CITI questions Flashcards
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
Development of most new drugs, from discovery to marketing approval, usually takes:
9 years or more
Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?
Preclinical
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
Phase I studies often assess a drug’s pharmacokinetic and pharmacodynamic profiles in normal healthy volunteers unless toxicity precludes such exposure.
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 of the following are the three principles included in the Belmont Report?
Respect for Persons, Beneficence, Justice.
In terms of explaining the probability of assignment to trial arms in consent forms, what is true of the ICH and FDA?
ICH notes that it should be included, but does not specify how the information should be presented. The FDA has no such requirement about including probability for random assignment to each treatment, but does require an identification of any procedures which are experimental.
The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage quality throughout all stages of the trial process. Should these systems identify study risks to determine which may safely be omitted from continual monitoring.
Yes, Risk reduction activities may be incorporated in protocol design and implementation, monitoring plans, and agreements.
Regarding subject receipt of a signed and dated copy of the consent forms, what do FDA regulations allow?
The FDA regulations allow subjects or the legally acceptable representatives (LARs) to receive either a signed or unsigned copy.
ICH, however, requires that the subject or the legally acceptable representative (LAR) receive a copy of the signed and dated written informed consent 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 disclose to the subjects that WHO might have access to the subject’s medical records?
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
The FDA regulations at 21 CFR 50 state only that in seeking informed consent, the following information shall be provided to each subject: A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.
What is the status of ICH in U.S.?
It is a FDA guidance. It is not a law in the US. Therefore, compliance is voluntary, but as with any published FDA guidance, compliance is considered part of good clinical practice.
When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of what to the FDA?
IND report
Who is responsible for making the initial risk determination for a device being used in a study?
sponsor-investigator
The sponsor-investigator is responsible for making the initial risk determination and presenting it to the IRB. The FDA is available to help sponsor-investigators and IRBs in making the risk determination. The drug manufacturer is not involved in the risk determination for a sponsor-investigator study.
Form FDA 1572, Statement of Investigator, is legally binding between the investigator and the:
FDA
When must the investigator update the IRB about the progress of a trial?
During the conduct of the study and at termination
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
Where is information on storage requirements for the investigational product usually found?
In the study protocol
An investigator conducting a study of a medical device under an IDE is required to complete and sign what?
An investigator’s agreement
Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the FDA by the:
Sponsor
The investigator reports UADEs to the sponsor and the local IRB. The sponsor transmits evaluations of these reports to the FDA.
Who is ultimately responsible for product accountability at the study site?
Investigator
Sponsors must notify regulatory authorities and all participating investigators in writing of events that are both unexpected and serious, and associated with the use of the investigational drug no later than:
15 calendar days
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.
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. Subject 603 had life-threatening symptoms and 20 was hospitalized
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?
The incident for subject 603 meets the FDA definition of “serious” and “unexpected.” The incidents for subjects 20 and 415 do not meet the FDA definition of “serious.”
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 investigator should notify the sponsor according to the sponsor’s requirements. The laboratory tests already were repeated at the second study visit and remained abnormal. MedWatch reports may be used to notify the sponsor of the event, but the investigator would not file the report with the FDA. The sponsor would notify FDA.
An inspection is conducted by?
A regulatory agency (such as the FDA) conducts an inspection. The sponsor, CRO, and monitor perform monitoring and audits.
The overall goal of monitoring, audits, and inspection activities is to:
Ensure the protection of human research subjects and data integrity.
When the FDA conducts an inspection, the inspectors will:
Review regulatory records.
According to ICH E6, an “audit” is defined as:
A systematic and independent examination of trial-related activities and documents.
OHRP is an oversight body primarily concerned with:
Protection of human research subjects
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.
