ACRP CCRA FINAL TEST 2026
QUESTIONS WITH CORRECT
ANSWERS GRADED A+
◍ Cross-sectional study.
Answer: Type of study analyzes data at a specific timepoints rather than
analyzing all data collected over the duration of the study
◍ Case-control study.
Answer: Compares participants who have a particular disease against a
control group of participants who do not have the disease
◍ Cohort study.
Answer: Looks at the enrollment of a set of participants who have a.
particular trait or common characteristic and analyzes their data over a
specific amount of time
◍ ADR.
Answer: Adverse Drug Reaction
◍ Sample.
Answer: section of disease or health population to participate in study
◍ Sample size.
Answer: # of participants needed to answer hypothesis
◍ Audit.
Answer: Reviews how the research was conducted; takes into account SOPs,
IRB requirements & GCP (ensures compliance)
◍ Audit Certificate.
Answer: Confirmation audit took place
◍ Inclusion criteria.
, Answer: List of potential study participants attributes
◍ 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
◍ Exclusion criteria.
Answer: Opposite of inclusion criteria, list of attributes that would prevent
participant from being in the study
◍ Single Blind Study.
Answer: Subjects Unaware
◍ Double Blind Study.
Answer: Subjects & Researchers are unaware
◍ Primary endpoint.
Answer: Variable or result that is most relevant to answer the research
question
◍ Secondary endpoints.
Answer: Additional outcomes monitored to help interpret results of primary
endpoint. Most studies have several
◍ Data.
Answer: values used to assess the primary and secondary endpoints
◍ Comparator.
Answer: Item used as an active control references in a clinical trail
◍ Clinical significance.
Answer: indicates if the trial improves a participant's quality of life
◍ Statistical significance.
Answer: If a studies findings result from the research question under study
or are simply a product of chance. Did the study really work - or was it just
, luck?
◍ Coordinating Committee.
Answer: Group a sponsor comprises to coordinate multi-center trials
◍ Who provides clinical study protocol templates?.
Answer: NIH, FDA, WHO, academic organizations
◍ Who typically develops the protocol?.
Answer: The sponsor
◍ 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
◍ What is one of the most common protocol deviations a CRA tends to
discover?.
Answer: Ineligible participant
◍ IEC.
Answer: Independent Ethics Committee; group who oversees protection,
rights, safety & well-being of human subjects
◍ What is QbD?.
Answer: Quality by design, an approach that outlines how risk-based
monitoring can support a trial
◍ 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
QUESTIONS WITH CORRECT
ANSWERS GRADED A+
◍ Cross-sectional study.
Answer: Type of study analyzes data at a specific timepoints rather than
analyzing all data collected over the duration of the study
◍ Case-control study.
Answer: Compares participants who have a particular disease against a
control group of participants who do not have the disease
◍ Cohort study.
Answer: Looks at the enrollment of a set of participants who have a.
particular trait or common characteristic and analyzes their data over a
specific amount of time
◍ ADR.
Answer: Adverse Drug Reaction
◍ Sample.
Answer: section of disease or health population to participate in study
◍ Sample size.
Answer: # of participants needed to answer hypothesis
◍ Audit.
Answer: Reviews how the research was conducted; takes into account SOPs,
IRB requirements & GCP (ensures compliance)
◍ Audit Certificate.
Answer: Confirmation audit took place
◍ Inclusion criteria.
, Answer: List of potential study participants attributes
◍ 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
◍ Exclusion criteria.
Answer: Opposite of inclusion criteria, list of attributes that would prevent
participant from being in the study
◍ Single Blind Study.
Answer: Subjects Unaware
◍ Double Blind Study.
Answer: Subjects & Researchers are unaware
◍ Primary endpoint.
Answer: Variable or result that is most relevant to answer the research
question
◍ Secondary endpoints.
Answer: Additional outcomes monitored to help interpret results of primary
endpoint. Most studies have several
◍ Data.
Answer: values used to assess the primary and secondary endpoints
◍ Comparator.
Answer: Item used as an active control references in a clinical trail
◍ Clinical significance.
Answer: indicates if the trial improves a participant's quality of life
◍ Statistical significance.
Answer: If a studies findings result from the research question under study
or are simply a product of chance. Did the study really work - or was it just
, luck?
◍ Coordinating Committee.
Answer: Group a sponsor comprises to coordinate multi-center trials
◍ Who provides clinical study protocol templates?.
Answer: NIH, FDA, WHO, academic organizations
◍ Who typically develops the protocol?.
Answer: The sponsor
◍ 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
◍ What is one of the most common protocol deviations a CRA tends to
discover?.
Answer: Ineligible participant
◍ IEC.
Answer: Independent Ethics Committee; group who oversees protection,
rights, safety & well-being of human subjects
◍ What is QbD?.
Answer: Quality by design, an approach that outlines how risk-based
monitoring can support a trial
◍ 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
