Good Clinical Practice (GCP)

According to ICH E6, an inspection is defined as:

An official review of documents, facilities, records, and any other resources related to a clinical trial.

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?

IND report

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

Evaluation of the site's capacity to conduct the study

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

It is a FDA guidance.

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.

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

9 years or more

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

A systematic and independent examination of trial-related activities and documents.

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

The FDA requires retention of investigational drug study records for:

At least two (2) years after the investigational drug's approval by the FDA

The packaging of investigational drugs should ideally:

Be designed to help with subject compliance

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

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

Case report form

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:

Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records

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

Conduct or supervise the investigation personally

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

Determining that the study has maximized benefits and minimized risks.

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?

Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.

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

Ensure the protection of human research subjects and data integrity.

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

Drug shipping and disposition records

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

During the conduct of the study and at termination

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

FDA

ICH E6 describes standards that apply to:

Investigators, sponsors, and IRBs

Which of the following statements in a consent form is an example of exculpatory language?

I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

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

ICH notes that it should be included, but does not specify how the information should be presented.

The new ICH E6(R2) integrated addendum 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?

Identification of study risks to determine which may safely be omitted from continual monitoring.

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

In the study protocol

Which of the following best describes the principle of Respect for Persons as described in the Belmont Report?

Information, comprehension, voluntariness

Who is ultimately responsible for product accountability at the study site?

Investigator

A primary purpose of the ICH is to:

Minimize the need for redundant research.

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

Phase I

Adults with more than a twelve (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 twelve-hundred (1200) subjects. Which of the following best describes the clinical phase of this study?

Phase III

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

Preclinical

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

Preclinical data

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

Prestudy site visit

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

OHRP is an oversight body primarily concerned with:

Protection of human research subjects

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.

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

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

Respect for Persons, Beneficence, Justice

When the FDA conducts an inspection, the inspectors will:

Review regulatory records.

The ICH GCP guidelines:

Set standards for the design, conduct, monitoring and reporting of clinical research.

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

Site initiation visit

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

Sponsor

The Investigator must report adverse events to the:

Sponsor

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

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

Submit a new Form FDA 1572 to sponsor as needed

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

Termination site visit

Regarding subject receipt of a signed and dated copy of the consent forms, which is true about FDA regulations?

The FDA regulations allow subjects or the legally acceptable representatives (LARs) to receive either a signed or unsigned copy.

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 for the individual's legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator:

The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.

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

The sponsor

Who is responsible for making the initial risk determination for a device being used in a study?

The sponsor-investigator.

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

The study is minimal risk.

Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND?

The study is not intended to be reported to FDA to support a new indication or support a labeling change.

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

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

Voluntary for FDA-regulated drug studies.

A 510(k) Premarket Notification is submitted:

When the new device to be marketed is substantially similar (equivalent) to one already on the market

Accurate reporting of adverse events is most important for:

Ensuring subject safety.