CITI TRAINING EXAM
The sponsor must submit an IND Safety Report to the FDA if an adverse event is
(1) serious; (2) unexpected; and: - ANSWERS-(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: - ANSWERS-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? - ANSWERS-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: - ANSWERS-Report the elevated WBC to the sponsor as an unexpected
adverse event
The overall goal of monitoring, audits, and inspection activities is to: - ANSWERS-
Ensure the protection of human research subjects and data integrity
According to ICH E6, an inspection is defined as: - ANSWERS-An official review of
documents, facilities, records, and any other resources related to a clinical trial.
OHRP is an oversight body primarily concerned with: - ANSWERS-Protection of
human research subjects
According to ICH E6, an "audit" is defined as: - ANSWERS-A systematic and
independent examination of trial-related activities and documents.
When the FDA conducts an inspection, the inspectors will: - ANSWERS-Review
regulatory records
At which study visits can the site expect the sponsor to review subjects' signed
informed consent forms? - ANSWERS-Periodic and termination site visits
Which of the following best describes when the majority of case report form (CRF)
data are verified against source record information? - ANSWERS-Periodic site
visits
The sponsor must submit an IND Safety Report to the FDA if an adverse event is
(1) serious; (2) unexpected; and: - ANSWERS-(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: - ANSWERS-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? - ANSWERS-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: - ANSWERS-Report the elevated WBC to the sponsor as an unexpected
adverse event
The overall goal of monitoring, audits, and inspection activities is to: - ANSWERS-
Ensure the protection of human research subjects and data integrity
According to ICH E6, an inspection is defined as: - ANSWERS-An official review of
documents, facilities, records, and any other resources related to a clinical trial.
OHRP is an oversight body primarily concerned with: - ANSWERS-Protection of
human research subjects
According to ICH E6, an "audit" is defined as: - ANSWERS-A systematic and
independent examination of trial-related activities and documents.
When the FDA conducts an inspection, the inspectors will: - ANSWERS-Review
regulatory records
At which study visits can the site expect the sponsor to review subjects' signed
informed consent forms? - ANSWERS-Periodic and termination site visits
Which of the following best describes when the majority of case report form (CRF)
data are verified against source record information? - ANSWERS-Periodic site
visits
