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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. Who determines the age of assent for pediatric studies?

A) Sponsor
B) PI
C) IRB/IEC
D) Parent

2. 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) Routine monitoring
B) Inspection
C) Audit
D) Site qualification

3. During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

A) Verify compliance with IP regimen.
B) Validate protocol endpoints.
C) Conduct safety analysis.
D) Evaluate study data.

4. While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?

A) Get an impartial witness involved in consenting this person.
B) Locate a translator and have them work with the person.
C) Have the Principal Investigator consent the person.
D) There are no circumstances under which this person can be enrolled.

5. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A) Any trial-related duties can be documented as transferred by verbal agreement.
B) All duties transferred to a CRO should be specified in writing.
C) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
D) The IRB/IEC must approve the transfer of duties to a CRO.

Solutions: