ACRP CP PRACTICE PAPER 2026
QUESTIONS WITH SOLUTIONS GRADED A+
●● True or False?
Use of alternate modalities of obtaining informed consent or assent such
as use of videos, quizzes to gauge comprehension, requiring witness
signatures or requiring more than just the subject to sign consent are
examples of additional protections that may be in place to safeguard
vulnerable populations. Answer: True
●● In general, which ranks higher when conducting clinical trials?
a. ICH GCP Guidelines
b. Local Laws, Directives, or Regulations Answer: b. Local Laws,
Directives, or Regulations
●● True or false?
Clinical equipoise is considered to be a necessary feature for the ethical
enrollment of participants into a clinical trial. Answer: True
●● True or False?
,One important distinction between standard of care medical treatment
and clinical research is that the intent of medical treatment is to address
the needs of an individual patient in the here and now, whereas clinical
research is intended to answer questions about whether a treatment or
procedure could benefit large groups of people in the future. Answer:
True
●● True or false?
Generally speaking, sponsors must report SUSARs (Serious Suspected
Unexpected Serious Adverse Reactions) to the regulatory authorities
within 5 days (if a death or life-threatening event) or within 10 days for
all other SUSARs. Answer: False
●● True or false?
In almost all situations, research needs trump or prevail over an
individual's basic privacy rights. Answer: False
●● Why are vulnerable populations named as such?
a. May be vulnerable to undue influence or coercion.
b. Have limited comprehension or ability to understand information.
, c. Could likely bias the results of the research.
d. All of the above
e. A and B only Answer: e. A and B only
●● What is true of an impartial witness?
a. Should always be present during the informed consent process
b. Is required during the informed consent process for all vulnerable
subjects
c. Should attend the informed consent process is the subject or their
legally acceptable representative cannot read
d. Should be independent of the trial
e. All of the above
f. C and D only Answer: f. C and D only
●● True or false?
One benefit of transparent reporting of trial results is that it enables the
reader to judge the reliability and validity of trial results. Answer: True
●● As part of their risk assessment process, the sponsor determines that
there is a high likelihood that enrollment in the trial will be challenging
and slow. Which of the following is the best choice in this situation:
QUESTIONS WITH SOLUTIONS GRADED A+
●● True or False?
Use of alternate modalities of obtaining informed consent or assent such
as use of videos, quizzes to gauge comprehension, requiring witness
signatures or requiring more than just the subject to sign consent are
examples of additional protections that may be in place to safeguard
vulnerable populations. Answer: True
●● In general, which ranks higher when conducting clinical trials?
a. ICH GCP Guidelines
b. Local Laws, Directives, or Regulations Answer: b. Local Laws,
Directives, or Regulations
●● True or false?
Clinical equipoise is considered to be a necessary feature for the ethical
enrollment of participants into a clinical trial. Answer: True
●● True or False?
,One important distinction between standard of care medical treatment
and clinical research is that the intent of medical treatment is to address
the needs of an individual patient in the here and now, whereas clinical
research is intended to answer questions about whether a treatment or
procedure could benefit large groups of people in the future. Answer:
True
●● True or false?
Generally speaking, sponsors must report SUSARs (Serious Suspected
Unexpected Serious Adverse Reactions) to the regulatory authorities
within 5 days (if a death or life-threatening event) or within 10 days for
all other SUSARs. Answer: False
●● True or false?
In almost all situations, research needs trump or prevail over an
individual's basic privacy rights. Answer: False
●● Why are vulnerable populations named as such?
a. May be vulnerable to undue influence or coercion.
b. Have limited comprehension or ability to understand information.
, c. Could likely bias the results of the research.
d. All of the above
e. A and B only Answer: e. A and B only
●● What is true of an impartial witness?
a. Should always be present during the informed consent process
b. Is required during the informed consent process for all vulnerable
subjects
c. Should attend the informed consent process is the subject or their
legally acceptable representative cannot read
d. Should be independent of the trial
e. All of the above
f. C and D only Answer: f. C and D only
●● True or false?
One benefit of transparent reporting of trial results is that it enables the
reader to judge the reliability and validity of trial results. Answer: True
●● As part of their risk assessment process, the sponsor determines that
there is a high likelihood that enrollment in the trial will be challenging
and slow. Which of the following is the best choice in this situation:
