CITI training

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

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections:

Pregnant women, prisoners, children

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.

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.

Which is an example of a situation where deferential vulnerability might be a factor?

A physician recruiting patients to be subjects

An example of an individual financial COI is:

A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.

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

Recruiting into research ...

Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.

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

Conduct or supervise the investigation personally

Which of the following brought increased public attention to the problems with the IRB system?

Death of Research Subject (Jesse Gelsinger)

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.

HIPAA includes in its definition of "research," activities related to:

Development of generalizable knowledge.

During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:

Disclose their potential COI and may answer questions, but recuse themselves from voting

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

Drug shipping and disposition records

When conducting research that involves collecting biological specimens for genetic testing, which of the following issues is the most important for the IRB to consider?

Effects of findings on other family members

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.

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

Evaluation of the site's capacity to conduct the study

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

FDA

How long is an investigator required to keep consent documents, IRB correspondence, and research records?

For a minimum of three years after completion of the study

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

It is a FDA guidance

A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:

It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success

A primary purpose of the ICH is to:

Minimize the need for redundant research.

IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:

Occur at least annually.

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

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.

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

Sponsor

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

Submit a new Form FDA 1572 to the sponsor as needed

Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:

The changes must be immediately implemented for the health and well-being of the subject.

In order to grant a waiver or alteration of the requirements of informed consent, an IRB must find which of the following:

The research could not practicably be carried out without the waiver of consent.

A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects?

The researcher will not be interacting/intervening with subjects and the data has no identifiers.

The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:

There may be bias by the peer reviewer as to the area of research

Issued in 1974, 45 CFR 46 raised to regulatory status:

US Public Health Service Policy

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

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

9 years or more

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

During the conduct of the study and at termination

Informed consent is considered an application of which Belmont principle?

Respect for Persons

Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from:

Health insurance and employment discrimination

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.

The use of prisoners in research is a concern under the Belmont principle of Justice because:

Prisoners may not be used to conduct research that only benefits the larger society

As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research participants in NIH -funded genetic research for broad research use of data and data sharing, even if the cell lines or specimens are:

De-Identified

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

HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:

Identifiable health information that is created or held by covered entities and their business associates.

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.

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

Information, comprehension, voluntariness.

Which of the following was the result of the Beecher article?

Realization that ethical abuses are not limited to the Nazi regime

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.

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

The sponsor

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

Case report form

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

ICH E6 describes standards that apply to:

Investigators, sponsors, and IRBs

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

Termination site visit

Investigator A conducts research on emphysema using biospecimens from human subjects. The consent form indicates that the research will focus exclusively on emphysema. Investigator B wishes to use the biospecimens for research on lung cancer. Can Investigator B use the specimens for cancer research without re-consent if the specimens are de-identified?

Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.

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

The study is minimal risk.

The packaging of investigational drugs should ideally:

Be designed to help with subject compliance

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

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

Site initiation visit

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.

Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens?

Original signed consent documents include provisions for recontacting subjects

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

Periodic and termination site visits

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

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.

The FDA requires retention of investigational drug study records for:

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

An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:

A breach of confidentiality

A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:

A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:

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

Who has ultimate responsibility for an investigational product?

Investigator

When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:

Is there a power differential between researchers and subjects?

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?

Physical control, coercion, undue influence, and manipulation

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 COI management plan aims to:

Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?

Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.

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

The ICH GCP guidelines:

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

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:

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.

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

The sponsor-investigator.

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?

The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

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

When required, the information provided to the data subject in a HIPAA disclosure accounting ...

must be more detailed for disclosures that involve fewer than 50 subject records.

In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:

Situational cognitive vulnerability