Question

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?


A. Do not report the adverse drug experience to the IRB since it is a common adverse experience.

B. Report the adverse drug experience to the IRB only if there are several other occurrences.

C. Report the adverse drug experience as part of the continuing review report.

D. 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

Answer 1

Answer:

d

Explanation:

it needs to be reported as soon as possible and protocols must be followed to be sure it is an adverse reaction

Answer 2

With respect to the IRB, after the discovery of the adverse event occurrence, the investigator should proceed by D. 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.

The Institutional Review Board (IRB) is a adminstrative body that is put on place to protect the welfare and rights of the human beings who take part in a research.

Based in the information given, the adverse drug experience should be reported in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.

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