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ACRP CCRA Actual Final Exam Newest / ACRP CCRA
Exam Preparation / ACRP CCRA Practice Exam With
Complete 200 Questions And Correct Detailed
Answers |Already Graded A+(Newest
Version!)||Verified Exam!!!
Regulation Vs. Guidance - Answer-Regulation: has the
effect of laws
Guidance: the current thinking of regulatory bodies;
guidances change and evolve and are non-binding
Purpose for SOPs - Answer-developed by an organization
(site, sponsor, CRO) to provide guidelines to meet
regulations and guidance, as well as promote
organizational consistency
Reasons for the International Conference on
Harmonization (ICH) being convened
-when
-main WHY
-3 main issues - Answer--convened in 1990
-in response to differing regulatory requirements regarding
medicinal products from country to country
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these discrepancies were causing 3 main things:
-rises in costs of drug development
-the repetition of similar studies in diff countries
-the delay in the intro of new medicines
-ICH was created to resolve these issues and unify the
regulatory requirements from country to country
Which 3 countries formed the ICH and when? - Answer--
United States
-European Union
-Japan
1990
When was ICH E6 developed? - Answer-1996
Purpose of ICH E6 - Answer--establish a guideline for
Good Clinical Practice (GCP)
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-ICH E6 serves as the most important guideline for
conducting clinical trials by setting the ethical and scientific
quality standard for designing, conducting, recording, and
reporting in trials that involve humans
What does compliance with GCP mean? - Answer--
compliance with GCP provides: public assurance that the
rights, safety, and well-being of trial subjects are protected
and that the data collected is valid.
-serves as a resource of SOP development, but is not law
in the US (it is in some other countries)
Vulnerable subject - Answer-individual incapable of giving
informed consent or whose voluntary participation in a
study may be influenced by their health, social, economic,
or employment condition
5 examples of vulnerable subjects - Answer-1. students
2. subordinate employees
3. members of the military
4. prisoners
5. patients with incurable disease
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6. person in nursing home
7. unemployed
8. patients in emergency situations
9. ethnic minorities
10. homeless
11. refugees
12. minors
What must an IRB be comprised of? - Answer--at least 5
members
-at least 1 member must have their primary area of
interest as non-scientific
-at least 1 must be independent of the institution/site
-nonmembers may be consulted for expertise but may
NOT participate in the vote
-no IRB may consist entirely of members of one profession
ACRP CCRA Actual Final Exam Newest / ACRP CCRA
Exam Preparation / ACRP CCRA Practice Exam With
Complete 200 Questions And Correct Detailed
Answers |Already Graded A+(Newest
Version!)||Verified Exam!!!
Regulation Vs. Guidance - Answer-Regulation: has the
effect of laws
Guidance: the current thinking of regulatory bodies;
guidances change and evolve and are non-binding
Purpose for SOPs - Answer-developed by an organization
(site, sponsor, CRO) to provide guidelines to meet
regulations and guidance, as well as promote
organizational consistency
Reasons for the International Conference on
Harmonization (ICH) being convened
-when
-main WHY
-3 main issues - Answer--convened in 1990
-in response to differing regulatory requirements regarding
medicinal products from country to country
,2|Page
these discrepancies were causing 3 main things:
-rises in costs of drug development
-the repetition of similar studies in diff countries
-the delay in the intro of new medicines
-ICH was created to resolve these issues and unify the
regulatory requirements from country to country
Which 3 countries formed the ICH and when? - Answer--
United States
-European Union
-Japan
1990
When was ICH E6 developed? - Answer-1996
Purpose of ICH E6 - Answer--establish a guideline for
Good Clinical Practice (GCP)
,3|Page
-ICH E6 serves as the most important guideline for
conducting clinical trials by setting the ethical and scientific
quality standard for designing, conducting, recording, and
reporting in trials that involve humans
What does compliance with GCP mean? - Answer--
compliance with GCP provides: public assurance that the
rights, safety, and well-being of trial subjects are protected
and that the data collected is valid.
-serves as a resource of SOP development, but is not law
in the US (it is in some other countries)
Vulnerable subject - Answer-individual incapable of giving
informed consent or whose voluntary participation in a
study may be influenced by their health, social, economic,
or employment condition
5 examples of vulnerable subjects - Answer-1. students
2. subordinate employees
3. members of the military
4. prisoners
5. patients with incurable disease
, 4|Page
6. person in nursing home
7. unemployed
8. patients in emergency situations
9. ethnic minorities
10. homeless
11. refugees
12. minors
What must an IRB be comprised of? - Answer--at least 5
members
-at least 1 member must have their primary area of
interest as non-scientific
-at least 1 must be independent of the institution/site
-nonmembers may be consulted for expertise but may
NOT participate in the vote
-no IRB may consist entirely of members of one profession
