CITI GCP Training Questions With All Correct Answers
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: correct answer -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.
What is the status of ICH in U.S.? correct answer -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? correct answer -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.
The new ICH E6(R2) integrated addendum 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?
correct answer -Identification of study risks to determine which may safely
be omitted from continual monitoring.
ICH (2016) E6 Section 5.0.4 states that the sponsor should decide which risks
to reduce and/or which risks to accept. The approach used to reduce risk to
an acceptable level should be proportionate to the significance of the risk. Risk
reduction activities may be incorporated in protocol design and
implementation, monitoring plans, and agreements.
Routine scheduled audits of study documentation whether on-site or remote
are not considered fully responsive to the need for continuous monitoring of
data under a proactive risk-based approach.
While data from Case Report Forms may be selected for ongoing monitoring,
there is no ICH template and a "one-size-fits-all" approach is not appropriate
for study-specific monitoring.
, The use of any specific method of analysis quality improvement is not
required and routine annual review may not be sufficient for monitoring the
study-specific risks that have been identified.
In terms of explaining the probability of assignment to trial arms in consent
forms, which is true? correct answer -ICH notes that it should be included,
but does not specify how the information should be presented.
ICH (2016) E6 Section 4.8.10(c) states that "Both the informed consent
discussion and the written informed consent form and any other written
information to be provided to subjects should include the probability for
random assignment to each treatment;" however, it does not specify how the
information should be presented. The FDA has no such requirement about
including probability for random assignment to each treatment, but does
require an identification of any procedures which are experimental.
This difference can be addressed by including a description of each arm of the
study in the consent form, and including a statement about the likelihood of
receiving each of the study arms.
Form FDA 1571 correct answer -Investigational New Drug Application. By
signing the 1571, the sponsor-investigator agrees to the following:
Not to begin clinical investigations until thirty (30) days after FDA's receipt of
the IND, unless the investigator receives earlier notification from the FDA
Not to begin or continue investigations covered by the IND if those studies are
placed on clinical hold
That an IRB/IEC that complies with 21 CFR 56 will be responsible for initial
and continuing review and approval of each of the studies in the proposed
clinical investigations
To conduct the investigation in accordance with all other applicable
regulatory requirements
Form FDA 1572 correct answer -Statement of Investigator
Investigator's Brochure correct answer -A compilation of the clinical and
nonclinical data on the investigational products which is relevant to the study
of the investigational products in human subjects. (ICH GCP E6 1.36)
Letters of Cross-Reference correct answer -In some instances, the
manufacturer of an IND might already have an active IND for the drug being
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: correct answer -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.
What is the status of ICH in U.S.? correct answer -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? correct answer -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.
The new ICH E6(R2) integrated addendum 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?
correct answer -Identification of study risks to determine which may safely
be omitted from continual monitoring.
ICH (2016) E6 Section 5.0.4 states that the sponsor should decide which risks
to reduce and/or which risks to accept. The approach used to reduce risk to
an acceptable level should be proportionate to the significance of the risk. Risk
reduction activities may be incorporated in protocol design and
implementation, monitoring plans, and agreements.
Routine scheduled audits of study documentation whether on-site or remote
are not considered fully responsive to the need for continuous monitoring of
data under a proactive risk-based approach.
While data from Case Report Forms may be selected for ongoing monitoring,
there is no ICH template and a "one-size-fits-all" approach is not appropriate
for study-specific monitoring.
, The use of any specific method of analysis quality improvement is not
required and routine annual review may not be sufficient for monitoring the
study-specific risks that have been identified.
In terms of explaining the probability of assignment to trial arms in consent
forms, which is true? correct answer -ICH notes that it should be included,
but does not specify how the information should be presented.
ICH (2016) E6 Section 4.8.10(c) states that "Both the informed consent
discussion and the written informed consent form and any other written
information to be provided to subjects should include the probability for
random assignment to each treatment;" however, it does not specify how the
information should be presented. The FDA has no such requirement about
including probability for random assignment to each treatment, but does
require an identification of any procedures which are experimental.
This difference can be addressed by including a description of each arm of the
study in the consent form, and including a statement about the likelihood of
receiving each of the study arms.
Form FDA 1571 correct answer -Investigational New Drug Application. By
signing the 1571, the sponsor-investigator agrees to the following:
Not to begin clinical investigations until thirty (30) days after FDA's receipt of
the IND, unless the investigator receives earlier notification from the FDA
Not to begin or continue investigations covered by the IND if those studies are
placed on clinical hold
That an IRB/IEC that complies with 21 CFR 56 will be responsible for initial
and continuing review and approval of each of the studies in the proposed
clinical investigations
To conduct the investigation in accordance with all other applicable
regulatory requirements
Form FDA 1572 correct answer -Statement of Investigator
Investigator's Brochure correct answer -A compilation of the clinical and
nonclinical data on the investigational products which is relevant to the study
of the investigational products in human subjects. (ICH GCP E6 1.36)
Letters of Cross-Reference correct answer -In some instances, the
manufacturer of an IND might already have an active IND for the drug being
