ACRP CCRA PRACTICE EXAMINATION
2026 QUESTIONS WITH ANSWERS
GRADED A+
◍ Regulations.
Answer: - 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.
Answer: Japan, USA, EU
◍ What is the primary purpose of Good Clinical Practice (GCP)?.
Answer: Protect the rights, safety, and well-being of trial subjects and ensure
credibility of data.
◍ Why did ICH guidelines develop?.
Answer: To prevent duplication of efforts in 3 countries [Japan, US, EU]
when industry and regulatory authorities collaborated to discuss the need to
advance product registrations.
◍ What takes priority in clinical research?.
Answer: The rights, safety, and well-being of subjects.
◍ What is the ethical foundation document for human subject research?.
Answer: Declaration of Helsinki.
◍ What was enhanced through the adoption of ICH standards? [2].
Answer: Efficiency and cost-effectiveness of research.
◍ The 6 international guidelines that are frequently used as references for
ACRP exams:.
Answer: 1. Declaration of Helsinki2. ICH E2A3. ICH E6 [R2]/GCP4. ICH
, E85. ICH E96. ICH E11
◍ What are the three core ethical principles?.
Answer: Respect for persons; Beneficence; Justice.
◍ The contents of which underpin the principles of ICH GCP:.
Answer: Declaration of Helsinki
◍ What does respect for persons mean?.
Answer: Autonomy and informed consent.
◍ What does beneficence mean?.
Answer: Maximize benefits and minimize harm.
◍ What does justice mean?.
Answer: Fair and equitable subject selection.
◍ Declaration of Helsinki was created by ____ in [YEAR]:.
Answer: Created by the World Medical Association in 1964.
◍ What guideline governs GCP?.
Answer: ICH E6.
◍ One of the 1st documents to guide physicians and others who conduct
research on ethical principles to be followed:.
Answer: Declaration of Helsinki
◍ Main highlights of the Declaration of Helsinki [4]:.
Answer: 1. Importance of informed consent. 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.
◍ Which ICH guideline is on Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting?.
Answer: ICH E2A
◍ Which ICH guideline includes: Definitions of adverse events [AE], adverse
2026 QUESTIONS WITH ANSWERS
GRADED A+
◍ Regulations.
Answer: - 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.
Answer: Japan, USA, EU
◍ What is the primary purpose of Good Clinical Practice (GCP)?.
Answer: Protect the rights, safety, and well-being of trial subjects and ensure
credibility of data.
◍ Why did ICH guidelines develop?.
Answer: To prevent duplication of efforts in 3 countries [Japan, US, EU]
when industry and regulatory authorities collaborated to discuss the need to
advance product registrations.
◍ What takes priority in clinical research?.
Answer: The rights, safety, and well-being of subjects.
◍ What is the ethical foundation document for human subject research?.
Answer: Declaration of Helsinki.
◍ What was enhanced through the adoption of ICH standards? [2].
Answer: Efficiency and cost-effectiveness of research.
◍ The 6 international guidelines that are frequently used as references for
ACRP exams:.
Answer: 1. Declaration of Helsinki2. ICH E2A3. ICH E6 [R2]/GCP4. ICH
, E85. ICH E96. ICH E11
◍ What are the three core ethical principles?.
Answer: Respect for persons; Beneficence; Justice.
◍ The contents of which underpin the principles of ICH GCP:.
Answer: Declaration of Helsinki
◍ What does respect for persons mean?.
Answer: Autonomy and informed consent.
◍ What does beneficence mean?.
Answer: Maximize benefits and minimize harm.
◍ What does justice mean?.
Answer: Fair and equitable subject selection.
◍ Declaration of Helsinki was created by ____ in [YEAR]:.
Answer: Created by the World Medical Association in 1964.
◍ What guideline governs GCP?.
Answer: ICH E6.
◍ One of the 1st documents to guide physicians and others who conduct
research on ethical principles to be followed:.
Answer: Declaration of Helsinki
◍ Main highlights of the Declaration of Helsinki [4]:.
Answer: 1. Importance of informed consent. 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.
◍ Which ICH guideline is on Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting?.
Answer: ICH E2A
◍ Which ICH guideline includes: Definitions of adverse events [AE], adverse
