ACRP CP FINAL EXAM LATEST 2023 REAL
EXAM 150 QUESTIONS AND CORRECT
ANSWERS|AGRADE
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 informatiom 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
Phase I - ANSWER- The clinical trial phase that focuses on safety and human
pharmacology in healthy volunteers
Who is ultimately responsible for all aspects of the research conducted at a site? -
ANSWER- Principal investigator
Define GCP - ANSWER- An international quality standard that is provided by
ICH E6(R2) describing safety, accuracy of trials and credibility of data
What event resulted in the Nuremburg Cod of 1949 - ANSWER- Nazi Medical
Experiments
EXAM 150 QUESTIONS AND CORRECT
ANSWERS|AGRADE
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 informatiom 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
Phase I - ANSWER- The clinical trial phase that focuses on safety and human
pharmacology in healthy volunteers
Who is ultimately responsible for all aspects of the research conducted at a site? -
ANSWER- Principal investigator
Define GCP - ANSWER- An international quality standard that is provided by
ICH E6(R2) describing safety, accuracy of trials and credibility of data
What event resulted in the Nuremburg Cod of 1949 - ANSWER- Nazi Medical
Experiments
