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ACRP CP EXAM NEWEST 2024-2025 ACTUAL
EXAM COMPLETE 100 QUESTIONS AND
CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) |ALREADY GRADED A+
A CRA notices during an onsite visit that the date on IRB
approval letter for a protocol is prior to the effective date
indicated on the cover page of the protocol and the signatures of
the investigator and sponsor. What should the CRA do FIRST? -
CORRECT ANSWER-Confirm dates of initial receipt of the
sponsor protocol and the IRB submission dates.
In a multi arm, randomized clinical trial, one arm of the protocol
was terminated due to an increased risk of cancer in subjects.
Who is responsible for providing a written report to the IRB? -
CORRECT ANSWER-PI
Which of the following required elements should be included in
a clinical trial protocol? - CORRECT ANSWER-Subject
inclusion and exclusion criteria
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Prior to archiving a study, documentation of IP destruction at the
site should be filed in the study files of the - CORRECT
ANSWER-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? - CORRECT ANSWER-Electronic medical record
When considering participation in a study, the investigator
should determine if he... - CORRECT ANSWER-Sees enough
patients who would qualify for the study
New safety information has become available from the Sponsor
about the IP being used in a clinical trial. The investigator must:
- CORRECT ANSWER-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? - CORRECT ANSWER-
3 Years
When would an impartial witness be needed during the consent
process for an illiterate subject? - CORRECT ANSWER-To
observe the consent process
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A study which seeks to determine the ideal dose and regimen of
a new IP to treat hypothyroidism is considered to be: -
CORRECT ANSWER-Phase II
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? - CORRECT ANSWER-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? - CORRECT ANSWER-
ICF
When should a research study involving human subjects be
registered in a publicly accessible database? - CORRECT
ANSWER-Before recruiting the first subject
In the case of an incapacitated subject, who should receive a
copy of the signed and dated ICF? - CORRECT ANSWER-The
subjects legally acceptable representative
A medical student is approaches by a faculty member for
possible participation in a cricothyroidotomy simulation
Version | 2025 |
Category | Study Material |
Release date | 2024-10-25 |
Latest update | 2024-10-25 |
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