45 cfr 46 - Study guides, Class notes & Summaries

Good Clinical PracticeWhich 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. * The Belmont Report's principle of beneficence includes the two general rules as complementary express...

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...

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...

UST Test Questions And Answers Latest Updated 2024/2025 (Graded A+) The regulations to enforce compliance of underground storage tank systems in the state are found in? a.) Code of Federal Regulations, 40 CFR Part 281 b.) California Code of Regulations, Title 23, Chapter 16 c.) Code of Federal Regulations, 40 CFR Part 280 d.) California Code of Regulations, Title 23, Chapter 17 - Correct answer b.) California Code of Regulations; Title 23, Chapter 16 2) By definition an "underground stor...

CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, s...

Which of the following was the result of the Beecher article? - Answer- Realization that ethical abuses are not limited to the Nazi regime Issued in 1974, 45 CFR 46 raised to regulatory status: - Answer- US Public Health Service Policy The use of prisoners in research is a concern under the Belmont principle of Justice because: - Answer- Prisoners may not be used to conduct research that only benefits the larger society Which of the following is included in the Nuremberg Code: - Answer-...

Certification for IRB Professionals (CIP) Exam Complete Q&A 2023. According to the Belmont Report, respect for persons usually demands that subjects... According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - A poorly designed protocol is considered unethical because... - When should an IRB suspend or terminate approval of research? - A quorum for a convened IRB meeting requires the pr...

CCRP SOCRA Exam - Practice Exam #1 (Practice Test #1 (Ethics, 21 CFR Parts 50, 56, 312, 812; 45 CFR Part 46) Past questions directly from SOCRA) Passed Qs & As

SOCRA CCRP Exam Questions And Answers April 30 1996 - answer-ICH GCP Development Date Quality - answer-ICH Q Efficacy - answer-ICH E Safety - answer-ICH S Multidisciplinary - answer-ICH M guidance for industry, consolidated guideance - answer-ICH E 6 Clinical Safety Data Management Definitions and Standards - answer-ICH E2A Safety pharmacology studies for human pharmaceuticals - answer-ICH S7A Electronic records, electronic signatures - answer-21 CFR ...

CCRP SOCRA Preparedness baseline Exam knowledge Questions with Expertly written solution 2024/2025 What FDA regulations govern UADE reporting? - correct answer 21 CFR 812 (.15 and .3) What regulations govern research with pregnant women and fetuses? - correct answer 45 CFR 46 Subpart B What requirements must be met to conduct research with pregnant women/fetuses? - correct answer 1) With preclinical and clinical data on non-pregnant women assessing risk to pregnant women 2) Risk to fet...