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CCRP SOCRA Study test in depth Examination and 100% correctly verified Solutions Latest version 2024/2025
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CCRP SOCRA Study test in depth Examination and 100% correctly verified Solutions Latest version 2024/2025 Clinical Safety constitutes what ICH efficacy guidelines? - correct answer E1-E2F Good Clinical Practice constitutes what ICH efficacy guidelines? - correct answer E6 (ICH E6 GCP 1.21)...

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  • November 5, 2024
  • 59
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • ich efficacy guidelines
  • e6 ich e6 gcp 121
  • fda regulations
  • hipaa
  • international committee on harmonization
  • food and drug administration fda
  • ccrp socra study test in depth examination and 100

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  • CCRP SOCRA

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CCRP SOCRA Study test in depth Examination
and 100% correctly verified Solutions Latest
version 2024/2025

Clinical Safety constitutes what ICH efficacy guidelines? -
correct answer E1-E2F


Good Clinical Practice constitutes what ICH efficacy guidelines? -
correct answer E6
(ICH E6 GCP 1.21)


What is the legal status of the International Committee on
Harmonization? - correct answer While several countries have
adopted ICH guidelines as laws, the US FDA adopted ICH only as
guidance. They do not have the force of law in the US and are
not regulations


Compliance is _______, but compliance with ICH is considered
part of __________ - correct answer Voluntary, Good Clinical
Practice


When were FDA regulations first published? - correct answer
1980


When did HHS and FDA revise regulations? - correct answer
1981


When was the Common Rule published? - correct answer 1991

,When did GCP and HIPAA come into play? - correct answer
1996


What is the difference between a law and regulation? - correct
answer A law is passed by legislature and establishes the
authority of a regulatory body. Regulations are passed by
regulatory authorities and have the effect of law, meaning that
there are civil and criminal penalties for noncompliance


Define guidance - correct answer Current thinking of
regulatory bodies


Are guidance documents binding? - correct answer No, they
represent the current thinking on good clinical practices. They
do not create or confer any rights for or on any person and do
not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of
applicable statutes, regulations, or both


Where are FDA regulations published and when? - correct
answer The Code of Federal Regulations is issued annually in
the Federal Register


Decipher the following regulation title:
21 CFR 312.28 (b) - correct answer Title 21 Part 312 Section
28 Paragraph b

,In a regulation title, 21 corresponds to what regulatory
authority? - correct answer Food and Drug Administration
(FDA)


In a regulation title, 45 corresponds to what regulatory
authority? - correct answer Health & Human Services (HHS)


The 300 series of parts apply to... - correct answer Drug
regulations


The 600 series of parts apply to... - correct answer Biologics
regulations


The 800 series of parts apply to.... - correct answer Device
regulations


45 CFR 46 refers to what? - correct answer Protection of
Human Subjects


What does 45 CFR 46 outline? - correct answer Regulations set
forth by the U.S. Department of Health and Human Services.
HHS regulations apply to research involving human subjects
conduced or funded in whole or in part by HHS


21 CFR 50 refers to what - correct answer Protection of Human
Subjects, as set forth by the FDA


21 CFR 56 refers to what - correct answer Institutional Review
Boards, as set forth by the FDA

, FDA regulations apply to all clinical investigations regulated by
the FDA under sections... - correct answer 505(i) and 520(g) of
the Federal Food, Drug, and Cosmetic Act, as well as clinical
investigations that support applications for research or
marketing permits for products regulated by the Food and Drug
Administration, including floods, dietary supplements that bear a
nutrient content claim or a health claim, infant formulas, food
and color additives, drugs for human use, medical devices for
human use, biological products for human use, and electronic
products


45 CFR 46 Subpart A - correct answer Basic HHS Policy for
Protection of Human Research Subjects, also called the Common
Rule. Describes the required protections for all human subjects


45 CFR 46 Subpart B - correct answer Additional protections
for pregnant women, human fetuses, and neonates involved in
research


45 CFR 46 Subpart C - correct answer Additional protections
pertaining to biomedical and behavioral research involving
prisoners as subjects


45 CFR 46 Subpart D - correct answer Additional protections
for children involved as subjects of research


45 CFR 46 Subpart E - correct answer Registration of
Institutional Review Boards

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