GOOD CLINICAL PRACTICE COMPREHENSIVE
SCRIPT 2026 FULL QUESTIONS CORRECT
ANSWERS
◉ In terms of explaining the probability of assignment to trial arms
in consent forms, which is true?
A) ICH notes that it should be included, but does not specify how the
information should be presented.
B) FDA requires the probability to be expressed as a percentage
chance.
C) Neither FDA nor ICH require statements about the probability for
random assignment to each treatment arm or the use of a placebo
arm.
D) The probability of assignment should always be stated as being
"like the flip of a coin" because subjects can understand that
example. Answer: A
◉ What is the status of ICH in U.S.?
A) It is a FDA guidance.
B) It has no status.
C) It is a federal statute (law).
D) It is a regulation codified at 21 CFR. Answer:
,◉ Per federal law, clinical trials may require the submission of an
Investigational New Drug (IND) application or Investigational
Device Exemption (IDE). The U.S. _______________________________ has
regulations in place for determining whether an IND or IDE is
required. Answer: Food and Drug Administration (FDA)
◉ T/F
Physicians are not allowed to use products for an indication not
listed in a the approved labeling ("off label"). Answer: F; however,
the physician has the responsibility to be well informed about the
product and to base the proposed use on scientific rationale and
medical evidence.
◉ ________________________ means an individual who both initiates and
conducts the clinical investigation and under whose immediate
direction the investigational drug or device is being administered,
used, or dispensed. Answer: Sponsor-Investigator
◉ Form _________________ is a contractual agreement between the
sponsor and FDA. Answer: FDA 1571
◉ An investigator who applies for an IND for a study and is acting as
the study sponsor must comply with the requirements of which of
the following:
A) Both the sponsor's and investigator's responsibilities
, B) The sponsor's responsibilities only
C) The investigator's responsibilities only Answer: A. In this
circumstance, the investigator also has the responsibilities of a
sponsor.
◉ According to ICH E6 Section 5.18, the purposes of trial_____________
are to verify that:
The rights and well-being of human subjects are protected.
The reported trial data are accurate, complete and verifiable from
source documents.
The conduct of the trial is in compliance with the currently approved
protocol/amendment(s), with GCP, and with applicable regulatory
requirements. Answer: monitoring
◉ Who is responsible for making the initial risk determination for a
device being used in a study? Answer: The sponsor-investigator.
◉ 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?
A) Adverse Event Summary Report, but only from unblinded
portions of studies ("open-label IND safety report")
B) IND renewal application
C) IND report
SCRIPT 2026 FULL QUESTIONS CORRECT
ANSWERS
◉ In terms of explaining the probability of assignment to trial arms
in consent forms, which is true?
A) ICH notes that it should be included, but does not specify how the
information should be presented.
B) FDA requires the probability to be expressed as a percentage
chance.
C) Neither FDA nor ICH require statements about the probability for
random assignment to each treatment arm or the use of a placebo
arm.
D) The probability of assignment should always be stated as being
"like the flip of a coin" because subjects can understand that
example. Answer: A
◉ What is the status of ICH in U.S.?
A) It is a FDA guidance.
B) It has no status.
C) It is a federal statute (law).
D) It is a regulation codified at 21 CFR. Answer:
,◉ Per federal law, clinical trials may require the submission of an
Investigational New Drug (IND) application or Investigational
Device Exemption (IDE). The U.S. _______________________________ has
regulations in place for determining whether an IND or IDE is
required. Answer: Food and Drug Administration (FDA)
◉ T/F
Physicians are not allowed to use products for an indication not
listed in a the approved labeling ("off label"). Answer: F; however,
the physician has the responsibility to be well informed about the
product and to base the proposed use on scientific rationale and
medical evidence.
◉ ________________________ means an individual who both initiates and
conducts the clinical investigation and under whose immediate
direction the investigational drug or device is being administered,
used, or dispensed. Answer: Sponsor-Investigator
◉ Form _________________ is a contractual agreement between the
sponsor and FDA. Answer: FDA 1571
◉ An investigator who applies for an IND for a study and is acting as
the study sponsor must comply with the requirements of which of
the following:
A) Both the sponsor's and investigator's responsibilities
, B) The sponsor's responsibilities only
C) The investigator's responsibilities only Answer: A. In this
circumstance, the investigator also has the responsibilities of a
sponsor.
◉ According to ICH E6 Section 5.18, the purposes of trial_____________
are to verify that:
The rights and well-being of human subjects are protected.
The reported trial data are accurate, complete and verifiable from
source documents.
The conduct of the trial is in compliance with the currently approved
protocol/amendment(s), with GCP, and with applicable regulatory
requirements. Answer: monitoring
◉ Who is responsible for making the initial risk determination for a
device being used in a study? Answer: The sponsor-investigator.
◉ 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?
A) Adverse Event Summary Report, but only from unblinded
portions of studies ("open-label IND safety report")
B) IND renewal application
C) IND report
