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 antagonistic medication involvement in an opportune way, with regards to the IRB's arrangements and systems, utilizing the structures or the component given by the IRB. Unfriendly medication encounter is the surprising symptom, damage, poisonous quality, affectability response, or startling rate or seriousness of reactions or any troublesome and unintended sign, side effect, or malady transiently connected with the utilization of medicinal treatment or technique, paying little respect to whether it is viewed as identified with the therapeutic treatment or method.