GOOD CLINICAL PRACTICE STUDY GUIDE 2026 EXAM
QUESTIONS AND ANSWERS GRADED 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. - ✔✔
✔✔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. - ✔✔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"). - ✔✔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. - ✔✔Sponsor-Investigator
✔✔Form _________________ is a contractual agreement between the sponsor and
FDA. - ✔✔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 - ✔✔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. -
✔✔monitoring
✔✔Who is responsible for making the initial risk determination for a device being used
in a study? - ✔✔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
D) Marketing plan (that is, annual updated projection of sales and profits) - ✔✔C
✔✔Which of the following is an acceptable criterion for determining that a study of an
approved drug does not require an IND?
A) The study involves a route of administration that significantly increases the risks to
the patient.
B) The study intends to invoke an exception from informed consent.
C) The study is not intended to be reported to FDA to support a new indication or
support a labeling change.
D) The study intends to involve more than one hundred (100) patients in a study. - ✔✔C
✔✔_____________________ is a compilation of the clinical and nonclinical data on the
investigational product and serves as a resource for investigators, Institutional Review
Boards/Independent Ethics Committees (IRBs/IECs) during the conduct of a clinical
trial. - ✔✔Investigator's Brochure (IB)
✔✔the PI of a study has a daughter, who is married and lives with her husband, who is
a sales representative for the sponsor of that study. His daughter received $132,000
from the sponsor during the past twelve months. Must Dr. Thompson disclose his
daughter's income? - ✔✔No. Investigators must report their own income and financial
interests as well as income and financial interests of their spouse and each dependent
child. The PI's daughter is not a "dependent child."
✔✔Which party submits the completed, signed Form FDA 1572 to the FDA?
A) Sponsor
B) Study monitor
C) IRB
D) Investigator - ✔✔A
✔✔Must the investigator be a physician - ✔✔The regulations do not require that the
investigator be a physician. Sponsors are required to select only investigators qualified
by training and experience as appropriate experts to investigate the drug
✔✔There are two instances when it is necessary for an investigator to complete and
sign a new 1572: - ✔✔when an investigator is participating in a new protocol that has
been added to the IND and when a new investigator is added to the study (21 CFR
312.53(c)).
QUESTIONS AND ANSWERS GRADED 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. - ✔✔
✔✔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. - ✔✔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"). - ✔✔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. - ✔✔Sponsor-Investigator
✔✔Form _________________ is a contractual agreement between the sponsor and
FDA. - ✔✔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 - ✔✔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. -
✔✔monitoring
✔✔Who is responsible for making the initial risk determination for a device being used
in a study? - ✔✔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
D) Marketing plan (that is, annual updated projection of sales and profits) - ✔✔C
✔✔Which of the following is an acceptable criterion for determining that a study of an
approved drug does not require an IND?
A) The study involves a route of administration that significantly increases the risks to
the patient.
B) The study intends to invoke an exception from informed consent.
C) The study is not intended to be reported to FDA to support a new indication or
support a labeling change.
D) The study intends to involve more than one hundred (100) patients in a study. - ✔✔C
✔✔_____________________ is a compilation of the clinical and nonclinical data on the
investigational product and serves as a resource for investigators, Institutional Review
Boards/Independent Ethics Committees (IRBs/IECs) during the conduct of a clinical
trial. - ✔✔Investigator's Brochure (IB)
✔✔the PI of a study has a daughter, who is married and lives with her husband, who is
a sales representative for the sponsor of that study. His daughter received $132,000
from the sponsor during the past twelve months. Must Dr. Thompson disclose his
daughter's income? - ✔✔No. Investigators must report their own income and financial
interests as well as income and financial interests of their spouse and each dependent
child. The PI's daughter is not a "dependent child."
✔✔Which party submits the completed, signed Form FDA 1572 to the FDA?
A) Sponsor
B) Study monitor
C) IRB
D) Investigator - ✔✔A
✔✔Must the investigator be a physician - ✔✔The regulations do not require that the
investigator be a physician. Sponsors are required to select only investigators qualified
by training and experience as appropriate experts to investigate the drug
✔✔There are two instances when it is necessary for an investigator to complete and
sign a new 1572: - ✔✔when an investigator is participating in a new protocol that has
been added to the IND and when a new investigator is added to the study (21 CFR
312.53(c)).
