LONDON DRUGS TRAINING FINAL
TEST 2026 QUESTIONS WITH
CORRECT ANSWERS GRADED A+
◍ Who operates the Indiana State Crime Labs?.
Answer: They are part of the Indiana State Police.
◍ Who originally worked in Indiana crime labs?.
Answer: State troopers.
◍ Who works in the crime labs now?.
Answer: Civilian scientists with 4-year degrees in physical sciences
(biology, chemistry, physics) or social sciences (psychology, sociology).
◍ Which lab is the largest and most updated?.
Answer: the Indianapolis Regional Laboratory.
◍ What types of workspaces are in the Indianapolis lab?.
Answer: Large drug chemistry rooms, analysis rooms, and multiple
specialized units.
◍ What issue does Fort Wayne face with DNA evidence?.
Answer: Only one DNA scientist; must transport DNA evidence weekly to
Indianapolis for faster processing.
◍ What is the modern DNA evidence turnaround?.
Answer: 4-6 weeks (used to be 15-24 months in the 80s-90s).
◍ Which units are common across Indianapolis, Fort Wayne, Evansville, and
Lowell labs?.
Answer: Biology/DNA, Firearms, Latent Prints, Footwear/Tire impressions,
Drug Analysis.
◍ 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:.
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.?.
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?.
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?.
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.
TEST 2026 QUESTIONS WITH
CORRECT ANSWERS GRADED A+
◍ Who operates the Indiana State Crime Labs?.
Answer: They are part of the Indiana State Police.
◍ Who originally worked in Indiana crime labs?.
Answer: State troopers.
◍ Who works in the crime labs now?.
Answer: Civilian scientists with 4-year degrees in physical sciences
(biology, chemistry, physics) or social sciences (psychology, sociology).
◍ Which lab is the largest and most updated?.
Answer: the Indianapolis Regional Laboratory.
◍ What types of workspaces are in the Indianapolis lab?.
Answer: Large drug chemistry rooms, analysis rooms, and multiple
specialized units.
◍ What issue does Fort Wayne face with DNA evidence?.
Answer: Only one DNA scientist; must transport DNA evidence weekly to
Indianapolis for faster processing.
◍ What is the modern DNA evidence turnaround?.
Answer: 4-6 weeks (used to be 15-24 months in the 80s-90s).
◍ Which units are common across Indianapolis, Fort Wayne, Evansville, and
Lowell labs?.
Answer: Biology/DNA, Firearms, Latent Prints, Footwear/Tire impressions,
Drug Analysis.
◍ 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:.
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.?.
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?.
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?.
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.
