ACRP-CP Certification Exam QUESTIONS WITH ANSWERS

ACRP-CP Certification Exam |\ |\ |\




QUESTIONS WITH ANSWERS |\ |\




What would be the first priority for an investigator when a
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subject wishes to withdraw prematurely from the trial? -
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CORRECT ANSWERS ✔✔Try to obtain the subject's reason for
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withdrawal.


CRO recently switched from paper CRF to an EDC system. The
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EDC system must conform to the established requirements for -
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CORRECT ANSWERS ✔✔Validation |\ |\




Accuracy
Reliability
Completeness


Part of a sponsor's responsibility pertaining to electronic trial data
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handling is to - CORRECT ANSWERS ✔✔maintain an audit trail,
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data trail, and edit trail.
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A research subject's responsibilities for study participation should
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be described in the - CORRECT ANSWERS ✔✔ICF
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What document would an investigator reference to learn more
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about the previous clinical and nonclinical results of studies of
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the IP? - CORRECT ANSWERS ✔✔Investigators brochure
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,During a multi site clinical study: whose responsibility is it to
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report subject recruitment rate? - CORRECT ANSWERS ✔✔The
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CRA


An unconscious adult subject was enrolled in a study after
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obtaining consent from an LAR: and protocol therapy was
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initiated. The subject showed significant improvement in his
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clinical condition: and regained consciousness. The Investigator
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should inform the subject about the study and - CORRECT
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ANSWERS ✔✔Obtain consent from the subject for the study |\ |\ |\ |\ |\ |\ |\ |\




A site is in the start up phase of an industry sponsored phase 3
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trial: and has received IRB approval. The site can begin enrolling
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subjects after... - CORRECT ANSWERS ✔✔A signed clinical trial
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agreement between the site and sponsor is in place. |\ |\ |\ |\ |\ |\ |\ |\




A site is screening potential subjects for a study looking at mild
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cognitive impairment. One of the inclusion criteria is a score of
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25 or less on a psychometric test: a research specific tool which
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measures cognitive ability. Which of the following individuals can
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administer the psychometric test to the potential subjects? - |\ |\ |\ |\ |\ |\ |\ |\ |\


CORRECT ANSWERS ✔✔A research assistant who is certified to
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administer the psychometric test |\ |\ |\




A research study: in which there is no intended clinical benefit to
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the subject: is being submitted to the IRB. What benefit
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information should be included in the ICF? - CORRECT ANSWERS |\ |\ |\ |\ |\ |\ |\ |\ |\ |\


✔✔Wording indicating that there is no expected benefit should be |\ |\ |\ |\ |\ |\ |\ |\ |\


included
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,A CRA notices during an onsite visit that the date on IRB approval
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letter for a protocol is prior to the effective date indicated on the
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cover page of the protocol and the signatures of the investigator
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and sponsor. What should the CRA do FIRST? - CORRECT
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ANSWERS ✔✔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
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was terminated due to an increased risk of cancer in subjects.
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Who is responsible for providing a written report to the IRB? -
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CORRECT ANSWERS ✔✔PI |\ |\




Which of the following required elements should be included in a
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clinical trial protocol? - CORRECT ANSWERS ✔✔Subject inclusion
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and exclusion criteria
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Prior to archiving a study: documentation of IP destruction at the
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site should be filed in the study files of the - CORRECT ANSWERS
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✔✔PI and Sponsor |\ |\




During a monitoring visit: what records would a CRA reference to
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verify a subject's compliance to the study visit schedule and
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assessments? - CORRECT ANSWERS ✔✔Electronic medical record |\ |\ |\ |\ |\ |\




When considering participation in a study: the investigator should
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determine if he... - CORRECT ANSWERS ✔✔Sees enough patients
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who would qualify for the study
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, New safety information has become available from the Sponsor
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about the IP being used in a clinical trial. The investigator must -
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CORRECT ANSWERS ✔✔Submit a revised ICF to the IRB noting
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the new safety information
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Per ICH: an IRB must keep correspondence for at least how long
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after the completion of a clinical trial? - CORRECT ANSWERS ✔✔3
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Years
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When would an impartial witness be needed during the consent
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process for an illiterate subject? - CORRECT ANSWERS ✔✔To
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observe the consent process |\ |\ |\




A study which seeks to determine the ideal dose and regimen of
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a new IP to treat hypothyroidism is considered to be - CORRECT
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ANSWERS ✔✔Phase II |\ |\




After completion of a study: the final trial close out monitoring
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report prepared by the CRA should be filed in which of the
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following stakeholder files? - CORRECT ANSWERS ✔✔The
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sponsors files |\




A blood sample collection is required to screen for bloodborne
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pathogens before subject could be enrolled in a study. Where will
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subjects find information of the procedures and any foreseeable
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risks or inconveniences? - CORRECT ANSWERS ✔✔ICF
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