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.

Quesiton : 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: 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.

Most relevent text from all around web: 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. 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 drug experience in a timely manner in keeping with the IRB' s policies and procedures using the forms or ... A subject in a clinical research trial experiences a serious unanticipated adverse drug experience . ... 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 ... 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 polic...