CITI Training

In the United States, following the ICH E6 guideline is

Voluntary for FDA-regulated drug studies.

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

FDA.

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

Site initiation 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

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

9 years or more

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

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

Drug shipping and disposition records

What are the three principles discussed in the Belmont Report?

Justice, Beneficence, and Respect for Persons

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.

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

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

During the conduct of the study and at termination

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.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.

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

In the study protocol

Who has ultimate responsibility for an investigational product?

Investigator

The ICH E6 GCP describes standards that apply to

Investigators, sponsors, and IRBs.

A 510(k) Premarket Notification is submitted:

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

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 packaging of investigational drugs should ideally

Be designed to help with subject compliance

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

Identification of protocol violations

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

The sponsor

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

The study is minimal risk.

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.

Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? A. Providing detailed information about the study and obtaining the subject's consent to participate. B. Insuring that the selection of subjects includes people from all segments of the population. C. Determining that the study has maximized benefits and minimized risks. D. Ensuring that confidentiality is maintained.

C. Determining that the study has a maximization of benefits and a minimization of risks.

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

Case report form

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?

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

Which of the following best describes the principle of informed consent as described in the Belmont Report? A. Voluntariness, risk/benefit assessment, selection of subjects. B. Comprehension, conflicts of interest, risk/benefit ratio. C. Risk/benefit assessment, justification of research, comprehension. D. Information, comprehension, voluntariness.

D. Information, Comprehension, voluntariness.

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

Ensure the protection of human research subjects and data integrity

Accurate reporting of adverse events is most important for:

Ensuring subject safety.

What is the legal 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

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

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

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

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

Conduct or supervise the investigation personally.

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?

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

A primary purpose of the ICH is to

Minimize the need for redundant research.

At which study visits can the site expect the sponsor to review subjects' signed informed consent forms?

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?

Periodic site visits

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 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?

Phase III

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

Preclinical

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

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

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.

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

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: Sign the consent form on behalf of the subject and use the test article. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so the test article can be used immediately. Do not use the test article until either the subject or the subject's legally authorized representative can give consent. 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.

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.

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