CCRP Practice Questions(Latest Exam
2024
Prior to archiving a study, documentation of IP
destruction at the site should be filed in the study files of
the: - correct answers✅PI and Sponsor.
In the case of an incapacitated subject, who should
receive a copy of the signed and dated ICF? - correct
answers✅The subject's legally acceptable
representative
Which of the following required elements should be
included in a clinical trial protocol? - correct
answers✅The subject inclusion and exclusion criteria
During a multi-site clinical study, whose responsibility is it
to report subject recruitment rate? - correct
answers✅The CRA
A study which seeks to determine the ideal dose and
regimen of a new IP to treat hypothyroidism is considered
to be: - correct answers✅Phase II
What document would an investigator reference to learn
more about the previous clinical and nonclinical results of
studies of the IP? - correct answers✅IB
,CCRP Practice Questions(Latest Exam
2024
When considering participation in a study, the
investigator should determine if he/she: - correct
answers✅sees enough patients who would qualify for
the study.
When would an impartial witness be needed during the
consent process for an illiterate subject? - correct
answers✅To observe the consent process
During a monitoring visit, what records would a CRA
reference to verify a subject's compliance to the study
visit schedule and assessments? - correct
answers✅Electronic medical record
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? - correct
answers✅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/IEC.
What benefit information should be included in the ICF? -
, CCRP Practice Questions(Latest Exam
2024
correct answers✅Wording indicating that there is no
expected benefit should be included.
A research subject's responsibilities for study
participation should be described in the: - correct
answers✅ICF
New safety information has become available from the
Sponsor about the IP being used in a clinical trial. The
Investigator must: - correct answers✅submit a revised
ICF to the IRB/IEC noting the new safety information.
A medical student is approached by a faculty member for
possible participation in a cricothyroidotomy simulation
research study. Which of the following increases risk to
the subject? - correct answers✅Consenting in the
presence of figure of authority
What would be the first priority for an investigator when a
subject wishes to withdraw prematurely from the trial? -
correct answers✅Try to obtain the subject's reason for
withdrawal.
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
2024
Prior to archiving a study, documentation of IP
destruction at the site should be filed in the study files of
the: - correct answers✅PI and Sponsor.
In the case of an incapacitated subject, who should
receive a copy of the signed and dated ICF? - correct
answers✅The subject's legally acceptable
representative
Which of the following required elements should be
included in a clinical trial protocol? - correct
answers✅The subject inclusion and exclusion criteria
During a multi-site clinical study, whose responsibility is it
to report subject recruitment rate? - correct
answers✅The CRA
A study which seeks to determine the ideal dose and
regimen of a new IP to treat hypothyroidism is considered
to be: - correct answers✅Phase II
What document would an investigator reference to learn
more about the previous clinical and nonclinical results of
studies of the IP? - correct answers✅IB
,CCRP Practice Questions(Latest Exam
2024
When considering participation in a study, the
investigator should determine if he/she: - correct
answers✅sees enough patients who would qualify for
the study.
When would an impartial witness be needed during the
consent process for an illiterate subject? - correct
answers✅To observe the consent process
During a monitoring visit, what records would a CRA
reference to verify a subject's compliance to the study
visit schedule and assessments? - correct
answers✅Electronic medical record
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? - correct
answers✅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/IEC.
What benefit information should be included in the ICF? -
, CCRP Practice Questions(Latest Exam
2024
correct answers✅Wording indicating that there is no
expected benefit should be included.
A research subject's responsibilities for study
participation should be described in the: - correct
answers✅ICF
New safety information has become available from the
Sponsor about the IP being used in a clinical trial. The
Investigator must: - correct answers✅submit a revised
ICF to the IRB/IEC noting the new safety information.
A medical student is approached by a faculty member for
possible participation in a cricothyroidotomy simulation
research study. Which of the following increases risk to
the subject? - correct answers✅Consenting in the
presence of figure of authority
What would be the first priority for an investigator when a
subject wishes to withdraw prematurely from the trial? -
correct answers✅Try to obtain the subject's reason for
withdrawal.
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
