ACRP CP FINAL EXAM LATEST EXAM WITH 200
VERIFIED QUESTIONS AND CORRECT
SOLUTIONS |THE LATEST EDITION.
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
VERIFIED QUESTIONS AND CORRECT
SOLUTIONS |THE LATEST EDITION.
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
