ACRP CP FINAL STUDY GUIDE 2026
SOLVED QUESTIONS FULLY CORRECT
⫸ What event resulted in the Nuremburg Cod of 1949? Answer: Nazi
Medical Experiments
⫸ Who does the investigator need to inform if he/she deviates from the
protocol? (Select all that apply)
a. The sponsor b. The regulatory authorities c. The office staff d. The
IRB/IEC Answer: The sponsor, The regulatory authorities, The IRB/IEC
⫸ Who should have access to the trial files? (Select all that apply)
a. The subiect b. The monitor c. The investigator d. The pharmacist
Answer: The monitor, The investigator
⫸ An Adverse Event (AE) that is severe in intensity:
a. Is always classified as serious b. Is never classified as serious c. May
not meet the definition of serious d. Should be submitted to the sponsor
within 24 hours Answer: May not meet the definition of serious
⫸ Which of the following is always true?
a. Adverse Drug Reactions (ADRs) are evidence that the drug is
working b. An Adverse Drug Reaction (ADR) is an Adverse Event (AE)
c. An Adverse Event (AE) is an Adverse Drug Reaction (ADR) d.
, Adverse Events (AEs) are less frequently observed in placebo arms.
Answer: An Adverse Drug Reaction (ADR) is an Adverse Event (AE)
⫸ Which of the following tasks is the investigator responsible for?
(Select all that apply)
a. Treating the subject if an Adverse Event (A) occurs in the case the
investigator is a qualified physician or dentist b. Make reasonable efforts
to ascertain the reasons for a subject's premature withdrawal from the
trial c. Encouraging subjects to report all Adverse Events (AEs) d. Upon
permission of the subject, inform primary physician of subject's
participation in the trial Answer: a. Treating the subject if an Adverse
Event (A) occurs in the case the investigator is a qualified physician or
dentistb. Make reasonable efforts to ascertain the reasons for a subject's
premature withdrawal from the trialc. Encouraging subjects to report all
Adverse Events (AEs)d. Upon permission of the subject, inform primary
physician of subject's participation in the trial
⫸ A non-English speaking subject has responded to a recruitment ad to
participate in a trial for treatment of her diabetes. She arrives at the site
with her daughter who is fluent in English. The informed consent forms
are only available in English. What actions are compliant with GCP?
a. Find a member of the clinic staff who speaks the same language as the
subject to serve as the interpreter. b. Contact the IRB/IC and ask for an
exemption to screen subject. c. Call the sponsor to request a translation
of the informed consent. d. Ask the subject's daughter to serve as
interpreter and read the consent form to the subject. Answer: c. Call the
sponsor to request a translation of the informed consent.
SOLVED QUESTIONS FULLY CORRECT
⫸ What event resulted in the Nuremburg Cod of 1949? Answer: Nazi
Medical Experiments
⫸ Who does the investigator need to inform if he/she deviates from the
protocol? (Select all that apply)
a. The sponsor b. The regulatory authorities c. The office staff d. The
IRB/IEC Answer: The sponsor, The regulatory authorities, The IRB/IEC
⫸ Who should have access to the trial files? (Select all that apply)
a. The subiect b. The monitor c. The investigator d. The pharmacist
Answer: The monitor, The investigator
⫸ An Adverse Event (AE) that is severe in intensity:
a. Is always classified as serious b. Is never classified as serious c. May
not meet the definition of serious d. Should be submitted to the sponsor
within 24 hours Answer: May not meet the definition of serious
⫸ Which of the following is always true?
a. Adverse Drug Reactions (ADRs) are evidence that the drug is
working b. An Adverse Drug Reaction (ADR) is an Adverse Event (AE)
c. An Adverse Event (AE) is an Adverse Drug Reaction (ADR) d.
, Adverse Events (AEs) are less frequently observed in placebo arms.
Answer: An Adverse Drug Reaction (ADR) is an Adverse Event (AE)
⫸ Which of the following tasks is the investigator responsible for?
(Select all that apply)
a. Treating the subject if an Adverse Event (A) occurs in the case the
investigator is a qualified physician or dentist b. Make reasonable efforts
to ascertain the reasons for a subject's premature withdrawal from the
trial c. Encouraging subjects to report all Adverse Events (AEs) d. Upon
permission of the subject, inform primary physician of subject's
participation in the trial Answer: a. Treating the subject if an Adverse
Event (A) occurs in the case the investigator is a qualified physician or
dentistb. Make reasonable efforts to ascertain the reasons for a subject's
premature withdrawal from the trialc. Encouraging subjects to report all
Adverse Events (AEs)d. Upon permission of the subject, inform primary
physician of subject's participation in the trial
⫸ A non-English speaking subject has responded to a recruitment ad to
participate in a trial for treatment of her diabetes. She arrives at the site
with her daughter who is fluent in English. The informed consent forms
are only available in English. What actions are compliant with GCP?
a. Find a member of the clinic staff who speaks the same language as the
subject to serve as the interpreter. b. Contact the IRB/IC and ask for an
exemption to screen subject. c. Call the sponsor to request a translation
of the informed consent. d. Ask the subject's daughter to serve as
interpreter and read the consent form to the subject. Answer: c. Call the
sponsor to request a translation of the informed consent.
