1|Page
ACRP-CP Certification Exam Questions
and Answers Latest 2025 Top Rated A+
Which of the following required elements should be included in a
clinical trial protocol?
Ans: Subject inclusion and exclusion criteria
Prior to archiving a study: documentation of IP destruction at the site
should be filed in the study files of the
Ans: PI and Sponsor
During a monitoring visit: what records would a CRA reference to
verify a subject's compliance to the study visit schedule and
assessments?
Ans: Electronic medical record
When considering participation in a study: the investigator should
determine if he...
,2|Page
Ans: Sees enough patients who would qualify for the study
,3|Page
New safety information has become available from the Sponsor
about the IP being used in a clinical trial. The investigator must
Ans: Submit a revised ICF to the IRB noting the new safety information
Per ICH: an IRB must keep correspondence for at least how long
after the completion of a clinical trial?
Ans: 3 Years
When would an impartial witness be needed during the consent
process for an illiterate subject?
Ans: To observe the consent process
A study which seeks to determine the ideal dose and regimen of a
new IP to treat hypothyroidism is considered to be
Ans: Phase II
, 4|Page
After completion of a study: the final trial close out monitoring report
prepared by the CRA should be filed in which of the following
stakeholder files?
Ans: The sponsors files
A blood sample collection is required to screen for bloodborne
pathogens before subject could be enrolled in a study. Where will
subjects find information of the procedures and any foreseeable risks
or inconveniences?
Ans: ICF
When should a research study involving human subjects be
registered in a publicly accessible database?
Ans: Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy
of the signed and dated ICF?
ACRP-CP Certification Exam Questions
and Answers Latest 2025 Top Rated A+
Which of the following required elements should be included in a
clinical trial protocol?
Ans: Subject inclusion and exclusion criteria
Prior to archiving a study: documentation of IP destruction at the site
should be filed in the study files of the
Ans: PI and Sponsor
During a monitoring visit: what records would a CRA reference to
verify a subject's compliance to the study visit schedule and
assessments?
Ans: Electronic medical record
When considering participation in a study: the investigator should
determine if he...
,2|Page
Ans: Sees enough patients who would qualify for the study
,3|Page
New safety information has become available from the Sponsor
about the IP being used in a clinical trial. The investigator must
Ans: Submit a revised ICF to the IRB noting the new safety information
Per ICH: an IRB must keep correspondence for at least how long
after the completion of a clinical trial?
Ans: 3 Years
When would an impartial witness be needed during the consent
process for an illiterate subject?
Ans: To observe the consent process
A study which seeks to determine the ideal dose and regimen of a
new IP to treat hypothyroidism is considered to be
Ans: Phase II
, 4|Page
After completion of a study: the final trial close out monitoring report
prepared by the CRA should be filed in which of the following
stakeholder files?
Ans: The sponsors files
A blood sample collection is required to screen for bloodborne
pathogens before subject could be enrolled in a study. Where will
subjects find information of the procedures and any foreseeable risks
or inconveniences?
Ans: ICF
When should a research study involving human subjects be
registered in a publicly accessible database?
Ans: Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy
of the signed and dated ICF?
