GCP

Which of the following is an important component of drug accountability?

Who has ultimate responsibility for an investigational product?

Investigational product dispensing or administration information for the sponsor is recorded on the:

The packaging of investigational drugs should ideally:

Where is information on storage requirements for the investigational product usually found?

An investigator conducting a study of a medical device under an IDE is required to complete and sign which of the following?

A 510(k) Premarket Notification is submitted:

Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the FDA by the:

When evaluating the causality of an adverse event, which of the following should be a consideration?

Accurate reporting of adverse events is most important for:

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?

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?

The sponsor must submit an IND Safety Report to the FDA if an adverse event is (1) serious; (2) unexpected; and:

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:

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 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:

According to ICH E6, an "audit" is defined as:

When the FDA conducts an inspection, the inspectors will:

The overall goal of monitoring, audits, and inspection activities is to:

OHRP is an oversight body primarily concerned with:

According to ICH E6, an inspection is defined as:

The FDA requires retention of investigational drug study records for:

All unused investigational agents are expected to be returned to the sponsor at the:

When should the sponsor-monitor conduct the most detailed review of the study protocol with the site's study staff?

Which of the following should take place during periodic site visits?

Which of the following best describes when the majority of case report form (CRF) data are verified against source record information?

Which of the following is required at a prestudy site visit?

Which monitoring visit would not include an inventory of investigational agents?