Serious adverse event

Investigators in human clinical trials are obligated to report these events in clinical study reports. Research suggests that these events are often inadequately reported in publicly available reports. Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting systematic reviews and meta-analyses of therapeutic interventions often unknowingly overemphasise health benefit. To balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials. ==Related terms==

Serious adverse reactions are serious adverse events judged to be related to drug therapy. A SUSAR (suspected unexpected serious adverse reaction) should be reported to a drug regulatory authority under an investigational license by using the CIOMS form (or in some countries an equivalent form). "Unexpected" means that for an authorised (approved) medicinal product that the event is not described in the product's labeling, or in the case of an investigational (yet to be approved or disapproved) product that the event is not listed in the Investigator’s Brochure. That is, the AE is unexpected for the drug or device. An adverse effect is an adverse event which is believed to be caused by a health intervention. ==Footnotes==