ACRP CCRC LATEST 2026 STUDYS EXAM QUESTIONS AND
ANSWERS GRADED A+
✔✔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
D. CIOMS guidelines - ✔✔A. Declaration of Helsinki
✔✔Clinical trial protocols should reflect:
A. Reasonable costs for conducting the trial
B. Minimal sample sizes to reduce risk
C. Sound study design
D. The use of control groups wherever possible - ✔✔C. Sound study design
✔✔ICH defined human pharmacology trials are:
A. Phase I
B. Phase II
C. Phase III
D. Phase IV - ✔✔A. Phase I
✔✔ICH defined therapeutic exploratory studies are likely to be:
A. Phase I
B. Phase II
C. Phase III
D. Phase IV - ✔✔B. Phase II
✔✔ICH defined therapeutic confirmatory studies are likely to be:
A. Phase I
B. Phase II
C. Phase III
D. Phase IV - ✔✔C. Phase III
✔✔ICH defined therapeutic use studies are likely to be:
A. Phase I
B. Phase II
C. Phase III
D. Phase IV - ✔✔D. Phase IV
, ✔✔Studies that examine dose tolerance, pharmacokinetic & pharmacodynamic aspects
of a drug are likely to be:
A. Human pharmacology
B. Therapeutic exploratory
C. Therapeutic confirmatory
D. Therapeutic use - ✔✔A. Human pharmacology
✔✔Characterization of a drug's absorption, metabolism, and excretion:
A. Are confined to Phase I trials
B. Can be conducted during Phase II trials, if Phase I studies are inconclusive
C. Are never studied in Phase III trials
D. Continue throughout the development plan - ✔✔D. Continue throughout the
development plan
✔✔Who is responsible for ensuring accurate & complete accountability and proper
storage of investigational products used in clinical trials? - ✔✔The PI
✔✔Investigational product dispensing is or administration information for the sponsor is
recorded where? - ✔✔Case report form (CRF)
✔✔Where is information on the storage requirements for an investigational product
usually found? - ✔✔Study protocol
✔✔Who is responsible for monitoring the progress of the trial and ensuring that sites
are conducting the study in accordance with the protocol, regulations, and ethical
considerations? - ✔✔The sponsor
✔✔Who is responsible for the timely collection, assessment, and reporting of adverse
events and other safety-related information throughout a trial? - ✔✔The sponsor
✔✔Who develops standard operating procedures (SOPs)? - ✔✔The sponsor
✔✔At minimum, how often should an investigator submit written summaries of trial
progress to the IRB? - ✔✔Annually
✔✔True or False: High risk trials must be reviewed by the IRB every 6 months. -
✔✔False. Trials must be reviewed annually but *may* be required to be reviewed on a
more frequent basis.
✔✔The packaging of investigational products should ideally:
A. Look like a marketed product
B. Allow subjects to distinguish placebo pills
ANSWERS GRADED A+
✔✔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
D. CIOMS guidelines - ✔✔A. Declaration of Helsinki
✔✔Clinical trial protocols should reflect:
A. Reasonable costs for conducting the trial
B. Minimal sample sizes to reduce risk
C. Sound study design
D. The use of control groups wherever possible - ✔✔C. Sound study design
✔✔ICH defined human pharmacology trials are:
A. Phase I
B. Phase II
C. Phase III
D. Phase IV - ✔✔A. Phase I
✔✔ICH defined therapeutic exploratory studies are likely to be:
A. Phase I
B. Phase II
C. Phase III
D. Phase IV - ✔✔B. Phase II
✔✔ICH defined therapeutic confirmatory studies are likely to be:
A. Phase I
B. Phase II
C. Phase III
D. Phase IV - ✔✔C. Phase III
✔✔ICH defined therapeutic use studies are likely to be:
A. Phase I
B. Phase II
C. Phase III
D. Phase IV - ✔✔D. Phase IV
, ✔✔Studies that examine dose tolerance, pharmacokinetic & pharmacodynamic aspects
of a drug are likely to be:
A. Human pharmacology
B. Therapeutic exploratory
C. Therapeutic confirmatory
D. Therapeutic use - ✔✔A. Human pharmacology
✔✔Characterization of a drug's absorption, metabolism, and excretion:
A. Are confined to Phase I trials
B. Can be conducted during Phase II trials, if Phase I studies are inconclusive
C. Are never studied in Phase III trials
D. Continue throughout the development plan - ✔✔D. Continue throughout the
development plan
✔✔Who is responsible for ensuring accurate & complete accountability and proper
storage of investigational products used in clinical trials? - ✔✔The PI
✔✔Investigational product dispensing is or administration information for the sponsor is
recorded where? - ✔✔Case report form (CRF)
✔✔Where is information on the storage requirements for an investigational product
usually found? - ✔✔Study protocol
✔✔Who is responsible for monitoring the progress of the trial and ensuring that sites
are conducting the study in accordance with the protocol, regulations, and ethical
considerations? - ✔✔The sponsor
✔✔Who is responsible for the timely collection, assessment, and reporting of adverse
events and other safety-related information throughout a trial? - ✔✔The sponsor
✔✔Who develops standard operating procedures (SOPs)? - ✔✔The sponsor
✔✔At minimum, how often should an investigator submit written summaries of trial
progress to the IRB? - ✔✔Annually
✔✔True or False: High risk trials must be reviewed by the IRB every 6 months. -
✔✔False. Trials must be reviewed annually but *may* be required to be reviewed on a
more frequent basis.
✔✔The packaging of investigational products should ideally:
A. Look like a marketed product
B. Allow subjects to distinguish placebo pills
