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1. According to ICH E6, an inspection is defined as: - correct
answer - An official review of documents, facilities, records, and
any other resources related to a clinical trial.
An inspection is defined as the act by a regulatory authority
of conducting an official review of documents, facilities,
records, and any other resources related to a clinical trial. A
systematic and independent examination of trial-related
activities and documents is "an audit" and the act of
overseeing the progress of a clinical trial is "monitoring."
2. According to the FDA and ICH, which entity has the
responsibility for monitoring a clinical trial? - correct answer -
According to FDA regulations and ICH E6 Section 5.18.7, the
sponsor is responsible for developing a monitoring plan that is
specific to the human subject protection and data integrity risks
of the trial.
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3. When should the sponsor-monitor conduct the most detailed
review of the study protocol with the site's study staff? - correct
answer - Site initiation visit
The site initiation visit focuses on in-depth training of the
study staff which includes detailed review of the study
protocol requirements. The site's ability to conduct the type
of study proposed is assessed primarily during the prestudy
visit.
4. Which of the following is required at a prestudy site visit? -
correct answer - Evaluation of the site's capacity to conduct the
study
The prestudy visit is an assessment of the site's ability to
conduct the study. Regulatory documents would not be
generated until the site is accepted as an investigative site.
5. The FDA requires retention of investigational drug study
records for: - correct answer - At least two (2) years after the
investigational drug's approval by the FDA
The FDA requires that sites maintain study-related records
for at least two (2) years after the drug has been granted
marketing approval in the U.S. for the indication tested in
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the study or, if no application will be filed or if the
application is not for the indication, for at least two (2) years
after the investigation is terminated and the FDA is notified.
For devices, the investigator or sponsor shall maintain the
records for a period of two (2) years from the date on which
the investigation is terminated or completed, or the date
that the records are no longer required for purposes of
supporting a premarket approval (PMA) or a notice of
completion of a product development protocol.
6. All unused investigational agents are expected to be returned
to the sponsor at the: - correct answer - Termination site visit
At the end of the study, final disposition of all the remaining
investigational agents at the site must take place. The
investigational agents will be shipped back to the sponsor
unless the sponsor allows an alternative disposition.
7. Which monitoring visit would not include an inventory of
investigational agents? - correct answer - Prestudy site visit
At the prestudy visit, the site has not yet been chosen for
participation in the study and would not have received any
investigational agents.
1. According to ICH E6, an inspection is defined as: - correct
answer - An official review of documents, facilities, records, and
any other resources related to a clinical trial.
An inspection is defined as the act by a regulatory authority
of conducting an official review of documents, facilities,
records, and any other resources related to a clinical trial. A
systematic and independent examination of trial-related
activities and documents is "an audit" and the act of
overseeing the progress of a clinical trial is "monitoring."
2. According to the FDA and ICH, which entity has the
responsibility for monitoring a clinical trial? - correct answer -
According to FDA regulations and ICH E6 Section 5.18.7, the
sponsor is responsible for developing a monitoring plan that is
specific to the human subject protection and data integrity risks
of the trial.
, Page | 2
3. When should the sponsor-monitor conduct the most detailed
review of the study protocol with the site's study staff? - correct
answer - Site initiation visit
The site initiation visit focuses on in-depth training of the
study staff which includes detailed review of the study
protocol requirements. The site's ability to conduct the type
of study proposed is assessed primarily during the prestudy
visit.
4. Which of the following is required at a prestudy site visit? -
correct answer - Evaluation of the site's capacity to conduct the
study
The prestudy visit is an assessment of the site's ability to
conduct the study. Regulatory documents would not be
generated until the site is accepted as an investigative site.
5. The FDA requires retention of investigational drug study
records for: - correct answer - At least two (2) years after the
investigational drug's approval by the FDA
The FDA requires that sites maintain study-related records
for at least two (2) years after the drug has been granted
marketing approval in the U.S. for the indication tested in
, Page | 3
m m m m m
the study or, if no application will be filed or if the
application is not for the indication, for at least two (2) years
after the investigation is terminated and the FDA is notified.
For devices, the investigator or sponsor shall maintain the
records for a period of two (2) years from the date on which
the investigation is terminated or completed, or the date
that the records are no longer required for purposes of
supporting a premarket approval (PMA) or a notice of
completion of a product development protocol.
6. All unused investigational agents are expected to be returned
to the sponsor at the: - correct answer - Termination site visit
At the end of the study, final disposition of all the remaining
investigational agents at the site must take place. The
investigational agents will be shipped back to the sponsor
unless the sponsor allows an alternative disposition.
7. Which monitoring visit would not include an inventory of
investigational agents? - correct answer - Prestudy site visit
At the prestudy visit, the site has not yet been chosen for
participation in the study and would not have received any
investigational agents.
