Pass the actual test with the help of ACRP-CP study guide
Updated: Jun 23, 2026
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1. Which of the following elements of the Informed Consent are NOT required?
A) Subject legal rights can be waived
B) A description of any reasonably foreseeable risks or discomforts
C) A description of potential benefits
D) Statement that study involves research
2. An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?
A) Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
B) Add the risk of infection to the ICF and submit to the IRB/IEC for review.
C) Update the IB to add the risk of infection and submit to the sponsor for approval.
D) Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
3. What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?
A) Inspection
B) Routine monitoring
C) Site qualification
D) Audit
4. Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?
A) CRA
B) Data Manager
C) Sponsor
D) CRO
5. While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?
A) Locate a translator and have them work with the person.
B) Have the Principal Investigator consent the person.
C) Get an impartial witness involved in consenting this person.
D) There are no circumstances under which this person can be enrolled.
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: A | Question # 3 Answer: D | Question # 4 Answer: C | Question # 5 Answer: C |
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