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Good Clinical Practice (GCP)
(3) there is a reasonable possibility that the drug caused the event. - ✔✔The sponsor
must submit an IND safety report to the FDA if an adverse event is (1) serious; (2)
unexpected; AND:
9 years or more - ✔✔Development of most new drugs from discovery to marketing
approval usually takes:
A systematic and independent examination of trial-related activities and documents. -
✔✔According to ICH E6 GCP, an "Audit" is defined as:
An investigator's agreement - ✔✔An investigator conducting a study of a medical
device under an IDE is required to complete and sign which of the following?
An official review of documents, facilities, records, and any other resources related to a
clinical trial. - ✔✔According to ICH E6 GCP, an inspection is defined as:
be designed to help with subject compliance - ✔✔The packaging of investigational
drugs should ideally
Both of the subjects. - ✔✔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:
Case report form - ✔✔Investigational product dispensing or administration information
for the sponsor is recorded on the:
, 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 - ✔✔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 guidelines, they must:
Determining that the study has maximized benefits and minimized risks. - ✔✔Which of
the following is an example of how the Principle of Beneficence can be applied to a
study employing human subjects?
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 - ✔✔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?
Drug shipping and disposition records - ✔✔Which of the following is an important
component of drug accountability?
During the conduct of the study and at termination - ✔✔When must the investigator
update the IRB about the progress of a trial?
Ensure the protection of human research subjects and data integrity. - ✔✔The overall
goal of monitoring, audits, and inspection activities is to:
Ensuring subject safety. - ✔✔Accurate reporting of adverse events is most important
for:
Evaluation of the site's capacity to conduct the study - ✔✔Which of the following is
required at a prestudy site visit?
FDA. - ✔✔Form FDA 1572, Statement of Investigator, is legally binding between the
Investigator and the:
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