[Solved]: A subject in a cllnical research trilal experiences…

A subject in a cllnical research trilal experiences a serious, unandidpated 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 to the IRS only If there are several ctitur occurrences. Report the adverse drug experience as part of the continuing review report 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 IRS. Do not report the adverse drug experience to the IRB since it ts a common adverse experience.