Download ACRP : ACRP-CP Questions & Answers as PDF & Test Software
Updated: Jun 11, 2026
No. of Questions: 127 Questions & Answers with Testing Engine
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ACRP Certified Professional Sample Questions:
1. A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?
A) Notify the sponsor.
B) Notify the regulatory authority.
C) Withdraw the subject.
D) Notify the subject.
2. Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?
A) Register IP in IWRS, quarantine and notify sponsor of the excursion.
B) Dispose of IP and request replacement from sponsor.
C) Quarantine IP without registering in IWRS and request replacement from sponsor.
D) Register IP in IWRS and continue with subject allocation.
3. An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?
A) DSMB/IDMC
B) PI
C) IRB/IEC
D) Sponsor
4. The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:
A) 15 calendar days
B) 30 calendar days
C) 7 calendar days
D) 8 calendar days
5. Which one of the following is a primary objective of a Phase III study of a new IP?
A) To show superiority over another treatment
B) To establish the safety profile
C) To demonstrate or confirm therapeutic benefit
D) To establish dose information
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: A | Question # 3 Answer: B | Question # 4 Answer: A | Question # 5 Answer: C |
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