ACRP - CCRC Exam Prep - CC Exam
Questions and Answers with Verified
Solutions | Latest Updated 2026
Regulation Vs. Guidance Regulation: has the effect of laws
Guidance: the current thinking of
regulatory bodies; guidances change
and evolve and are non-binding
Purpose for SOPs 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 -convened in 1990
Conference on Harmonization
(ICH) being convened-when - in response to differing regulatory
requirements regarding medicinal
- main WHY products from country to country
these discrepancies were causing 3
- 3 main issues 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 -United States-European
ICH and when? Union-Japan 1990
When was ICH E6 developed? 1996
Purpose of ICH E6 -establish a guideline for Good
Clinical Practice (GCP)
- 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 -compliance with GCP provides:
GCP mean? 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 individual incapable of giving
informed consent or whose
voluntary participation in a study
may be influenced by their health,
social, economic, or employment
condition
Questions and Answers with Verified
Solutions | Latest Updated 2026
Regulation Vs. Guidance Regulation: has the effect of laws
Guidance: the current thinking of
regulatory bodies; guidances change
and evolve and are non-binding
Purpose for SOPs 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 -convened in 1990
Conference on Harmonization
(ICH) being convened-when - in response to differing regulatory
requirements regarding medicinal
- main WHY products from country to country
these discrepancies were causing 3
- 3 main issues 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 -United States-European
ICH and when? Union-Japan 1990
When was ICH E6 developed? 1996
Purpose of ICH E6 -establish a guideline for Good
Clinical Practice (GCP)
- 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 -compliance with GCP provides:
GCP mean? 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 individual incapable of giving
informed consent or whose
voluntary participation in a study
may be influenced by their health,
social, economic, or employment
condition
