CCRC Module 2: Overview of ACRP
Certification Exam Questions and
Answers with Verified Solutions | Latest
Updated 2026
Regulations - are issued by regulatory authorities
such as the FDA, or European
Medicines Agency [EMA]
- applicable only in the country or
countries within the jurisdiction of
these authorities (e.g. FDA = USA,
EMA = Europe)
The 3 primary ICH regions Japan, USA, EU
Why did ICH guidelines To prevent duplication of efforts in 3
develop? countries [Japan, US, EU] when
industry and regulatory authorities
collaborated to discuss the need to
advance product registrations.
What was enhanced through Efficiency and cost-effectiveness of
the adoption of ICH standards? research.
[2]
The 6 international guidelines 1. Declaration of Helsinki
that are frequently used as
references for ACRP exams: 2. ICH E2A
, 3. ICH E6 [R2]/GCP
4. ICH E8
5. ICH E9
6. ICH E11
The contents of which Declaration of Helsinki
underpin the principles of ICH
GCP:
Declaration of Helsinki was Created by the World Medical
created by ____ in [YEAR]: Association in 1964.
One of the 1st documents to Declaration of Helsinki
guide physicians and others
who conduct research on
ethical principles to be
followed:
Main highlights of the 1. Importance of informed consent.
Declaration of Helsinki [4]:
2. Requirement of ethical review and
approval of research before it is
undertaken.
3. Acknowledgement and guidance
of special protections for vulnerable
subjects.
4. Recommendation that clinical
trials are registered on public
databases.
Certification Exam Questions and
Answers with Verified Solutions | Latest
Updated 2026
Regulations - are issued by regulatory authorities
such as the FDA, or European
Medicines Agency [EMA]
- applicable only in the country or
countries within the jurisdiction of
these authorities (e.g. FDA = USA,
EMA = Europe)
The 3 primary ICH regions Japan, USA, EU
Why did ICH guidelines To prevent duplication of efforts in 3
develop? countries [Japan, US, EU] when
industry and regulatory authorities
collaborated to discuss the need to
advance product registrations.
What was enhanced through Efficiency and cost-effectiveness of
the adoption of ICH standards? research.
[2]
The 6 international guidelines 1. Declaration of Helsinki
that are frequently used as
references for ACRP exams: 2. ICH E2A
, 3. ICH E6 [R2]/GCP
4. ICH E8
5. ICH E9
6. ICH E11
The contents of which Declaration of Helsinki
underpin the principles of ICH
GCP:
Declaration of Helsinki was Created by the World Medical
created by ____ in [YEAR]: Association in 1964.
One of the 1st documents to Declaration of Helsinki
guide physicians and others
who conduct research on
ethical principles to be
followed:
Main highlights of the 1. Importance of informed consent.
Declaration of Helsinki [4]:
2. Requirement of ethical review and
approval of research before it is
undertaken.
3. Acknowledgement and guidance
of special protections for vulnerable
subjects.
4. Recommendation that clinical
trials are registered on public
databases.
