ACRP CP FINAL EXAM LATEST 2023 REAL
EXAM 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 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
What event resulted in the Nuremburg Cod of 1949 - ANSWER>>Nazi Medical Experiments
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
EXAM 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 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
What event resulted in the Nuremburg Cod of 1949 - ANSWER>>Nazi Medical Experiments
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
