ACRP CP CERTIFICATION EXAM LATEST 2024-2025 WITH ACTUAL QUESTIONS
AND CORRECT VERIFIED ANSWERS ALREADY GRADED A+ 100% GUARANTEED
PASS!
What would be the first priority for an investigator when a subject wishes to
withdraw prematurely from the trial? - ANSWER-Try to obtain the subject's
reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC system must
conform to the established requirements for - ANSWER-Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is
to - ANSWER-maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described
in the - ANSWER-ICF
What document would an investigator reference to learn more about the
previous clinical and nonclinical results of studies of the IP? - ANSWER-
Investigators brochure
,During a multi site clinical study: whose responsibility is it to report subject
recruitment rate? - ANSWER-The CRA
An unconscious adult subject was enrolled in a study after obtaining consent
from an LAR: and protocol therapy was initiated. The subject showed
significant improvement in his clinical condition: and regained consciousness.
The Investigator should inform the subject about the study and - ANSWER-
Obtain consent from the subject for the study
A site is in the start up phase of an industry sponsored phase 3 trial: and has
received IRB approval. The site can begin enrolling subjects after... - ANSWER-A
signed clinical trial agreement between the site and sponsor is in place.
A site is screening potential subjects for a study looking at mild cognitive
impairment. One of the inclusion criteria is a score of 25 or less on a
psychometric test: a research specific tool which measures cognitive ability.
Which of the following individuals can administer the psychometric test to the
potential subjects? - ANSWER-A research assistant who is certified to
administer the psychometric test
A research study: in which there is no intended clinical benefit to the subject: is
being submitted to the IRB. What benefit information should be included in the
ICF? - ANSWER-Wording indicating that there is no expected benefit should be
included
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? - 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? - ANSWER-PI
Which of the following required elements should be included in a clinical trial
protocol? - ANSWER-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 - 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? - ANSWER-
Electronic medical record
When considering participation in a study: the investigator should determine if
he... - 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 - 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? - ANSWER-3 Years
When would an impartial witness be needed during the consent process for an
illiterate subject? - ANSWER-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 - 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? -
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? -
ANSWER-ICF
When should a research study involving human subjects be registered in a
publicly accessible database? - ANSWER-Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy of the signed
and dated ICF? - ANSWER-The subjects legally acceptable representative
A medical student is approaches by a faculty member for possible participation
in a cricothyroidotomy simulation research study. Which of the following
increases risk to the study? - ANSWER-Consenting in the presence of figure of
authority
The clinical trial phase that focuses on safety and human pharmacology in
healthy volunteers - ANSWER-Phase I
Who is ultimately responsible for all aspects of the research conducted at a
site? - ANSWER-Principal investigator
An international quality standard that is provided by ICH E6(R2) describing
safety: accuracy of trials and credibility of data - ANSWER-GCP
AND CORRECT VERIFIED ANSWERS ALREADY GRADED A+ 100% GUARANTEED
PASS!
What would be the first priority for an investigator when a subject wishes to
withdraw prematurely from the trial? - ANSWER-Try to obtain the subject's
reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC system must
conform to the established requirements for - ANSWER-Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is
to - ANSWER-maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described
in the - ANSWER-ICF
What document would an investigator reference to learn more about the
previous clinical and nonclinical results of studies of the IP? - ANSWER-
Investigators brochure
,During a multi site clinical study: whose responsibility is it to report subject
recruitment rate? - ANSWER-The CRA
An unconscious adult subject was enrolled in a study after obtaining consent
from an LAR: and protocol therapy was initiated. The subject showed
significant improvement in his clinical condition: and regained consciousness.
The Investigator should inform the subject about the study and - ANSWER-
Obtain consent from the subject for the study
A site is in the start up phase of an industry sponsored phase 3 trial: and has
received IRB approval. The site can begin enrolling subjects after... - ANSWER-A
signed clinical trial agreement between the site and sponsor is in place.
A site is screening potential subjects for a study looking at mild cognitive
impairment. One of the inclusion criteria is a score of 25 or less on a
psychometric test: a research specific tool which measures cognitive ability.
Which of the following individuals can administer the psychometric test to the
potential subjects? - ANSWER-A research assistant who is certified to
administer the psychometric test
A research study: in which there is no intended clinical benefit to the subject: is
being submitted to the IRB. What benefit information should be included in the
ICF? - ANSWER-Wording indicating that there is no expected benefit should be
included
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? - 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? - ANSWER-PI
Which of the following required elements should be included in a clinical trial
protocol? - ANSWER-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 - 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? - ANSWER-
Electronic medical record
When considering participation in a study: the investigator should determine if
he... - 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 - 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? - ANSWER-3 Years
When would an impartial witness be needed during the consent process for an
illiterate subject? - ANSWER-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 - 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? -
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? -
ANSWER-ICF
When should a research study involving human subjects be registered in a
publicly accessible database? - ANSWER-Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy of the signed
and dated ICF? - ANSWER-The subjects legally acceptable representative
A medical student is approaches by a faculty member for possible participation
in a cricothyroidotomy simulation research study. Which of the following
increases risk to the study? - ANSWER-Consenting in the presence of figure of
authority
The clinical trial phase that focuses on safety and human pharmacology in
healthy volunteers - ANSWER-Phase I
Who is ultimately responsible for all aspects of the research conducted at a
site? - ANSWER-Principal investigator
An international quality standard that is provided by ICH E6(R2) describing
safety: accuracy of trials and credibility of data - ANSWER-GCP
