ACRP CCRC LATEST 2026 COMPREHENSIVE EXAM
QUESTIONS AND ANSWERS GRADED A+
✔✔What is the "Per Protocol" Set? - ✔✔A subset of participants who adhered to the
protocol and had no major PDs. These are the patients who would be likely to exhibit
treatment effects.
✔✔What are the other three possible names for the "Per Protocol" Set? - ✔✔Evaluable
subjects, valid cases, and efficacy sample.
✔✔What is a type I error? - ✔✔False Positive
✔✔What is a type II error? - ✔✔False negative
✔✔Why are missing values crucial? - ✔✔They represent a potential source of bias.
✔✔Treatment Emergent Concept - ✔✔AEs are only recorded if they emerge or worsen
relative to the patient's pre-treatment baseline (may be used in psychiatry studies, for
example).
✔✔What are other methods of treatment emergent concept? - ✔✔Only reporting events
if they occur at multiple visits and not reporting mild AEs.
✔✔Blind Review - ✔✔The period of time between trial completion (which is the last visit
of the last subject) and breaking the blind for analysis purposes.
✔✔Qualitative Interaction - ✔✔Refers to interactions where the direction of the main
effect may completely change.
✔✔Quantitative Interaction - ✔✔Refers to interactions where the main effect may be
amplified or diminished, but the overall direction of the effect doesn't change.
✔✔Inter-rater reliability - ✔✔Looks at how consistent measurements are across several
people.
✔✔Intra-rater reliability - ✔✔Looks at how consistent measurements are from a single
person.
✔✔What is the IQRMP? - ✔✔Integrated Quality Risk Management Plan. This outlines
the strategy to identify, assess, and manage risks.
✔✔What is tachyphylaxis? - ✔✔Rapid decrease in drug effectiveness (differs from
tolerance- tolerance is a gradual decrease in drug effectiveness over time requiring
larger doses to achieve same effect)
, ✔✔What does AEFI stand for? - ✔✔Adverse event following immunizations
✔✔What is Vigibase? - ✔✔The WHO global database of reported ADRs
✔✔Within how many days must UAPs be reported to the IRB? - ✔✔10 working days
✔✔AEs and SAEs may still be reported until how many days after a subject concludes a
study? - ✔✔30 days post-treatment
✔✔What is BIMO? - ✔✔FDA Bioresearch Monitoring program. Conducts inspections
and data audits to ensure human subject protection.
✔✔What does VAI mean? - ✔✔Voluntary Action Indicated. Grievances may be found
during an inspection, but if the regulatory agency believes the facility can correct the
issues voluntarily, then they will list VAI without formal action taken.
✔✔Within how many hours does an antibody-dependent cellular cytotoxicity reaction
typically occur? - ✔✔5-12 hours
✔✔What is a type A drug reaction? - ✔✔These are augmented reactions, they are
"dose-dependent" and have predictable pharmacology. (A=Augmented)
✔✔What is a type B drug reaction? - ✔✔These are bizarre reactions that are
idiosyncratic in nature and not predictable based on their pharmacology, "dose-
independent". (B=bizarre)
✔✔What topic does ICH E2a cover? (Generally) - ✔✔Expedited Reporting
✔✔What topic does ICH E8 cover? (Generally) - ✔✔General considerations for clinical
trials
✔✔Non-therapeutic Trial - ✔✔Trial without any expected therapeutic benefit (typically
conducted in patients with the disease)
✔✔What are the primary purposes of monitoring visits? - ✔✔Ensure the site is GCP
compliant, data is ALCOA, and patient's rights are respected.
✔✔What are "stopping rules"? - ✔✔Discontinuation Criteria
✔✔What are "Critical to quality" factors? - ✔✔Data essential for trial reliability
✔✔What are platform studies? - ✔✔Studies that allow for multiple drugs to enter/leave
the study in a continuous manner based on pre-specified rules.
QUESTIONS AND ANSWERS GRADED A+
✔✔What is the "Per Protocol" Set? - ✔✔A subset of participants who adhered to the
protocol and had no major PDs. These are the patients who would be likely to exhibit
treatment effects.
✔✔What are the other three possible names for the "Per Protocol" Set? - ✔✔Evaluable
subjects, valid cases, and efficacy sample.
✔✔What is a type I error? - ✔✔False Positive
✔✔What is a type II error? - ✔✔False negative
✔✔Why are missing values crucial? - ✔✔They represent a potential source of bias.
✔✔Treatment Emergent Concept - ✔✔AEs are only recorded if they emerge or worsen
relative to the patient's pre-treatment baseline (may be used in psychiatry studies, for
example).
✔✔What are other methods of treatment emergent concept? - ✔✔Only reporting events
if they occur at multiple visits and not reporting mild AEs.
✔✔Blind Review - ✔✔The period of time between trial completion (which is the last visit
of the last subject) and breaking the blind for analysis purposes.
✔✔Qualitative Interaction - ✔✔Refers to interactions where the direction of the main
effect may completely change.
✔✔Quantitative Interaction - ✔✔Refers to interactions where the main effect may be
amplified or diminished, but the overall direction of the effect doesn't change.
✔✔Inter-rater reliability - ✔✔Looks at how consistent measurements are across several
people.
✔✔Intra-rater reliability - ✔✔Looks at how consistent measurements are from a single
person.
✔✔What is the IQRMP? - ✔✔Integrated Quality Risk Management Plan. This outlines
the strategy to identify, assess, and manage risks.
✔✔What is tachyphylaxis? - ✔✔Rapid decrease in drug effectiveness (differs from
tolerance- tolerance is a gradual decrease in drug effectiveness over time requiring
larger doses to achieve same effect)
, ✔✔What does AEFI stand for? - ✔✔Adverse event following immunizations
✔✔What is Vigibase? - ✔✔The WHO global database of reported ADRs
✔✔Within how many days must UAPs be reported to the IRB? - ✔✔10 working days
✔✔AEs and SAEs may still be reported until how many days after a subject concludes a
study? - ✔✔30 days post-treatment
✔✔What is BIMO? - ✔✔FDA Bioresearch Monitoring program. Conducts inspections
and data audits to ensure human subject protection.
✔✔What does VAI mean? - ✔✔Voluntary Action Indicated. Grievances may be found
during an inspection, but if the regulatory agency believes the facility can correct the
issues voluntarily, then they will list VAI without formal action taken.
✔✔Within how many hours does an antibody-dependent cellular cytotoxicity reaction
typically occur? - ✔✔5-12 hours
✔✔What is a type A drug reaction? - ✔✔These are augmented reactions, they are
"dose-dependent" and have predictable pharmacology. (A=Augmented)
✔✔What is a type B drug reaction? - ✔✔These are bizarre reactions that are
idiosyncratic in nature and not predictable based on their pharmacology, "dose-
independent". (B=bizarre)
✔✔What topic does ICH E2a cover? (Generally) - ✔✔Expedited Reporting
✔✔What topic does ICH E8 cover? (Generally) - ✔✔General considerations for clinical
trials
✔✔Non-therapeutic Trial - ✔✔Trial without any expected therapeutic benefit (typically
conducted in patients with the disease)
✔✔What are the primary purposes of monitoring visits? - ✔✔Ensure the site is GCP
compliant, data is ALCOA, and patient's rights are respected.
✔✔What are "stopping rules"? - ✔✔Discontinuation Criteria
✔✔What are "Critical to quality" factors? - ✔✔Data essential for trial reliability
✔✔What are platform studies? - ✔✔Studies that allow for multiple drugs to enter/leave
the study in a continuous manner based on pre-specified rules.
