions and Correct Answers 100% Verified 2024/2025 A research study, in which there is no intended clinical benefit to the subject, is being submitted to the IRB/IEC. What benefit information should be included in the ICF? a. The benefits section should be left out of the ICF, as it is not applicable. b. Wording indicating that there is no expected benefit should be included. c. A section on the benefits of clinical research in general should be added. d. A descrip...
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CIP Exam Questions With 100% Correct Answers.
  • CIP Exam Questions With 100% Correct Answers.

  • Exam (elaborations) • 25 pages • 2023
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  • Minimal Risk - The probability of harm or discomfort...not greater...than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations. The Belmont Principles -Respect for persons, beneficence, and justice IRB - An administrative body composed of scientists and nonscientists established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the inst...
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Certification for IRB Professionals (CIP) Exam Complete Questions & Answers
  • Certification for IRB Professionals (CIP) Exam Complete Questions & Answers

  • Exam (elaborations) • 5 pages • 2023
  • Certification for IRB Professionals (CIP) Exam Complete Questions & Answers-According to the Belmont Report, respect for persons usually demands that subjects... - enter into research voluntarily & with adequate information According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - Justice A poorly designed protocol is considered unethical because... - research subjects may be put at risk or inconv...
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SOCRA EXAM PREP | 2023/ 2024 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide
  • SOCRA EXAM PREP | 2023/ 2024 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide

  • Exam (elaborations) • 356 pages • 2023
  • SOCRA EXAM PREP | 2023 Update | Questions and Verified Answers| Highly Rated Guide Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? Answer: 1) Progress of investigations under IND 2) Secure compliance or discontinue investigators that are not compliant and notify FDA 3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 4) Notify FDA, all IRBs and all investigators if drug presen...
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CITI Training - Good Clinical Practice correctly answered 2023/2024
  • CITI Training - Good Clinical Practice correctly answered 2023/2024

  • Exam (elaborations) • 7 pages • 2024 Popular
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  • CITI Training - Good Clinical Practice Good Clinical Practice Course for Clinical Trials with Investigational Drugs and Medical Devices - correct answer 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 min...
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Frontier Airlines Oral Exam Guide (Frontier Airlines Oral Exam Guide Airbus A319 A320 A321)
  • Frontier Airlines Oral Exam Guide (Frontier Airlines Oral Exam Guide Airbus A319 A320 A321)

  • Exam (elaborations) • 19 pages • 2023
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  • Frontier Airlines Oral Exam Guide (Frontier Airlines Oral Exam Guide Airbus A319 A320 A321)
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Frontier Airlines Airbus Oral Prep (PT/PC) exam questions with verified correct answers
  • Frontier Airlines Airbus Oral Prep (PT/PC) exam questions with verified correct answers

  • Exam (elaborations) • 69 pages • 2023
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  • Explain Captain/Dispatcher joint responsibility. - correct answer ...for the preflight planning of each flight. They determine the suitability of weather, field, traffic and airways. Either can delay a flight, but only SOC (Systems Operations Control) can cancel a flight. When is an alternate required? - correct answer --The 123 rule: within 1 hr of arrival: 2,000 ft ceiling and 3 sm vis (for domestic operations) --123+ 1 hr: 2,000ft or 1500 above the lowest IAP mins whichever is higher,...
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CCRP SoCRA Exam Latest Update Rated A
  • CCRP SoCRA Exam Latest Update Rated A

  • Exam (elaborations) • 12 pages • 2024
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  • CCRP SoCRA Exam Latest Update Rated A 21 CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B Electronic Records 21 CFR Part 11 Subpart C Electronic Signatures 21 CFR Part 50 Protection of Human Subjects 21 CFR Part 50 Subpart B Informed Consent of Human Subjects 21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 21 CFR Part 56 Institutional Review Board 21 CFR Part 56 Subpart B Organization and Personnel 21 CFR Part 56 Subpa...
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