Citi Training Test Questions and Answers 100% Solved
According to federal regulations, the expedited review process may be used when the study
procedures pose: Correct Ans-No more than minimal risk and the research activities fall
within regulatory categories identified as eligible.
According to the federal regulations, research is eligible for exemption, if Correct Ans-The
research falls into one of six categories of research activity described in the regulations.
Which of the following statements about the relationship between an institution and the
institution's IRB(s) is correct? Correct Ans-officials of the institution may overrule an IRB
approval.
Continuing review of an approved and ongoing protocol Correct Ans-Must occur within 12
months of the approval date.
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, the expedited review process may be used when the study
procedures pose: Correct Ans-No more than minimal risk and the research activities fall
within regulatory categories identified as eligible.
According to the federal regulations, research is eligible for exemption, if Correct Ans-The
research falls into one of six categories of research activity described in the regulations.
Which of the following statements about the relationship between an institution and the
institution's IRB(s) is correct? Correct Ans-officials of the institution may overrule an IRB
approval.
Continuing review of an approved and ongoing protocol Correct Ans-Must occur within 12
months of the approval date.
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
