[Answer] 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?

Answer: 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.

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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 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 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 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 . 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 . 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 ? Report the adverse dr...

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