Clinical research exam 2 Questions with Correct
Answers
Which of the following should be used to determine the extent and
nature of monitoring?
A. Purpose, drug type, and number of subjects
B. Purpose, complexity, and endpoints of study
C. Number of subjects, complexity, and length of study
D. Complexity, drug type, and endpoints of study Correct Answer-C.
Number of subjects, complexity, and length of study
True or False: the clinical trial monitor must ensure that they are
informing the FDA of any CRF entry error they find during the course of
the clinical trial. Correct Answer-False
Which of the following should be included on the monitoring visit
report?
A. Date and time of follow up monitoring visit
B. Number of subjects who had 100% source data verification during the
visit
C. Name of study subjects whose informed consent were verified during
the visit
D. Name of principal investigator at site Correct Answer-D. Name of
principal investigator at site
,What is one reason the FDA has encouraged sponsors to adopt a risk-
based approach to clinical trial monitoring?
A. FDA believes that risk-based monitoring will improve sponsor
oversight at clinical trials
B. FDA sees risk-based monitoring as a way to review less information
during review of marketing applications
C. FDA believes that risk-based monitoring will improve site
compliance as it requires the CRAs to do more data verification
D. Risk-based monitoring allows CRAs to spend less time reviewing
subject data and more time reviewing data queries which will make
monitoring clinical trials more efficient Correct Answer-A. FDA
believes that risk-based monitoring will improve sponsor oversight at
clinical trials
What activity does FDA believe can be done better through the use of
remote monitoring?
A. Conducting site initiation visits to determine the site is ready to start
enrolling study subjects
B. Verifying clinical trial site facilities and laboratories that will be
processing samples and uploading data electronically to subject records
C. Analyzing site performance metrics and clinical data to identify trial
sites that have poor performance or potential noncompliance
D. Performing investigational product accountability on medical devices
that are distributed to patients with use of electronic systems Correct
,Answer-C. Analyzing site performance metrics and clinical data to
identify trial sites that have poor performance or potential
noncompliance
What should the sponsor consider during the identification of critical
data and processes?
A. Method in which source data will be collected
B. Electronic system being used to collect subject data
C. Quantity and type of source data that needs to be verified
D. Number of study subjects enrolled in trial Correct Answer-C.
Quantity and type of source data that needs to be verified
When the sponsor is identifying critical data to determine the best
approach to monitoring, which of the following would be considered
critical?
A. Ease of use of electronic system where case report forms are
completed
B. Verification of informed consent
C. How many CRAs are assigned to a project
D. Type of blinding being used in the study Correct Answer-B.
Verification of informed consent
What is the next step the sponsor should take after identifying critical
data and processes?
, A. Conduct a risk assessment to identify potential risks that may affect
the collection of critical data
B. Finalize the clinical monitoring plan
C. Review their approach to monitoring with a representative of the
FDA
D. Determine how many CRAs will be needed in order to effectively
monitor the conduct of the trial with the proposed monitoring strategy
Correct Answer-A. Conduct a risk assessment to identify potential risks
that may affect the collection of critical data
How does sponsor oversight help protect clinical trial subjects? Correct
Answer-By design, the study protocol has measures to ensure subject
safety. When the sponsor oversees a site's adherence to the study
protocol, they are verifying that the site is following all of the safety
measures that are contained within the protocol.
How does the monitor assist the sponsor? Correct Answer-The monitor
is the principal communication link between the sponsor and the
investigator. They confirm that the site is following the study protocol,
provide additional training support as needed, and ensure that the study
is on track with the original timeline.
How does a monitor oversee a sight? Correct Answer-Monitors ensure
that good documentation practices, good clinical practices, applicable
regulations, and the study protocol are being followed at the
investigational site.
Answers
Which of the following should be used to determine the extent and
nature of monitoring?
A. Purpose, drug type, and number of subjects
B. Purpose, complexity, and endpoints of study
C. Number of subjects, complexity, and length of study
D. Complexity, drug type, and endpoints of study Correct Answer-C.
Number of subjects, complexity, and length of study
True or False: the clinical trial monitor must ensure that they are
informing the FDA of any CRF entry error they find during the course of
the clinical trial. Correct Answer-False
Which of the following should be included on the monitoring visit
report?
A. Date and time of follow up monitoring visit
B. Number of subjects who had 100% source data verification during the
visit
C. Name of study subjects whose informed consent were verified during
the visit
D. Name of principal investigator at site Correct Answer-D. Name of
principal investigator at site
,What is one reason the FDA has encouraged sponsors to adopt a risk-
based approach to clinical trial monitoring?
A. FDA believes that risk-based monitoring will improve sponsor
oversight at clinical trials
B. FDA sees risk-based monitoring as a way to review less information
during review of marketing applications
C. FDA believes that risk-based monitoring will improve site
compliance as it requires the CRAs to do more data verification
D. Risk-based monitoring allows CRAs to spend less time reviewing
subject data and more time reviewing data queries which will make
monitoring clinical trials more efficient Correct Answer-A. FDA
believes that risk-based monitoring will improve sponsor oversight at
clinical trials
What activity does FDA believe can be done better through the use of
remote monitoring?
A. Conducting site initiation visits to determine the site is ready to start
enrolling study subjects
B. Verifying clinical trial site facilities and laboratories that will be
processing samples and uploading data electronically to subject records
C. Analyzing site performance metrics and clinical data to identify trial
sites that have poor performance or potential noncompliance
D. Performing investigational product accountability on medical devices
that are distributed to patients with use of electronic systems Correct
,Answer-C. Analyzing site performance metrics and clinical data to
identify trial sites that have poor performance or potential
noncompliance
What should the sponsor consider during the identification of critical
data and processes?
A. Method in which source data will be collected
B. Electronic system being used to collect subject data
C. Quantity and type of source data that needs to be verified
D. Number of study subjects enrolled in trial Correct Answer-C.
Quantity and type of source data that needs to be verified
When the sponsor is identifying critical data to determine the best
approach to monitoring, which of the following would be considered
critical?
A. Ease of use of electronic system where case report forms are
completed
B. Verification of informed consent
C. How many CRAs are assigned to a project
D. Type of blinding being used in the study Correct Answer-B.
Verification of informed consent
What is the next step the sponsor should take after identifying critical
data and processes?
, A. Conduct a risk assessment to identify potential risks that may affect
the collection of critical data
B. Finalize the clinical monitoring plan
C. Review their approach to monitoring with a representative of the
FDA
D. Determine how many CRAs will be needed in order to effectively
monitor the conduct of the trial with the proposed monitoring strategy
Correct Answer-A. Conduct a risk assessment to identify potential risks
that may affect the collection of critical data
How does sponsor oversight help protect clinical trial subjects? Correct
Answer-By design, the study protocol has measures to ensure subject
safety. When the sponsor oversees a site's adherence to the study
protocol, they are verifying that the site is following all of the safety
measures that are contained within the protocol.
How does the monitor assist the sponsor? Correct Answer-The monitor
is the principal communication link between the sponsor and the
investigator. They confirm that the site is following the study protocol,
provide additional training support as needed, and ensure that the study
is on track with the original timeline.
How does a monitor oversee a sight? Correct Answer-Monitors ensure
that good documentation practices, good clinical practices, applicable
regulations, and the study protocol are being followed at the
investigational site.
