GOOD CLINICAL PRACTICE CORE EXAM 2026 TEST
QUESTIONS AND ANSWERS GRADED A+
✔✔What is the status of ICH in U.S.? - ✔✔• It is a FDA guidance
* After the ICH E6 guideline was finalized, several countries adopted it as law. In the
United States, however, the FDA adopted the ICH E6 only as guidance. Therefore, the
ICH E6 guideline does not have the force of law in the United States and is not a
regulation. In the Federal Register notice, FDA stated that the ICH E6 guideline "does
not create or confer any rights for or on any person and does not operate to bind FDA or
the public. An alternative approach may be used if such approach satisfies the
requirements of the applicable statutes, regulations, or both" (HHS and FDA 1997,
25692). Therefore, compliance is voluntary, but as with any published FDA guidance,
compliance is considered part of good clinical practice.
✔✔Regarding subject receipt of a signed and dated copy of the consent forms, which is
true about FDA regulations? - ✔✔• The FDA regulations allow subjects or the legally
acceptable representatives (LARs) to receive either a signed or unsigned copy.
* The FDA regulations allow subjects to receive either a signed or unsigned copy. ICH
E6 Section 4.8.11 requires that the subject or the legally acceptable representative
(LAR) receive a copy of the signed and dated written informed consent form. The FDA
(1998) regulations allow subjects to receive either a signed or unsigned copy. To be in
compliance with ICH E6 guideline, the investigator should include a statement in the
consent form that the subject will receive a signed and dated copy of the consent form.
Persons obtaining consent must then ensure that this procedure is followed.
✔✔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
guideline, they must: - ✔✔• 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.
* ICH (2016) E6 Section 4.8.10(n) states that the informed consent should indicate that
"the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be
granted direct access to the subject's original medical records for verification of clinical
trial procedures and/or data, without violating the confidentiality of the subject, to the
extent permitted by the applicable laws and regulations and that, by signing a written
informed consent form, the subject or the subject's legally acceptable representative is
authorizing such access." The FDA regulations at 21 CFR 50.25(a)(5) (Protection of
Human Subjects 2016) state only that in seeking informed consent, the following
information shall be provided to each subject:. . . (5) A statement describing the extent,
if any, to which confidentiality of records identifying the subject will be maintained and
that notes the possibility that the Food and Drug Administration may inspect the
records. While it is true that data sent out of the U.S. loses certain federal protections,
this statement is not required. The possibility of hacking data is a risk that should be
, addressed in the study design and conduct. Non-disclosure forms are not required for
communications with primary care providers.
✔✔Which of the following is an acceptable criterion for determining that a study of an
approved drug does not require an IND? - ✔✔• The study is not intended to be reported
to FDA to support a new indication or support a labeling change.
* The number of subjects in a study is not a consideration for IND exemption. Any study
that significantly increases risk to subjects or invokes an exception from informed
consent for emergency research (21 CFR 50.24) does not meet one of the criterion for
an IND exemption. Investigations that are not intended to be reported to FDA do qualify
as meeting one of the six required conditions for an IND exemption.
✔✔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? - ✔✔• IND report
* The sponsor-investigator is required to keep the FDA updated through IND Safety
Reports, IND amendments, and annual IND reports. IND Safety Reports are filed
throughout the study, not just annually. There is no requirement for an annual
submission of an IND renewal application or marketing plan.
✔✔Who is responsible for making the initial risk determination for a device being used
in a study? - ✔✔• The sponsor-investigator.
* The sponsor-investigator is responsible for making the initial risk determination and
presenting it to the IRB. The FDA is available to help sponsor-investigators and IRBs in
making the risk determination. The drug manufacturer is not involved in the risk
determination for a sponsor-investigator study.
✔✔Identify which party is responsible for reporting directly to the FDA the investigator's
financial interests with the sponsor: - ✔✔• The sponsor
* The investigator provides the sponsor with a completed form for reporting financial
interests to the FDA. The sponsor is responsible for providing the FDA with this
information. This includes potential financial interests in the sponsor's company or
financial interests that might be influenced positively or negatively by the outcome of the
clinical investigation.
✔✔Which of the following is an investigator's commitment to the sponsor? - ✔✔• Submit
a new Form FDA 1572 to the sponsor as needed
* The investigator must submit a new Form FDA 1572 to the sponsor when an
investigator is participating in a new protocol that has been added to the IND or when a
new investigator is added to the study. The IRB, not the sponsor, provides ongoing
approval for study continuation at the site. The investigator submits the financial
QUESTIONS AND ANSWERS GRADED A+
✔✔What is the status of ICH in U.S.? - ✔✔• It is a FDA guidance
* After the ICH E6 guideline was finalized, several countries adopted it as law. In the
United States, however, the FDA adopted the ICH E6 only as guidance. Therefore, the
ICH E6 guideline does not have the force of law in the United States and is not a
regulation. In the Federal Register notice, FDA stated that the ICH E6 guideline "does
not create or confer any rights for or on any person and does not operate to bind FDA or
the public. An alternative approach may be used if such approach satisfies the
requirements of the applicable statutes, regulations, or both" (HHS and FDA 1997,
25692). Therefore, compliance is voluntary, but as with any published FDA guidance,
compliance is considered part of good clinical practice.
✔✔Regarding subject receipt of a signed and dated copy of the consent forms, which is
true about FDA regulations? - ✔✔• The FDA regulations allow subjects or the legally
acceptable representatives (LARs) to receive either a signed or unsigned copy.
* The FDA regulations allow subjects to receive either a signed or unsigned copy. ICH
E6 Section 4.8.11 requires that the subject or the legally acceptable representative
(LAR) receive a copy of the signed and dated written informed consent form. The FDA
(1998) regulations allow subjects to receive either a signed or unsigned copy. To be in
compliance with ICH E6 guideline, the investigator should include a statement in the
consent form that the subject will receive a signed and dated copy of the consent form.
Persons obtaining consent must then ensure that this procedure is followed.
✔✔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
guideline, they must: - ✔✔• 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.
* ICH (2016) E6 Section 4.8.10(n) states that the informed consent should indicate that
"the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be
granted direct access to the subject's original medical records for verification of clinical
trial procedures and/or data, without violating the confidentiality of the subject, to the
extent permitted by the applicable laws and regulations and that, by signing a written
informed consent form, the subject or the subject's legally acceptable representative is
authorizing such access." The FDA regulations at 21 CFR 50.25(a)(5) (Protection of
Human Subjects 2016) state only that in seeking informed consent, the following
information shall be provided to each subject:. . . (5) A statement describing the extent,
if any, to which confidentiality of records identifying the subject will be maintained and
that notes the possibility that the Food and Drug Administration may inspect the
records. While it is true that data sent out of the U.S. loses certain federal protections,
this statement is not required. The possibility of hacking data is a risk that should be
, addressed in the study design and conduct. Non-disclosure forms are not required for
communications with primary care providers.
✔✔Which of the following is an acceptable criterion for determining that a study of an
approved drug does not require an IND? - ✔✔• The study is not intended to be reported
to FDA to support a new indication or support a labeling change.
* The number of subjects in a study is not a consideration for IND exemption. Any study
that significantly increases risk to subjects or invokes an exception from informed
consent for emergency research (21 CFR 50.24) does not meet one of the criterion for
an IND exemption. Investigations that are not intended to be reported to FDA do qualify
as meeting one of the six required conditions for an IND exemption.
✔✔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? - ✔✔• IND report
* The sponsor-investigator is required to keep the FDA updated through IND Safety
Reports, IND amendments, and annual IND reports. IND Safety Reports are filed
throughout the study, not just annually. There is no requirement for an annual
submission of an IND renewal application or marketing plan.
✔✔Who is responsible for making the initial risk determination for a device being used
in a study? - ✔✔• The sponsor-investigator.
* The sponsor-investigator is responsible for making the initial risk determination and
presenting it to the IRB. The FDA is available to help sponsor-investigators and IRBs in
making the risk determination. The drug manufacturer is not involved in the risk
determination for a sponsor-investigator study.
✔✔Identify which party is responsible for reporting directly to the FDA the investigator's
financial interests with the sponsor: - ✔✔• The sponsor
* The investigator provides the sponsor with a completed form for reporting financial
interests to the FDA. The sponsor is responsible for providing the FDA with this
information. This includes potential financial interests in the sponsor's company or
financial interests that might be influenced positively or negatively by the outcome of the
clinical investigation.
✔✔Which of the following is an investigator's commitment to the sponsor? - ✔✔• Submit
a new Form FDA 1572 to the sponsor as needed
* The investigator must submit a new Form FDA 1572 to the sponsor when an
investigator is participating in a new protocol that has been added to the IND or when a
new investigator is added to the study. The IRB, not the sponsor, provides ongoing
approval for study continuation at the site. The investigator submits the financial
