©SOPHIABENNETT@2024-2025 Saturday, August 24, 2024 8:52 AM
CRS exam 2 Practice Questions and Answers (100% Pass)
All individuals involved in clinical research have a role in: - Answer✔️✔️-
Helping to develop safe and effective therapies while ensuring the rights,
safety, and welfare of the subjects have been protected
According to the article, which non entry-level clinical research role needs
to be able to point out the deficiencies related to the work of others and
hence must not be adverse to conflict? - Answer✔️✔️-Quality Assurance
Auditor
In which field are product development timelines typically shorter? -
Answer✔️✔️-Medical Device
Who has the responsibility to protect human subjects? - Answer✔️✔️-All
people involved in clinical research
It is OK for a sponsor to transfer some obligations to a contract research
organization verbally - Answer✔️✔️-False
Which document demonstrates that the PI has the education, training, and
experience to be an expert in the clinical investigation of the drug under
investigation? - Answer✔️✔️-Curriculum Vitae (CV)
What should a sponsor do when they discover a PI is not complying with
the general investigational plan? - Answer✔️✔️-Promptly secure compliance
or discontinue shipments of investigational new drug
1
, ©SOPHIABENNETT@2024-2025 Saturday, August 24, 2024 8:52 AM
FDA is allowed to inspect the sponsor or the site at any reasonable time -
Answer✔️✔️-True
For how long must the investigational site retain records if the drug under
study is not approved for the study indication? - Answer✔️✔️-2 years after
the investigation is discontinued and FDA is notified
which of the following should be used to determine the extent and nature
of monitoring? - Answer✔️✔️-The purpose, complexity, and endpoints of
the 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 clinical trial
monitoring. - Answer✔️✔️-False
which of the following should be included on the monitoring visit report? -
Answer✔️✔️-Name of the PI at the site
What is one reason that FDA has encouraged sponsors to adopt a risk-
based approach to clinical trial monitoring? - Answer✔️✔️-FDA believes that
risk-based monitoring will improve sponsor oversight of clinical trials
Which activity does FDA believe can be done better through the use of
remote monitoring? - Answer✔️✔️-Analyzing site performance metrics, and
clinical data to identify trial sites that have poor performance or potential
noncompliance
2
, ©SOPHIABENNETT@2024-2025 Saturday, August 24, 2024 8:52 AM
What should the sponsor consider during the identification of critical data
and processes? - Answer✔️✔️-The 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? - Answer✔️✔️-verification of informed consent
What is the next step the sponsor should take after identifying critical data
and processes? - Answer✔️✔️-Conduct a risk assessment to identify
potential risks that may affect the collection of critical data
Which of the following should be considered when developing a
monitoring plan? - Answer✔️✔️-Complexity of the study design
Types of study endpoints
If the sponsor of a clinical trial is planning on delegating the tasks of
monitoring the clinical trial to a contract research organization, what do
FDA regulations require that they do? - Answer✔️✔️-Have a written transfer
of obligations from the sponsor to the CRO
True of False: adverse drug reactions which are serious and expected must
be reported promptly to the IRB by the investigator - Answer✔️✔️-False
For how long should the IRB/IEC retain all relevant records? - Answer✔️✔️-
For at least 3 years after completion of the trial
Which of the following would be an appropriate IRB/IEC roster at a
Helping Hands Hospital (a fictional institution)? - Answer✔️✔️-A physician
3
CRS exam 2 Practice Questions and Answers (100% Pass)
All individuals involved in clinical research have a role in: - Answer✔️✔️-
Helping to develop safe and effective therapies while ensuring the rights,
safety, and welfare of the subjects have been protected
According to the article, which non entry-level clinical research role needs
to be able to point out the deficiencies related to the work of others and
hence must not be adverse to conflict? - Answer✔️✔️-Quality Assurance
Auditor
In which field are product development timelines typically shorter? -
Answer✔️✔️-Medical Device
Who has the responsibility to protect human subjects? - Answer✔️✔️-All
people involved in clinical research
It is OK for a sponsor to transfer some obligations to a contract research
organization verbally - Answer✔️✔️-False
Which document demonstrates that the PI has the education, training, and
experience to be an expert in the clinical investigation of the drug under
investigation? - Answer✔️✔️-Curriculum Vitae (CV)
What should a sponsor do when they discover a PI is not complying with
the general investigational plan? - Answer✔️✔️-Promptly secure compliance
or discontinue shipments of investigational new drug
1
, ©SOPHIABENNETT@2024-2025 Saturday, August 24, 2024 8:52 AM
FDA is allowed to inspect the sponsor or the site at any reasonable time -
Answer✔️✔️-True
For how long must the investigational site retain records if the drug under
study is not approved for the study indication? - Answer✔️✔️-2 years after
the investigation is discontinued and FDA is notified
which of the following should be used to determine the extent and nature
of monitoring? - Answer✔️✔️-The purpose, complexity, and endpoints of
the 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 clinical trial
monitoring. - Answer✔️✔️-False
which of the following should be included on the monitoring visit report? -
Answer✔️✔️-Name of the PI at the site
What is one reason that FDA has encouraged sponsors to adopt a risk-
based approach to clinical trial monitoring? - Answer✔️✔️-FDA believes that
risk-based monitoring will improve sponsor oversight of clinical trials
Which activity does FDA believe can be done better through the use of
remote monitoring? - Answer✔️✔️-Analyzing site performance metrics, and
clinical data to identify trial sites that have poor performance or potential
noncompliance
2
, ©SOPHIABENNETT@2024-2025 Saturday, August 24, 2024 8:52 AM
What should the sponsor consider during the identification of critical data
and processes? - Answer✔️✔️-The 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? - Answer✔️✔️-verification of informed consent
What is the next step the sponsor should take after identifying critical data
and processes? - Answer✔️✔️-Conduct a risk assessment to identify
potential risks that may affect the collection of critical data
Which of the following should be considered when developing a
monitoring plan? - Answer✔️✔️-Complexity of the study design
Types of study endpoints
If the sponsor of a clinical trial is planning on delegating the tasks of
monitoring the clinical trial to a contract research organization, what do
FDA regulations require that they do? - Answer✔️✔️-Have a written transfer
of obligations from the sponsor to the CRO
True of False: adverse drug reactions which are serious and expected must
be reported promptly to the IRB by the investigator - Answer✔️✔️-False
For how long should the IRB/IEC retain all relevant records? - Answer✔️✔️-
For at least 3 years after completion of the trial
Which of the following would be an appropriate IRB/IEC roster at a
Helping Hands Hospital (a fictional institution)? - Answer✔️✔️-A physician
3
