CRS Exam 2 Questions and Answers Latest Update 2025 Graded A+
All individuals involved in clinical research have a role in: - Answers 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? - Answers Quality
Assurance Auditor
In which field are product development timelines typically shorter? - Answers Medical Device
Who has the responsibility to protect human subjects? - Answers All people involved in clinical research
It is OK for a sponsor to transfer some obligations to a contract research organization verbally - Answers
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? - Answers Curriculum Vitae (CV)
What should a sponsor do when they discover a PI is not complying with the general investigational
plan? - Answers Promptly secure compliance or discontinue shipments of investigational new drug
FDA is allowed to inspect the sponsor or the site at any reasonable time - Answers True
For how long must the investigational site retain records if the drug under study is not approved for the
study indication? - Answers 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? - Answers 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. - Answers False
which of the following should be included on the monitoring visit report? - Answers 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? - Answers 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? - Answers
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? - Answers 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? - Answers verification of informed consent
What is the next step the sponsor should take after identifying critical data and processes? - Answers
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? - Answers 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? - Answers 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 - Answers False
For how long should the IRB/IEC retain all relevant records? - Answers 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)? - Answers A physician from the neurology department, a first grade teacher, two nurses
from the emergency department, and a private practice cardiologist
Which of the following are true regarding payments to subjects - Answers The IRB must review the
method of payment
Payments must be prorated
The IRB must review the amount of payment
Payments must be set forth in the informed consent form
How often must the IRB conduct continuing review of each ongoing trial? - Answers at least once per
year
What are the most important considerations to be taken in clinical trials? - Answers Rights of the subject
Well-being of the subject
Safety of the subject
This person is always responsible for the medical care given to, and the medical decisions made on
behalf of subjects - Answers A qualified physician
Why does Dr. Beecher state that he is calling attention to ethical errors through his article? - Answers
Pressures on young physicians to prove themselves as investigators
All individuals involved in clinical research have a role in: - Answers 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? - Answers Quality
Assurance Auditor
In which field are product development timelines typically shorter? - Answers Medical Device
Who has the responsibility to protect human subjects? - Answers All people involved in clinical research
It is OK for a sponsor to transfer some obligations to a contract research organization verbally - Answers
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? - Answers Curriculum Vitae (CV)
What should a sponsor do when they discover a PI is not complying with the general investigational
plan? - Answers Promptly secure compliance or discontinue shipments of investigational new drug
FDA is allowed to inspect the sponsor or the site at any reasonable time - Answers True
For how long must the investigational site retain records if the drug under study is not approved for the
study indication? - Answers 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? - Answers 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. - Answers False
which of the following should be included on the monitoring visit report? - Answers 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? - Answers 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? - Answers
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? - Answers 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? - Answers verification of informed consent
What is the next step the sponsor should take after identifying critical data and processes? - Answers
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? - Answers 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? - Answers 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 - Answers False
For how long should the IRB/IEC retain all relevant records? - Answers 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)? - Answers A physician from the neurology department, a first grade teacher, two nurses
from the emergency department, and a private practice cardiologist
Which of the following are true regarding payments to subjects - Answers The IRB must review the
method of payment
Payments must be prorated
The IRB must review the amount of payment
Payments must be set forth in the informed consent form
How often must the IRB conduct continuing review of each ongoing trial? - Answers at least once per
year
What are the most important considerations to be taken in clinical trials? - Answers Rights of the subject
Well-being of the subject
Safety of the subject
This person is always responsible for the medical care given to, and the medical decisions made on
behalf of subjects - Answers A qualified physician
Why does Dr. Beecher state that he is calling attention to ethical errors through his article? - Answers
Pressures on young physicians to prove themselves as investigators
