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GCP Audits and Inspections of Clinical Trials of Drugs and Biologics

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When the FDA conducts an inspection, the inspectors will:
Review regulatory records.
 
Ensure the protection of human research subjects and data integrity.
 
According to ICH E6 GCP, an “Audit” is defined as:
A systematic and independent examination of trial-related activities and documents.
 
Protection of human research subjects.
 
According to ICH E6 GCP, an inspection is defined as:
An official review of documents, facilities, records, and any other resources related to a clinical trial.
 
Which of the following is an important component of drug accountability?
Drug shipping and disposition records
 
Who has ultimate responsibility for an investigational product?
Investigator
 
Investigational product dispensing or administration information for the sponsor is recorded on the:
Case report form
 
The packaging of investigational drugs should ideally:
Be designed to help with subject compliance
 
Where is information on storage requirements for the investigational product usually found?
In the study protocol
 
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
 
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.
 
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
 
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
 
According to ICH E6, an “audit” is defined as:
A systematic and independent examination of trial-related activities and documents.
 
When the FDA conducts an inspection, the inspectors will:
Review regulatory records.
 
OHRP is an oversight body primarily concerned with:
Protection of human research subjects
 
An official review of documents, facilities, records, and any other resources related to a clinical trial.
 
The FDA requires retention of investigational drug study records for:
At least two (2) years after the investigational drug’s approval by the FDA
 
All unused investigational agents are expected to be returned to the sponsor at the:
Termination site visit
 
When should the sponsor-monitor conduct the most detailed review of the study protocol with the site’s study staff?
Site initiation visit
 
Which of the following should take place during periodic site visits?
Identification of protocol violations
 
Which of the following best describes when the majority of case report form (CRF) data are verified against source record information?
Periodic site visits
 
Which of the following is required at a prestudy site visit?
Evaluation of the site’s capacity to conduct the study
 
Which monitoring visit would not include an inventory of investigational agents?
Prestudy site visit

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