ACRP CP FINAL EXAM QUESTIONS WITH COMPLETE
SOLUTIONS 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
SOLUTIONS 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
