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CITI GOOD CLINICAL PRACTICE
COURSE (US FDA FOCUS) 2025
BRAND NEW ACTUAL EXAM WITH
ANSWERS.
1. During the course of administration of an investigational drug,
the following events occurred: On Day 7, subject 603 had an
unexpected stroke that requires hospitalization; On Day 15,
subject 415 complained of nausea, vomiting, and headache
relieved by aspirin; On Day 21, subject 20 has brief dizzy spells
upon trying to stand. Which of these subject's events meets the
FDA definition of "serious" and "unexpected" and would require
the sponsor to file an IND Safety Report with the FDA? -
correct answer -Subject 603 only
2. Subject 311 has had elevated white blood cell (WBC) counts
for the past two (2) study visits, with no clinical signs or
symptoms. "Increased WBC count" is not listed in the
Investigator's Brochure (IB) as an adverse event. The
investigator should: - correct answer -Report the elevated WBC
to the sponsor as an unexpected adverse event
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3. According to ICH E6, an "audit" is defined as: - correct answer -
A systematic and independent examination of trial-related
activities and documents.
4. OHRP is an oversight body primarily concerned with: - correct
answer -Protection of human research subjects
5. The overall goal of monitoring, audits, and inspection activities
is to: - correct answer -Ensure the protection of human
research subjects and data integrity.
6. According to ICH E6, an inspection is defined as: - correct
answer -An official review of documents, facilities, records, and
any other resources related to a clinical trial.
7. When the FDA conducts an inspection, the inspectors will: -
correct answer -Review regulatory records.
8. All unused investigational agents are expected to be returned
to the sponsor at the: - correct answer -Termination site visit
CITI GOOD CLINICAL PRACTICE
COURSE (US FDA FOCUS) 2025
BRAND NEW ACTUAL EXAM WITH
ANSWERS.
1. During the course of administration of an investigational drug,
the following events occurred: On Day 7, subject 603 had an
unexpected stroke that requires hospitalization; On Day 15,
subject 415 complained of nausea, vomiting, and headache
relieved by aspirin; On Day 21, subject 20 has brief dizzy spells
upon trying to stand. Which of these subject's events meets the
FDA definition of "serious" and "unexpected" and would require
the sponsor to file an IND Safety Report with the FDA? -
correct answer -Subject 603 only
2. Subject 311 has had elevated white blood cell (WBC) counts
for the past two (2) study visits, with no clinical signs or
symptoms. "Increased WBC count" is not listed in the
Investigator's Brochure (IB) as an adverse event. The
investigator should: - correct answer -Report the elevated WBC
to the sponsor as an unexpected adverse event
, Page | 2
3. According to ICH E6, an "audit" is defined as: - correct answer -
A systematic and independent examination of trial-related
activities and documents.
4. OHRP is an oversight body primarily concerned with: - correct
answer -Protection of human research subjects
5. The overall goal of monitoring, audits, and inspection activities
is to: - correct answer -Ensure the protection of human
research subjects and data integrity.
6. According to ICH E6, an inspection is defined as: - correct
answer -An official review of documents, facilities, records, and
any other resources related to a clinical trial.
7. When the FDA conducts an inspection, the inspectors will: -
correct answer -Review regulatory records.
8. All unused investigational agents are expected to be returned
to the sponsor at the: - correct answer -Termination site visit
