CITI - SoCRA - GCP For Clinical Trials With Investigational Drugs And Biologics (ICH Focus)

Which of the following lists the three principles included in the Belmont Report?

Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?

Which of the following best describes the principle of informed consent as described in the Belmont Report?

When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA?

Which of the following is a criterion for determining if a study of an approved drug is exempt from the require of an IND?

Which of the following reports must be filed using an Form FDA 1572?

Identify which party is responsible for reporting directly to the FDA the investigator's financial interests with the sponsor:

In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to:

Form FDA 1572, Statement of Investigator, is legally binding between the Investigator and the:

The investigator must report adverse events to the:

When must the investigator update the IRB about the progress of a trial?

Which of the following is an investigator's commitment to the sponsor?

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?

A 46-year-old man is currently enrolled in a phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?

Which of the following statements in a consent form is an example of language that appears to waive a subject's rights?

An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator:

Under which circumstance does the FDA allow verbal consent prior to participation in a research study?

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

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?

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

The FDA requires retention of investigational drug study records for:

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

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

If the FDA Investigator issues a FDA Form 483 after an inspection, the clinical investigator should:

When the FDA conducts an inspection, the inspectors will:

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

According to ICH E6 GCP, an "Audit" is defined as:

According to ICH E6 GCP, an inspection is defined as:

Development of most new drugs from discovery to marketing approval usually takes:

The first randomized, controlled study of an experimental drug versus aspirin for postoperative pain control will enroll 55 subjects in each arm. Which of the following best describes the clinical phase of this study?

Adults with more than a 12-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was 1200 subjects. Which of the following best describes the clinical phase of this study?

Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?

Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?

For a phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure?

A primary purpose of the ICH is to:

The ICH GCP Guidelines:

The ICH E6 GCP describes standards that apply to:

In the United States, following the ICH E6 GCP is:

The FDA will apply:

What is the legal status of ICH in U.S.?

In terms of explaining the probability of assignment to trial arms in consent forms, which is true?

ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must:

The new ICH E6 integrated addendum (R2) requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following?

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 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 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 occur: On Day 7, subject 603 has an unexpected stroke that requires hospitalization. On Day 15, subject 415 complains of nausea, vomiting, and headache relieved by aspirin. On Day 21, subject 20 has brief dizzy spells upon trying to stand. An IND Safety Report is most likely filed by the sponsor with the FDA for the observations associated with:

Subject 311 has had elevated white blood cell (WBC) counts for the past 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: