CITI TRAINING -GOOD CLINICAL PRACTICE
EXAM 2025/2026 WITH ACTUAL CORRECT
QUESTIONS AND VERIFIED DETAILED
ANSWERS |FREQUENTLY TESTED
QUESTIONS AND SOLUTIONS |ALREADY
GRADED A+|NEWEST|BRAND NEW
VERSION!!|GUARANTEED PASS
An investigator conducting a study of a medical device under an IDE is required to complete and
sign which of the following?
An investigator's agreement
A 510(k) Premarket Notification is submitted:
When the new device to be marketed is substantially similar (equivalent) to one already on the
market
Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the FDA by the:
Sponsor
Detecting and Evaluating Adverse Events
When evaluating the causality of an adverse event, which of the following should be a
consideration?
The timing of the event in relation to administration of the investigational agent
Accurate reporting of adverse events is most important for:
Ensuring subject safety.
A subject of a research study is a passenger in a car involved in a motor vehicle crash. The
subject sustained a broken wrist and mild concussion. The subject was treated and released
from the emergency department. What should the investigator do when learning of the crash?
Report adverse events of both a broken wrist and a mild concussion.
1|Page
, A subject presents to the emergency department (ED) with complaints of chest pain and
shortness of breath. Blood studies are positive for a heart attack and the subject is hospitalized.
The subject has a history of coronary artery disease. The subject reports to the ED nurse that he
is currently enrolled in a Phase I study of a new lipid lowering agent. Which individual should
determine causality of the serious adverse event?
Principal Investigator
Reporting Serious Adverse Events
The sponsor must submit an IND Safety Report to the FDA if an adverse event is (1) serious; (2)
unexpected; and:
(3) there is a reasonable possibility that the drug caused the event.
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:
Both of the subjects
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?
Subject 603 only
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:
Report the elevated WBC to the sponsor as an unexpected adverse event
Audits and Inspections of Clinical Trials
When the FDA conducts an inspection, the inspectors will:
Review regulatory records.
2|Page
EXAM 2025/2026 WITH ACTUAL CORRECT
QUESTIONS AND VERIFIED DETAILED
ANSWERS |FREQUENTLY TESTED
QUESTIONS AND SOLUTIONS |ALREADY
GRADED A+|NEWEST|BRAND NEW
VERSION!!|GUARANTEED PASS
An investigator conducting a study of a medical device under an IDE is required to complete and
sign which of the following?
An investigator's agreement
A 510(k) Premarket Notification is submitted:
When the new device to be marketed is substantially similar (equivalent) to one already on the
market
Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the FDA by the:
Sponsor
Detecting and Evaluating Adverse Events
When evaluating the causality of an adverse event, which of the following should be a
consideration?
The timing of the event in relation to administration of the investigational agent
Accurate reporting of adverse events is most important for:
Ensuring subject safety.
A subject of a research study is a passenger in a car involved in a motor vehicle crash. The
subject sustained a broken wrist and mild concussion. The subject was treated and released
from the emergency department. What should the investigator do when learning of the crash?
Report adverse events of both a broken wrist and a mild concussion.
1|Page
, A subject presents to the emergency department (ED) with complaints of chest pain and
shortness of breath. Blood studies are positive for a heart attack and the subject is hospitalized.
The subject has a history of coronary artery disease. The subject reports to the ED nurse that he
is currently enrolled in a Phase I study of a new lipid lowering agent. Which individual should
determine causality of the serious adverse event?
Principal Investigator
Reporting Serious Adverse Events
The sponsor must submit an IND Safety Report to the FDA if an adverse event is (1) serious; (2)
unexpected; and:
(3) there is a reasonable possibility that the drug caused the event.
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:
Both of the subjects
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?
Subject 603 only
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:
Report the elevated WBC to the sponsor as an unexpected adverse event
Audits and Inspections of Clinical Trials
When the FDA conducts an inspection, the inspectors will:
Review regulatory records.
2|Page
