CITI Training - Good Clinical Exam QUESTIONS AND
CORRECT ANSWERS| ACCURATE REAL EXAM WITH
FREQUENTLY TESTED QUESTIONS|ALREADY A
GRADED|GUARANTEED PASS|LATEST UPDATE 2025
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:
......answer. ... 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? ......answer. ... 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: ......answer .... Report the elevated WBC to the sponsor as
an unexpected adverse event
Audits and Inspections of Clinical Trials ......answer.....
When the FDA conducts an inspection, the inspectors will:
......answer. ... Review regulatory records.
According to ICH E6, an "audit" is defined as: ......answer. .... A systematic and
independent examination of trial-related activities and documents.
OHRP is an oversight body primarily concerned with:
......answer. ... Protection of human research subjects
The overall goal of monitoring, audits, and inspection activities is to:
......answer. ... Ensure the protection of human research subjects and data
integrity.
, According to ICH E6, an inspection is defined a ......answer..... An official
review of documents, facilities, records, and any other resources related to a
clinical trial.
Monitoring of Clinical Trials by Industry Sponsors ......answer.....
Which monitoring visit would not include an inventory of investigational
agents? ......answer. ... Prestudy site visit
When should the sponsor-monitor conduct the most detailed review of the
study protocol with the site's study staff? ......answer. ... Site initiation visit
Which of the following is required at a prestudy site visit?
......answer. ... Evaluation of the site's capacity to conduct the study
All unused investigational agents are expected to be returned to the sponsor
at the: ......answer .... Termination site visit
Which of the following best describes when the majority of case report form
(CRF) data are verified against source record information?
......answer. ... Periodic site visits
CORRECT ANSWERS| ACCURATE REAL EXAM WITH
FREQUENTLY TESTED QUESTIONS|ALREADY A
GRADED|GUARANTEED PASS|LATEST UPDATE 2025
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:
......answer. ... 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? ......answer. ... 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: ......answer .... Report the elevated WBC to the sponsor as
an unexpected adverse event
Audits and Inspections of Clinical Trials ......answer.....
When the FDA conducts an inspection, the inspectors will:
......answer. ... Review regulatory records.
According to ICH E6, an "audit" is defined as: ......answer. .... A systematic and
independent examination of trial-related activities and documents.
OHRP is an oversight body primarily concerned with:
......answer. ... Protection of human research subjects
The overall goal of monitoring, audits, and inspection activities is to:
......answer. ... Ensure the protection of human research subjects and data
integrity.
, According to ICH E6, an inspection is defined a ......answer..... An official
review of documents, facilities, records, and any other resources related to a
clinical trial.
Monitoring of Clinical Trials by Industry Sponsors ......answer.....
Which monitoring visit would not include an inventory of investigational
agents? ......answer. ... Prestudy site visit
When should the sponsor-monitor conduct the most detailed review of the
study protocol with the site's study staff? ......answer. ... Site initiation visit
Which of the following is required at a prestudy site visit?
......answer. ... Evaluation of the site's capacity to conduct the study
All unused investigational agents are expected to be returned to the sponsor
at the: ......answer .... Termination site visit
Which of the following best describes when the majority of case report form
(CRF) data are verified against source record information?
......answer. ... Periodic site visits
