CITI TRAINING
ASSESSMENT
TESTS WITH
ACTUAL
RESOLUTIONS.
, 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? - correct
ans: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.
How long is an investigator required to keep consent documents, IRB
correspondence, and research records? - correct ans:For a minimum of three
years after completion of the study
According to federal regulations, which of the following best describes when
expedited review of a new, proposed study may be used by the IRB? - correct
ans:The study involves no more than minimal risk and meets one of the
allowable categories of expedited review specified in federal regulations
Amendments involving changes to IRB-approved protocols do NOT need prior
IRB approval if: - correct ans:The changes must be immediately implemented
for the health and well-being of the subject.
IRB continuing review of a greater than minimal risk approved protocol that
is currently enrolling subjects must: - correct ans:Occur at least annually.
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: - correct ans:A breach of confidentiality
In order to grant a waiver or alteration of the requirements of informed
consent, an IRB must find which of the following: - correct ans:The research
could not practicably be carried out without the waiver of consent.
ASSESSMENT
TESTS WITH
ACTUAL
RESOLUTIONS.
, 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? - correct
ans: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.
How long is an investigator required to keep consent documents, IRB
correspondence, and research records? - correct ans:For a minimum of three
years after completion of the study
According to federal regulations, which of the following best describes when
expedited review of a new, proposed study may be used by the IRB? - correct
ans:The study involves no more than minimal risk and meets one of the
allowable categories of expedited review specified in federal regulations
Amendments involving changes to IRB-approved protocols do NOT need prior
IRB approval if: - correct ans:The changes must be immediately implemented
for the health and well-being of the subject.
IRB continuing review of a greater than minimal risk approved protocol that
is currently enrolling subjects must: - correct ans:Occur at least annually.
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: - correct ans:A breach of confidentiality
In order to grant a waiver or alteration of the requirements of informed
consent, an IRB must find which of the following: - correct ans:The research
could not practicably be carried out without the waiver of consent.
