ACRP CCRC EXAMS SUMMARY 2025/2026
WITH TESTED QUESTIONS AND VERIFIED
SOLUTIONS ALREADY GRADED A+
✔✔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
WITH TESTED QUESTIONS AND VERIFIED
SOLUTIONS ALREADY GRADED A+
✔✔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
