Exam (elaborations)
GCP QUIZ QUESTIONS AND ANSWERS
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GCP QUIZ QUESTIONS AND ANSWERS...
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Which three factors contributed to the establishment of ICH?Lack of qualified patients to hire, site locations, and treatment accessibility
b. Incomplete medical records, insufficient supplies, and malfunctioning
equipment
c. Inadequate laboratory data, clinical trial sites that are unsuitable, and research
that isn't relevant to the patient population's geographic location.
d. Delays in the release of new medications, variations in national regulations,
and growing drug development expenses. - ANSWER delays in the release of
new medications, variations in national regulations, and growing drug
development expenses.
What are the Guidelines of the International Council for Harmonization (ICH)?
a. Documented guidelines for researchers on how to preserve information on
unapproved experimental drugs.
b. The Office for Human Research Protection's rules for participants signing up
for Phase I research.
c. Standardized guidelines to let the regulatory bodies in the US, Japan, and the
EU accept clinical data against one another.
d. Global guidelines for the production, distribution, and storage of
pharmaceuticals. - ANSWER standardized guidelines to help the US, EU, and
Japanese regulatory bodies accept clinical data more easily against one another.
Which of the following describes an ICH GCP principle?
, a. If there are any known dangers or difficulties for trial participants, clinical
studies shouldn't be carried out.
a. The sponsor should always designate a qualified monitor to oversee the
medical treatment provided to subjects.
c. Data from clinical trials should be captured, processed, and kept in a manner
that enables precise reporting, interpretation, and validation.
d. Clinical trial participants should be qualified based on their compliance with
ICH GCP. - ANSWER Accurate reporting, interpretation, and verification are
made possible by the proper handling, recording, and storage of clinical trial
data.
Which position among the following is ultimately in charge of the caliber and
accuracy of the data generated during a clinical trial?
a. IEC/IRB
b. The investigator
c. The Sponsor
d. ANSWER Sponsor, a contract research organization
Which of the following positions is ultimately in charge of how a trial is
conducted at a clinical site?
a. IEC/IRB
b. The investigator
c. The Sponsor
d. ANSWER Investigator, a contract research organization
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