GOOD CLINICAL PRACTICE TEST PAPER 2026
COMPLETE RESPONSES GRADED A+
◉ The FDA regulations allow subjects or the legally acceptable
representatives (LARs) to receive either a signed or unsigned copy.
Answer: Regarding subject receipt of a signed and dated copy of the
consent forms, which is true about FDA regulations?
◉ Identification of study risks to determine which may safely be
omitted from continual monitoring. Answer: The new ICH E6
integrated addendum (R2) requires sponsors to implement systems
to manage quality throughout all stages of the trial process. The
system should use a risk-based approach including which of the
following?
◉ Clearly disclose to subjects in the informed consent form that the
monitor, auditor, IRB/IEC, and the regulatory authorities may have
access to the subject's medical records Answer: ICH E6 has broader
requirements than FDA or HHS concerning confidentiality of
medical records and access by third parties. If investigators are
complying with ICH E6 guidelines, they must:
◉ It is a FDA guidance Answer: What is the legal status of ICH in
U.S.?
, ◉ The study is not intended to be reported to FDA to support a new
indication or support a labeling change. Answer: Which of the
following is an acceptable criterion for determining that a study of
an approved drug does not require an IND?
◉ IND report Answer: 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?
◉ The sponsor-investigator Answer: Who is responsible for making
the initial risk determination for a device being used in a study?
◉ During the conduct of the study and at termination Answer: When
must the investigator update the IRB about the progress of a trial?
◉ The sponsor Answer: Identify which party is responsible for
reporting directly to the FDA the investigator's financial interests
with the sponsor:
◉ Submit a new Form FDA 1572 to sponsor as needed Answer:
Which of the following is an investigator's commitment to the
sponsor?
◉ Sponsor. Answer: The investigator must report adverse events to
the:
COMPLETE RESPONSES GRADED A+
◉ The FDA regulations allow subjects or the legally acceptable
representatives (LARs) to receive either a signed or unsigned copy.
Answer: Regarding subject receipt of a signed and dated copy of the
consent forms, which is true about FDA regulations?
◉ Identification of study risks to determine which may safely be
omitted from continual monitoring. Answer: The new ICH E6
integrated addendum (R2) requires sponsors to implement systems
to manage quality throughout all stages of the trial process. The
system should use a risk-based approach including which of the
following?
◉ Clearly disclose to subjects in the informed consent form that the
monitor, auditor, IRB/IEC, and the regulatory authorities may have
access to the subject's medical records Answer: ICH E6 has broader
requirements than FDA or HHS concerning confidentiality of
medical records and access by third parties. If investigators are
complying with ICH E6 guidelines, they must:
◉ It is a FDA guidance Answer: What is the legal status of ICH in
U.S.?
, ◉ The study is not intended to be reported to FDA to support a new
indication or support a labeling change. Answer: Which of the
following is an acceptable criterion for determining that a study of
an approved drug does not require an IND?
◉ IND report Answer: 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?
◉ The sponsor-investigator Answer: Who is responsible for making
the initial risk determination for a device being used in a study?
◉ During the conduct of the study and at termination Answer: When
must the investigator update the IRB about the progress of a trial?
◉ The sponsor Answer: Identify which party is responsible for
reporting directly to the FDA the investigator's financial interests
with the sponsor:
◉ Submit a new Form FDA 1572 to sponsor as needed Answer:
Which of the following is an investigator's commitment to the
sponsor?
◉ Sponsor. Answer: The investigator must report adverse events to
the:
