SUSAR Assessment Tool — 7/15-Day Expedited Timelines

Quick Answer

A SUSAR (suspected unexpected serious adverse reaction) is a serious adverse reaction with a reasonable suspected causal relationship to an investigational medicinal product that is unexpected against the applicable Reference Safety Information (RSI)—typically the investigator brochure section for IMPs or SmPC/label for comparators. Fatal or life-threatening SUSARs are commonly reported within 7 calendar days of sponsor awareness, with relevant follow-up within a further 8 days; other SUSARs within 15 calendar days. This interactive decision tree supports pharmacovigilance triage for seriousness, causality, expectedness, minimum ICH E2A case criteria, and likely expedited timeline—it does not replace sponsor SOPs, medical review, or E2B(R3) submission.

SUSAR triage logic (all required)

Serious (ICH E2A) + Suspected causality + Unexpected vs RSI + Minimum case criteria = SUSAR

Fatal or life-threatening SUSAR → likely 7 calendar days (+ 8-day follow-up). Other SUSAR → likely 15 calendar days. Confirm clocks against sponsor SOP and local regulation.

How to Use This Decision Tree

Confirm ICH E2A seriousness first—use the Seriousness Checker if the case narrative is unclear on death, life-threatening status, hospitalization, disability, congenital anomaly, or important medical event.

Assess suspected causality: is there a reasonable possibility the IMP caused or contributed to the serious event? Document WHO-UMC or company causality rationale separately.

Compare the reaction against the RSI version in effect at event onset—IB RSI section for IMP, SmPC or label for comparators. Unexpected by nature, severity, specificity, or outcome qualifies.

Verify minimum ICH E2A case criteria before day 0: identifiable patient, suspect product, reporter, serious unexpected event, and reasonable causality.

If SUSAR criteria are met, note fatal/life-threatening status for 7-day vs 15-day timeline, then confirm recipients, clock start, and E2B submission per sponsor SOP.

SUSAR Definition

A SUSAR is a suspected unexpected serious adverse reaction. In clinical trial safety reporting, the label is generally applied when the event is serious, there is a reasonable suspected causal relationship to the investigational medicinal product, and the reaction is not consistent with the applicable reference safety information.

ICH E2A frames expedited reporting around adverse drug reactions that are serious and unexpected. The term SUSAR is widely used in clinical trial pharmacovigilance to operationalize that decision.

AE vs SAE vs SAR vs SUSAR

AE

Any untoward medical occurrence in a patient or clinical trial participant, whether or not related to the medicinal product.

SAE

An adverse event that meets a seriousness criterion such as death, life-threatening event, hospitalization, disability, congenital anomaly, or other medically important event.

SAR

A serious adverse reaction: serious plus a suspected causal relationship to the product.

SUSAR

A serious suspected adverse reaction that is also unexpected against the RSI, investigator brochure, SmPC, or other applicable reference.

RSI Expectedness

Expectedness should be assessed against the version-controlled Reference Safety Information for the trial. For investigational products, this is often a defined RSI section in the investigator brochure. For authorized products used as comparators or background therapy, the SmPC, prescribing information, or label may be the relevant reference.

A reaction may be unexpected because it is absent from the RSI, because the severity or specificity is different from what is described, or because the clinical outcome changes the safety meaning of a known reaction.

7-Day and 15-Day Reporting Clocks

The expedited reporting clock is usually counted from the sponsor's first awareness of a valid case with enough information to determine reportability. Clock start can depend on intake workflow, follow-up needed to validate the case, local implementation of ICH principles, and trial-specific SOPs.

Fatal or life-threatening SUSAR Likely 7 calendar days, with relevant follow-up within a further 8 days.

Other SUSAR Likely 15 calendar days.

Not a SUSAR No SUSAR expedited timeline, but SAE, AE, protocol, ethics, or aggregate reporting obligations may still apply.

PV Workflow for Pharma Professionals

SUSAR assessment is a downstream step in clinical trial pharmacovigilance after case intake, MedDRA coding, seriousness triage, and causality review. Sponsors evaluate whether a serious case with suspected IMP relationship is unexpected against the RSI version approved for the trial, then determine expedited reporting to investigators, ethics committees, and regulators within applicable 7-day or 15-day clocks.

A typical workflow: (1) intake and duplicate check; (2) Seriousness Checker for ICH E2A SAE criteria; (3) Causality Assessment for WHO-UMC or company relatedness; (4) expectedness against IB/SmPC RSI; (5) SUSAR determination with this tool; (6) E2B(R3) ICSR and investigator notification per SOP; (7) aggregate review via Signal Detection when disproportionality screening follows case-level work.

Case-level SUSAR decisions are distinct from signal validation. Use ICSR Case Processing guidance for validity, follow-up, and narrative quality alongside this triage helper.

Local Regulation Caveat

ICH E2A provides an international baseline, but clinical trial safety reporting is implemented through local law, regulator portals, ethics committee expectations, and sponsor procedures. Confirm the final reportability decision against the applicable region, protocol, RSI version, and pharmacovigilance SOP.

Evidence & Sources

ICH E2A: Clinical Safety Data Management — Definitions and Standards for Expedited Reporting
ICH E2B(R3) Implementation Guide — ICSR transmission
EU CT Regulation Annex III — Safety reporting timelines
ACRP: Clinical research safety reporting requirements for sponsors and investigators
EMA GVP Module VI — Management and submission of reports
Competitive landscape: Clinical Trials 101 provides authoritative SUSAR definitions, 7/15-day clocks, and inspection-ready workflow guidance—but as an article, not an interactive triage tool. GCP Blog covers ICH E2A minimum criteria and day-0 clock rules in blog format without integrated seriousness, causality, or signal-detection links. IntuitionLabs explains AE vs SAE vs SUSAR differences but lacks expedited timeline output. NovaPharmaNews provides a free interactive SUSAR decision tree with 7-day/15-day timeline prompts and integrated pharmacovigilance hub cross-links—not a replacement for sponsor SOPs or E2B submission.

Frequently Asked Questions

What does SUSAR mean in pharmacovigilance?

SUSAR means Suspected Unexpected Serious Adverse Reaction. In clinical trial safety reporting, it applies when an adverse reaction is serious under ICH E2A, there is a reasonable suspected causal relationship to the investigational medicinal product (IMP), and the reaction is unexpected against the applicable Reference Safety Information (RSI)—such as the investigator brochure RSI section, SmPC, or product label for comparators.

What is the difference between AE, SAE, SAR, and SUSAR?

An adverse event (AE) is any untoward medical occurrence whether or not related to the product. A serious adverse event (SAE) meets one or more ICH E2A seriousness criteria. A serious adverse reaction (SAR) adds a suspected causal relationship. A SUSAR further requires unexpectedness against the RSI. Not every SAE is a SUSAR—expected serious reactions or those without reasonable suspected causality may still require SAE handling without SUSAR expedited reporting.

What are the 7-day and 15-day expedited reporting timelines for SUSARs?

Under ICH E2A principles widely applied in clinical trials, fatal or life-threatening SUSARs are commonly reported as soon as possible and no later than 7 calendar days after the sponsor first becomes aware, with relevant follow-up within a further 8 days. Other SUSARs are commonly reported within 15 calendar days. EU CT Regulation Annex III and local implementation may specify identical or additional rules—always confirm against study SOPs and applicable authority requirements.

How is expectedness assessed against RSI, IB, or SmPC?

Expectedness is assessed against the version-controlled Reference Safety Information for the trial. For investigational products, this is often a defined RSI section in the investigator brochure (IB). For authorized comparators or background therapy, the SmPC, prescribing information, or label may apply. A reaction may be unexpected if absent from the RSI, if severity or specificity differs from what is described, or if the clinical outcome changes the safety meaning of a known reaction.

What minimum case criteria must be present before the reporting clock (day 0) starts?

Before the expedited reporting clock starts, a valid safety case typically needs an identifiable patient, a suspect product, an identifiable reporter, a serious unexpected event or reaction, and enough information to support a reasonable causal relationship—per ICH E2A minimum criteria and sponsor intake SOPs. Incomplete cases may require follow-up before day 0; premature clock start without minimum validity is a common inspection finding.

Is every SAE a SUSAR?

No. An SAE is defined by seriousness criteria alone. A SUSAR additionally requires suspected causality to the IMP and unexpectedness against the RSI. An SAE that is expected per the current IB/SmPC version, or not reasonably related to the suspect product, may still require SAE documentation, ethics notification, or aggregate reporting without triggering SUSAR expedited submission.

When does the sponsor reporting clock start for a SUSAR?

The expedited reporting clock generally starts when the sponsor first becomes aware of a valid case with enough information to determine reportability—often called day 0. Clock start depends on intake workflow, follow-up needed to validate minimum criteria, local ICH implementation, and trial-specific SOPs. Awareness by a CRO, site, or affiliate may trigger sponsor obligations depending on contractual and regulatory definitions of "becomes aware."

How does SUSAR assessment relate to seriousness and causality workflows?

SUSAR triage follows seriousness and causality assessment. First confirm ICH E2A seriousness with the Seriousness Checker, then assess WHO-UMC or company causality with the Causality Assessment helper, then evaluate expectedness against the RSI version in force at the time of the event. After SUSAR determination, aggregate signal review may follow via Signal Detection—case-level SUSAR decisions are distinct from disproportionality screening.

What is the difference between fatal/life-threatening and other SUSAR reporting?

Fatal or life-threatening SUSARs trigger the shorter expedited timeline—commonly 7 calendar days with follow-up within 8 additional days. Other SUSARs without fatal or life-threatening status typically follow the 15-calendar-day timeline. Life-threatening means the person was at immediate risk of death at the time of the event, not merely that a more severe form might have been fatal.

Which Reference Safety Information version applies for expectedness?

Expectedness is assessed against the RSI version approved for the trial and in effect at the time of the event—not necessarily the latest IB amendment received after the event. Sponsors document which IB/SmPC version is referenced in the trial master file and safety management plan. A reaction listed in an older RSI version may be expected even if a newer version would classify it differently.

Does this tool replace E2B(R3) submission or sponsor pharmacovigilance SOPs?

No. This decision tree supports professional triage and training only. Final SUSAR determination, recipient lists (investigators, ethics committees, regulators), clock start, follow-up obligations, and E2B(R3) ICSR transmission must follow current ICH guidance, regional law, protocol, approved RSI, and company pharmacovigilance SOPs. Automated triage cannot substitute for qualified medical review or regulatory sign-off.

Can this SUSAR assessment tool replace medical review?

No. SUSAR classification requires medical and scientific judgment on seriousness, causality, expectedness, and case validity. This tool summarizes common decision points for documentation support. A medical reviewer should reassess when new follow-up changes seriousness, causality, expectedness, RSI version applicability, or minimum criteria—and retain audit trails when classifications change.