ACRP CCRC LATEST 2026 PRACTICE EXAM QUESTIONS
AND ANSWERS GRADED A+
✔✔What is the NAI classification of an FDA audit - ✔✔No objectionable conditions or
practices were found during inspection
✔✔What is the OAI classification of an FDA audit - ✔✔Regulatory and/or administrative
actions are recommended
✔✔The day before a CRA is to conduct an initiation visit, the CRC realizes that the
IRB/IEC approval letter has not yet been obtained. Which of the following should the
CRC do FIRST?
Request an expedited IRB/IEC review.
Reschedule the initiation visit.
Call the IRB/IEC to check the status of the letter.
Call the sponsor to have the files checked. - ✔✔Call the IRB/IEC to check the status of
the letter.
✔✔According to the Belmont Report, the process of informed consent requires which 3
components to be adequately addressed to be considered ethically valid? -
✔✔1)Information
2)Understanding
3) Voluntary Agreement
✔✔What phase trials typically have non- therapeutic objectives, are intended to
determine tolerability of dose ranges for future trials, and determine the nature of
adverse events that may be expected? Small groups of subjects are typically enrolled. -
✔✔Phase I
✔✔What phase trials are usually considered to start with the initiation of studies in
which the primary objective is to explore therapeutic efficacy. - ✔✔Phase II
✔✔A small biotech company is investigating the anti-tumoral potential of scorpion toxin
in high grade recurrent brain tumors. After animal trials have been completed, the first
trial in humans would MOST likely involve:
1. healthy volunteers
2. pharmacokinetic analysis
3. placebo control
4. dose escalation
A) 1 and 3 only
B) 1 and 4 only
C) 2 and 3 only
D) 2 and 4 only - ✔✔D
AND ANSWERS GRADED A+
✔✔What is the NAI classification of an FDA audit - ✔✔No objectionable conditions or
practices were found during inspection
✔✔What is the OAI classification of an FDA audit - ✔✔Regulatory and/or administrative
actions are recommended
✔✔The day before a CRA is to conduct an initiation visit, the CRC realizes that the
IRB/IEC approval letter has not yet been obtained. Which of the following should the
CRC do FIRST?
Request an expedited IRB/IEC review.
Reschedule the initiation visit.
Call the IRB/IEC to check the status of the letter.
Call the sponsor to have the files checked. - ✔✔Call the IRB/IEC to check the status of
the letter.
✔✔According to the Belmont Report, the process of informed consent requires which 3
components to be adequately addressed to be considered ethically valid? -
✔✔1)Information
2)Understanding
3) Voluntary Agreement
✔✔What phase trials typically have non- therapeutic objectives, are intended to
determine tolerability of dose ranges for future trials, and determine the nature of
adverse events that may be expected? Small groups of subjects are typically enrolled. -
✔✔Phase I
✔✔What phase trials are usually considered to start with the initiation of studies in
which the primary objective is to explore therapeutic efficacy. - ✔✔Phase II
✔✔A small biotech company is investigating the anti-tumoral potential of scorpion toxin
in high grade recurrent brain tumors. After animal trials have been completed, the first
trial in humans would MOST likely involve:
1. healthy volunteers
2. pharmacokinetic analysis
3. placebo control
4. dose escalation
A) 1 and 3 only
B) 1 and 4 only
C) 2 and 3 only
D) 2 and 4 only - ✔✔D
