1|Page
CITI TRAINING - GOOD CLINICAL PRACTICE LATEST 2025 ACTUAL
EXAM WITH COMPLETE QUESTIONS AND CORRECT DETAILED
ANSWERS (100% VERIFIED ANSWERS) |ALREADY GRADED A+|
||PROFESSOR VERIFIED|| ||BRANDNEW!!!||
Which of the following is an acceptable criterion for determining
that a study of an approved drug does not require an IND? -
ANSWER-The study is not intended to be reported to FDA to
support a new indication or support a labeling change.
When the sponsor-investigator holds the IND for an
investigational drug he or she is responsible for annual reporting
of which one of the following to FDA? - ANSWER-IND report
Who is responsible for making the initial risk determination for a
device being used in a study? - ANSWER-The sponsor-
investigator
When must the investigator update the IRB about the progress of
a trial? - ANSWER-During the conduct of the study and at
termination
, 2|Page
Identify which party is responsible for reporting directly to the FDA
the investigator's financial interests with the sponsor: - ANSWER-
The sponsor
Which of the following is an investigator's commitment to the
sponsor? - ANSWER-Submit a new Form FDA 1572 to sponsor
as needed
The investigator must report adverse events to the: - ANSWER-
Sponsor.
Form FDA 1572, Statement of Investigator, is legally binding
between the Investigator and the: - ANSWER-FDA.
Which of the following is an important component of drug
accountability? - ANSWER-Drug shipping and disposition records
Who has ultimate responsibility for an investigational product? -
ANSWER-Investigator
CITI TRAINING - GOOD CLINICAL PRACTICE LATEST 2025 ACTUAL
EXAM WITH COMPLETE QUESTIONS AND CORRECT DETAILED
ANSWERS (100% VERIFIED ANSWERS) |ALREADY GRADED A+|
||PROFESSOR VERIFIED|| ||BRANDNEW!!!||
Which of the following is an acceptable criterion for determining
that a study of an approved drug does not require an IND? -
ANSWER-The study is not intended to be reported to FDA to
support a new indication or support a labeling change.
When the sponsor-investigator holds the IND for an
investigational drug he or she is responsible for annual reporting
of which one of the following to FDA? - ANSWER-IND report
Who is responsible for making the initial risk determination for a
device being used in a study? - ANSWER-The sponsor-
investigator
When must the investigator update the IRB about the progress of
a trial? - ANSWER-During the conduct of the study and at
termination
, 2|Page
Identify which party is responsible for reporting directly to the FDA
the investigator's financial interests with the sponsor: - ANSWER-
The sponsor
Which of the following is an investigator's commitment to the
sponsor? - ANSWER-Submit a new Form FDA 1572 to sponsor
as needed
The investigator must report adverse events to the: - ANSWER-
Sponsor.
Form FDA 1572, Statement of Investigator, is legally binding
between the Investigator and the: - ANSWER-FDA.
Which of the following is an important component of drug
accountability? - ANSWER-Drug shipping and disposition records
Who has ultimate responsibility for an investigational product? -
ANSWER-Investigator
