CRS-Exam 2 UPDATED Study Guide
ACTUAL QUESTIONS AND CORRECT
ANSWERS
All individuals involved in clinical research have a role in: - CORRECT
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? -
CORRECT ANSWER Quality Assurance Auditor
In which field are product development timelines typically shorter? - CORRECT
ANSWER Medical Device
Who has the responsibility to protect human subjects? - CORRECT ANSWER All
people involved in clinical research
It is OK for a sponsor to transfer some obligations to a contract research organization
verbally - CORRECT 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? - CORRECT
ANSWER Curriculum Vitae (CV)
What should a sponsor do when they discover a PI is not complying with the general
investigational plan? - CORRECT ANSWER Promptly secure compliance or
discontinue shipments of investigational new drug
FDA is allowed to inspect the sponsor or the site at any reasonable time - CORRECT
ANSWER True
, For how long must the investigational site retain records if the drug under study is not
approved for the study indication? - CORRECT 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? -
CORRECT 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. - CORRECT
ANSWER False
which of the following should be included on the monitoring visit report? - CORRECT
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? - CORRECT 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? -
CORRECT ANSWER 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? -
CORRECT 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? - CORRECT
ANSWER verification of informed consent
What is the next step the sponsor should take after identifying critical data and processes? -
CORRECT ANSWER Conduct a risk assessment to identify potential risks that may
affect the collection of critical data
ACTUAL QUESTIONS AND CORRECT
ANSWERS
All individuals involved in clinical research have a role in: - CORRECT
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? -
CORRECT ANSWER Quality Assurance Auditor
In which field are product development timelines typically shorter? - CORRECT
ANSWER Medical Device
Who has the responsibility to protect human subjects? - CORRECT ANSWER All
people involved in clinical research
It is OK for a sponsor to transfer some obligations to a contract research organization
verbally - CORRECT 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? - CORRECT
ANSWER Curriculum Vitae (CV)
What should a sponsor do when they discover a PI is not complying with the general
investigational plan? - CORRECT ANSWER Promptly secure compliance or
discontinue shipments of investigational new drug
FDA is allowed to inspect the sponsor or the site at any reasonable time - CORRECT
ANSWER True
, For how long must the investigational site retain records if the drug under study is not
approved for the study indication? - CORRECT 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? -
CORRECT 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. - CORRECT
ANSWER False
which of the following should be included on the monitoring visit report? - CORRECT
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? - CORRECT 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? -
CORRECT ANSWER 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? -
CORRECT 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? - CORRECT
ANSWER verification of informed consent
What is the next step the sponsor should take after identifying critical data and processes? -
CORRECT ANSWER Conduct a risk assessment to identify potential risks that may
affect the collection of critical data
