SUSAR reporting: serious, unexpected, and suspected

SUSAR reporting is the expedited clinical-trial case that sponsors are afraid of missing. The word is an acronym, not a vibe. A SUSAR is a suspected unexpected serious adverse reaction: serious by criterion, unexpected against the reference safety information, and suspected because there is a reasonable possibility the investigational product caused it. Miss any one of the three and you may still have an adverse event worth keeping. You do not have a SUSAR.

The three tests

Seriousness uses the ICH criteria: death, life-threatening, hospitalization or prolongation, disability, congenital anomaly, or a medically important event. Those are explained on the AE and SAE page. A grade 3 lab value is not automatically serious. An overnight admission might be.

Unexpected means the event is not consistent with the investigator's brochure, or with the company core data sheet if that is the reference your protocol names. Specificity matters. "Gastrointestinal disorder" in the brochure does not list every hepatic failure. The case should name the document version the reviewer used. AE Connect does not hold that document. Expectedness in the workspace is a suggestion to go and check it.

Suspected means a reasonable possibility of a causal relationship, not proof. WHO-UMC categories are one way teams talk about that possibility: certain, probable, possible, unlikely, or unassessable. A possible relationship is enough, in ordinary sponsor practice, to treat the event as suspected for expedited reporting. Unlikely is not. The judgment belongs to a qualified reviewer, and it has to be written down.

Clocks, without pretending the regions are the same

Under 21 CFR 312.32, the sponsor notifies FDA and participating investigators of potential serious risks. Unexpected fatal or life-threatening suspected adverse reactions are reported as soon as possible and in no case later than 7 calendar days after the sponsor's initial receipt of the information. Other serious and unexpected suspected adverse reactions are reported as soon as possible and no later than 15 calendar days after the sponsor determines that the information qualifies for reporting. Follow-up is sent as the new information arrives, on the expedited schedule your procedure names.

EU SUSAR reporting to the relevant authorities and ethics committees uses the same 7-day and 15-day outline for fatal or life-threatening SUSARs and for other SUSARs. The portal, the unblinding rules, and who else must be told are not the US procedure. A sponsor with sites in both places needs both paths. This page will not invent a combined workflow.

Day 0 is where intake fails. If the first email arrived Friday and nobody opened it until Monday, the receipt date is not Monday. The intake form has to show when the sponsor, or the CRO acting for the sponsor, first had the report. A later data-entry date in a safety database does not reset the clock.

Investigators, blinding, and the letter that is not the case

Expedited reporting is not only a file to the authority. Investigators on the protocol are notified so they can watch their own subjects. The letter to investigators is a separate artifact from the case narrative. Someone has to keep a list of who was told.

Blinded studies add a decision the intake form cannot make. For an expedited report, sponsors often unblind that one case so the authority sees the actual treatment, while the trial analysis stays blinded. Whether you unblind, who may see the result, and how it is walled off from the study team are protocol and SOP questions. AE Connect does not unblind anything. It never sees the randomization schedule.

What has to be true in the case before anyone files

A SUSAR submission is only as good as the case underneath it. Before a 7-day or 15-day file goes out, a reviewer should be able to point to the verbatim event, the seriousness criterion, the brochure version used for expectedness, the causality call, the receipt date, and the product and dose. Missing those and still hitting "submit" is how sponsors send a report they have to correct on day 6.

The AE Connect workspace can put that structure on a narrative quickly: seriousness, a suggested MedDRA term, causality, expectedness, and a 7-day or 15-day timeline, each with a reason. You accept or override. AE Connect integrates the reviewed case with the safety database your pharmacovigilance plan names. That database remains the system of record. How the electronic file itself is shaped is the subject of E2B(R3) ICSR submissions.

SUSARs also feed the annual picture. They do not replace a DSUR or IND annual report. One expedited case is not the development safety update.