ACRP CCRC LATEST 2026 EXAM SET QUESTIONS AND
ANSWERS GRADED A+
✔✔What is the Investigator's Brochure? - ✔✔A compilation of data on an investigational
product used in human subjects
✔✔What does IB stand for? - ✔✔Investigator's Brochure
✔✔What does BID mean, in terms of dosing? - ✔✔Twice per day
✔✔What does QD mean, in terms of dosing? - ✔✔Once daily
✔✔What does QID mean, in terms of dosing? - ✔✔Four times per day
✔✔What does TID mean, in terms of dosing? - ✔✔Three times per day
✔✔In this type of study, both the subject & research staff are unaware of the identity of
the study medication. - ✔✔Double blind
✔✔What is the formula to calculate study drug compliance? - ✔✔"What was taken"
divided by "what should have been taken"
✔✔What is the conversion from pounds (lb) to kilograms (kg)? - ✔✔1lb = 0.454kg; 1kg
= 2.20lb
✔✔What 2 conditions must be fulfilled when enrolling a subject onto a trial? - ✔✔1.
Subject meets inclusion criteria
2. Subject has provided written informed consent
✔✔Which 2 individuals must sign & date the informed consent form? - ✔✔1. The
subject
2. The person obtaining consent
✔✔What is a subject identification code? - ✔✔A unique identifier that is assigned by the
investigator, to be used in place of a subject's name, to protect their identity during
reporting
✔✔What does ICH stand for? - ✔✔International Conference on Harmonization
✔✔What is an audit? - ✔✔A review of how research was conducted, to evaluate
compliance; takes into account SOPs, IRB requirements, and GCP
✔✔A CRO has been enlisted to oversee a study. Who is primarily responsible for the
integrity of trial data? - ✔✔The sponsor
, ✔✔The term "life-threatening", in terms of a serious adverse event, refers to:
A. An event requiring hospitalization
B. An event in which risk of death was imminent at the time of the event
C. An event that required treatment in an emergency room
D. An event that might have caused a death, if untreated - ✔✔B. An event in which risk
of death was imminent at the time of the event
✔✔A patient in a clinical trial for joint pain experiences a bronchospasm while at home.
This event is best described as:
A. Not reportable because it occurred in a home setting
B. An adverse event, which does not require reporting
C. An unexpected adverse event, which does not require expedited reporting
D. May be considered serious and should be considered for expedited reporting - ✔✔D.
May be considered serious and should be considered for expedited reporting
✔✔An unexpected adverse reaction is one which is:
A. Not expected by the investigator
B. Not mentioned in the Investigator's Brochure or relevant source document
C. Classified as such by the IRB
D. Classified as such by the sponsor's medical safety officer - ✔✔B. Not mentioned in
the Investigator's Brochure or relevant source document
✔✔What does IDMC stand for? - ✔✔Independent Data Monitoring Committee
✔✔Fatal or life-threatening ADRs should be submitted within what time frame? -
✔✔ASAP, but no later than 7 days
✔✔Serious ADRs should be submitted within what time frame? - ✔✔ASAP, but no later
than 15 days
✔✔How often should an Investigator's Brochure be reviewed? - ✔✔At least annually,
and revised as necessary
✔✔Who is responsible for ensuring that the IRB/IEC has the most up-to-date IB?
A. Sponsor
B. PI
C. Monitor
D. CRC - ✔✔B. PI
✔✔The ethical principles underlying clinical study management are stated in:
A. Declaration of Helsinki
B. Nuremburg Report
C. Belmont Report
ANSWERS GRADED A+
✔✔What is the Investigator's Brochure? - ✔✔A compilation of data on an investigational
product used in human subjects
✔✔What does IB stand for? - ✔✔Investigator's Brochure
✔✔What does BID mean, in terms of dosing? - ✔✔Twice per day
✔✔What does QD mean, in terms of dosing? - ✔✔Once daily
✔✔What does QID mean, in terms of dosing? - ✔✔Four times per day
✔✔What does TID mean, in terms of dosing? - ✔✔Three times per day
✔✔In this type of study, both the subject & research staff are unaware of the identity of
the study medication. - ✔✔Double blind
✔✔What is the formula to calculate study drug compliance? - ✔✔"What was taken"
divided by "what should have been taken"
✔✔What is the conversion from pounds (lb) to kilograms (kg)? - ✔✔1lb = 0.454kg; 1kg
= 2.20lb
✔✔What 2 conditions must be fulfilled when enrolling a subject onto a trial? - ✔✔1.
Subject meets inclusion criteria
2. Subject has provided written informed consent
✔✔Which 2 individuals must sign & date the informed consent form? - ✔✔1. The
subject
2. The person obtaining consent
✔✔What is a subject identification code? - ✔✔A unique identifier that is assigned by the
investigator, to be used in place of a subject's name, to protect their identity during
reporting
✔✔What does ICH stand for? - ✔✔International Conference on Harmonization
✔✔What is an audit? - ✔✔A review of how research was conducted, to evaluate
compliance; takes into account SOPs, IRB requirements, and GCP
✔✔A CRO has been enlisted to oversee a study. Who is primarily responsible for the
integrity of trial data? - ✔✔The sponsor
, ✔✔The term "life-threatening", in terms of a serious adverse event, refers to:
A. An event requiring hospitalization
B. An event in which risk of death was imminent at the time of the event
C. An event that required treatment in an emergency room
D. An event that might have caused a death, if untreated - ✔✔B. An event in which risk
of death was imminent at the time of the event
✔✔A patient in a clinical trial for joint pain experiences a bronchospasm while at home.
This event is best described as:
A. Not reportable because it occurred in a home setting
B. An adverse event, which does not require reporting
C. An unexpected adverse event, which does not require expedited reporting
D. May be considered serious and should be considered for expedited reporting - ✔✔D.
May be considered serious and should be considered for expedited reporting
✔✔An unexpected adverse reaction is one which is:
A. Not expected by the investigator
B. Not mentioned in the Investigator's Brochure or relevant source document
C. Classified as such by the IRB
D. Classified as such by the sponsor's medical safety officer - ✔✔B. Not mentioned in
the Investigator's Brochure or relevant source document
✔✔What does IDMC stand for? - ✔✔Independent Data Monitoring Committee
✔✔Fatal or life-threatening ADRs should be submitted within what time frame? -
✔✔ASAP, but no later than 7 days
✔✔Serious ADRs should be submitted within what time frame? - ✔✔ASAP, but no later
than 15 days
✔✔How often should an Investigator's Brochure be reviewed? - ✔✔At least annually,
and revised as necessary
✔✔Who is responsible for ensuring that the IRB/IEC has the most up-to-date IB?
A. Sponsor
B. PI
C. Monitor
D. CRC - ✔✔B. PI
✔✔The ethical principles underlying clinical study management are stated in:
A. Declaration of Helsinki
B. Nuremburg Report
C. Belmont Report
