ACRP CCRC CERTIFICATION
CERTIFICATION SCRIPT 2026
QUESTIONS WITH SOLUTIONS
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
◍ 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 was enhanced through the adoption of ICH standards? [2].
Answer: Efficiency and cost-effectiveness of research.
◍ ADR.
Answer: Adverse Drug Reaction
◍ Audit.
Answer: Reviews how the research was conducted; takes into account SOPs,
IRB requirements & GCP (ensures compliance)
◍ 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
,◍ The contents of which underpin the principles of ICH GCP:.
Answer: Declaration of Helsinki
◍ Audit Certificate.
Answer: Confirmation audit took place
◍ Declaration of Helsinki was created by ____ in [YEAR]:.
Answer: Created by the World Medical Association in 1964.
◍ One of the 1st documents to guide physicians and others who conduct
research on ethical principles to be followed:.
Answer: Declaration of Helsinki
◍ Audit Report.
Answer: Written Evaluation - not regularly made available to regulatory
body; only when serious evidence exists concerning non-compliance
◍ Audit Trail.
Answer: Documentation of audit events
◍ Single Blind Study.
Answer: Subjects Unaware
◍ 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.
◍ Double Blind Study.
Answer: Subjects & Researchers are unaware
◍ Which ICH guideline is on Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting?.
Answer: ICH E2A
◍ Comparator.
, Answer: Item used as an active control references in a clinical trail
◍ Which ICH guideline includes: Definitions of adverse events [AE], adverse
drug reactions [ADR], and serious adverse events [SAE]?.
Answer: ICH E2A
◍ Coordinating Committee.
Answer: Group a sponsor comprises to coordinate multi-center trials
◍ Coordinating Investigator.
Answer: An investigator who oversees multiple sites of a clinical trial
(multicenter)
◍ IDMC.
Answer: Independent Data Monitoring Committee, Data & Safety
Monitoring Board (DSMB), Data Monitoring Committee: Oversee safety &
progress; make recommendations to continue, modify or stop
◍ IEC.
Answer: Independent Ethics Committee; group who oversees protection,
rights, safety & well-being of human subjects
◍ Investigator's Brochure.
Answer: Compilation of data on an investigational product used in human
subjects
◍ Legally acceptable representative.
Answer: person whom is lawfully able to consent on behalf of another
◍ Which ICH guideline addresses the concept of expectedness of AEs and the
role of the Investigator's Brochure in determining expectedness of an event?.
Answer: ICH E2A
◍ SAE.
Answer: Serious Adverse Event - Results in death, is life-threatening,
requires long-term hospitalization, results in long term
disability/hospitalization incapacitation or is a congenital birth defect
◍ Source data.
, Answer: original clinical information from source documents (medical
record information)
◍ Which ICH guideline includes reporting timelines for sponsors to notify
regulatory authorities of serious adverse drug reactions?.
Answer: ICH E2A
◍ Which ICH guideline addresses safety definitions and reporting in clinical
trials?.
Answer: ICH E2A
◍ Vulnerable subjects.
Answer: *Hierarchical structure employees*armed
forces*detainees*incurable disease pts*homeless*poor*those in nursing
home*minors*those unable to give consent
◍ Which ICH guideline is also known as the guideline on Good Clinical
Practice [GCP]?.
Answer: ICH E6 [R2]
◍ ICH.
Answer: International Conference on Harmonization
◍ Which ICH guideline details the responsibilities of key parties involved in
clinical trials including the IRB/IEC, investigator, sponsor, and monitor?.
Answer: E6 [R2]
◍ Principles of ICH & GCP.
Answer: *Protect research subjects*conduct research as it has been
approved*research should be clear, organized & approved by an IRB/IEC
◍ IRB / IEC Responsibilities.
Answer: *Oversee principles of ICH/GCP*Make sure the PI / Co-Is are
qualified* Review studies at least once a year
◍ Requirements of an IRB.
Answer: * at least 5 members* one non-scientific member* one
non-institute member
CERTIFICATION SCRIPT 2026
QUESTIONS WITH SOLUTIONS
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
◍ 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 was enhanced through the adoption of ICH standards? [2].
Answer: Efficiency and cost-effectiveness of research.
◍ ADR.
Answer: Adverse Drug Reaction
◍ Audit.
Answer: Reviews how the research was conducted; takes into account SOPs,
IRB requirements & GCP (ensures compliance)
◍ 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
,◍ The contents of which underpin the principles of ICH GCP:.
Answer: Declaration of Helsinki
◍ Audit Certificate.
Answer: Confirmation audit took place
◍ Declaration of Helsinki was created by ____ in [YEAR]:.
Answer: Created by the World Medical Association in 1964.
◍ One of the 1st documents to guide physicians and others who conduct
research on ethical principles to be followed:.
Answer: Declaration of Helsinki
◍ Audit Report.
Answer: Written Evaluation - not regularly made available to regulatory
body; only when serious evidence exists concerning non-compliance
◍ Audit Trail.
Answer: Documentation of audit events
◍ Single Blind Study.
Answer: Subjects Unaware
◍ 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.
◍ Double Blind Study.
Answer: Subjects & Researchers are unaware
◍ Which ICH guideline is on Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting?.
Answer: ICH E2A
◍ Comparator.
, Answer: Item used as an active control references in a clinical trail
◍ Which ICH guideline includes: Definitions of adverse events [AE], adverse
drug reactions [ADR], and serious adverse events [SAE]?.
Answer: ICH E2A
◍ Coordinating Committee.
Answer: Group a sponsor comprises to coordinate multi-center trials
◍ Coordinating Investigator.
Answer: An investigator who oversees multiple sites of a clinical trial
(multicenter)
◍ IDMC.
Answer: Independent Data Monitoring Committee, Data & Safety
Monitoring Board (DSMB), Data Monitoring Committee: Oversee safety &
progress; make recommendations to continue, modify or stop
◍ IEC.
Answer: Independent Ethics Committee; group who oversees protection,
rights, safety & well-being of human subjects
◍ Investigator's Brochure.
Answer: Compilation of data on an investigational product used in human
subjects
◍ Legally acceptable representative.
Answer: person whom is lawfully able to consent on behalf of another
◍ Which ICH guideline addresses the concept of expectedness of AEs and the
role of the Investigator's Brochure in determining expectedness of an event?.
Answer: ICH E2A
◍ SAE.
Answer: Serious Adverse Event - Results in death, is life-threatening,
requires long-term hospitalization, results in long term
disability/hospitalization incapacitation or is a congenital birth defect
◍ Source data.
, Answer: original clinical information from source documents (medical
record information)
◍ Which ICH guideline includes reporting timelines for sponsors to notify
regulatory authorities of serious adverse drug reactions?.
Answer: ICH E2A
◍ Which ICH guideline addresses safety definitions and reporting in clinical
trials?.
Answer: ICH E2A
◍ Vulnerable subjects.
Answer: *Hierarchical structure employees*armed
forces*detainees*incurable disease pts*homeless*poor*those in nursing
home*minors*those unable to give consent
◍ Which ICH guideline is also known as the guideline on Good Clinical
Practice [GCP]?.
Answer: ICH E6 [R2]
◍ ICH.
Answer: International Conference on Harmonization
◍ Which ICH guideline details the responsibilities of key parties involved in
clinical trials including the IRB/IEC, investigator, sponsor, and monitor?.
Answer: E6 [R2]
◍ Principles of ICH & GCP.
Answer: *Protect research subjects*conduct research as it has been
approved*research should be clear, organized & approved by an IRB/IEC
◍ IRB / IEC Responsibilities.
Answer: *Oversee principles of ICH/GCP*Make sure the PI / Co-Is are
qualified* Review studies at least once a year
◍ Requirements of an IRB.
Answer: * at least 5 members* one non-scientific member* one
non-institute member
