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CITI TRAINING - GOOD CLINICAL PRACTICE
2025| BRAND NEW ACTUAL EXAM WITH 100%
VERIFIED QUESTIONS AND CORRECT
SOLUTIONS| GUARANTEED VALUE PACK| ACE
YOUR GRADES.
1. A double-blinded trial for a new indication is conducted under
an IND comparing two (2) marketed drugs, at twice the
approved prescribed doses. On Day 2, subject 603 had
difficulty breathing. Although it was life-threatening initially,
subject 603 was treated and discharged directly from the
emergency department after complete recovery. On Day 5,
subject 20 had a headache, which led to hospitalization and
required blood pressure lowering medications. These episodes
cannot be explained on the basis of the pharmacological
property of either drug or the subjects' medical histories. The
investigator would submit an SAE report for: - correct answer -
Both of the subjects
2. 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
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the sponsor to file an IND Safety Report with the FDA? -
correct answer - Subject 603 only
3. 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
4. Audits and Inspections of Clinical Trials - correct answer -
5. When the FDA conducts an inspection, the inspectors will: -
correct answer - Review regulatory records.
6. According to ICH E6, an "audit" is defined as: - correct answer -
A systematic and independent examination of trial-related
activities and documents.
7. OHRP is an oversight body primarily concerned with: - correct
answer - Protection of human research subjects
CITI TRAINING - GOOD CLINICAL PRACTICE
2025| BRAND NEW ACTUAL EXAM WITH 100%
VERIFIED QUESTIONS AND CORRECT
SOLUTIONS| GUARANTEED VALUE PACK| ACE
YOUR GRADES.
1. A double-blinded trial for a new indication is conducted under
an IND comparing two (2) marketed drugs, at twice the
approved prescribed doses. On Day 2, subject 603 had
difficulty breathing. Although it was life-threatening initially,
subject 603 was treated and discharged directly from the
emergency department after complete recovery. On Day 5,
subject 20 had a headache, which led to hospitalization and
required blood pressure lowering medications. These episodes
cannot be explained on the basis of the pharmacological
property of either drug or the subjects' medical histories. The
investigator would submit an SAE report for: - correct answer -
Both of the subjects
2. 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
, Page | 2
the sponsor to file an IND Safety Report with the FDA? -
correct answer - Subject 603 only
3. 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
4. Audits and Inspections of Clinical Trials - correct answer -
5. When the FDA conducts an inspection, the inspectors will: -
correct answer - Review regulatory records.
6. According to ICH E6, an "audit" is defined as: - correct answer -
A systematic and independent examination of trial-related
activities and documents.
7. OHRP is an oversight body primarily concerned with: - correct
answer - Protection of human research subjects
