SAE & SUSAR Management.
For all your clinical trial case reporting needs.

What is Clinical SAE & SUSAR Management?

During a clinical trial, a subject could experience a Serious Adverse Effect from the Investigational Medicinal Product (IMP) being trialled. Depending on any definitive or probable causal relationship between the IMP and the event, the reporting of a case can fall under three categories, SAE, SAR or SUSAR. SAE & SUSAR Management concerns how these differ and how to process them.

Serious Adverse Event (SAE).

An SAE is a specific category of adverse event according to ICH E2A guidelines, which DOES NOT have a causal relationship with an IMP.

SAEs are characterised as any undesirable medical incident that, regardless of dosage, meets one or more of the following seriousness criteria::

  1. Leads to loss of life.
  2. Poses a life-threatening situation. Note that “life-threatening” in this context denotes an event where the patient faced a risk of death when the incident occurred, rather than a hypothetical situation where it might have caused death if it were more severe.
  3. Necessitates hospitalization, either as an inpatient or by extending an ongoing hospital stay.
  4. Results in enduring or substantial disability or incapacity.
  5. Involves a congenital anomaly or birth defect.

During clinical investigations, it’s possible for adverse events to arise that, if suspected to be connected to the medicinal product (referred to as adverse drug reactions), might be significant enough to necessitate substantial changes in the development of the medicinal product.

Such changes could encompass adjustments in dosage, target patient populations, required monitoring procedures, and informed consent forms, among others.

The decision to expedite reporting should be made with medical and scientific judgment. This is applicable in scenarios beyond those outlined above, such as crucial medical events that may not be immediately life-threatening or fatal, nor result in hospitalization, but could imperil the patient or require intervention to avert any of the other outcomes mentioned in the definition. In such cases, these events should generally be regarded as serious.

Within the EEA, trial investigators must report SAEs to sponsors within 24 hours, and if there is probable causality from the IMP, as a SAR or SUSAR.

Serious Adverse Reaction (SAR) and Suspected Unexpected Serious Adverse Reaction (SUSAR).

In the event of a Serious Adverse Event (SAE) occurring with an Investigational Medicinal Product (IMP) that indeed has a probability of a causal connection, and if there exists a certain likelihood that this SAE represents an undesirable and harmful reaction to the IMP, irrespective of the administered dosage, it is categorized as a Serious Adverse Reaction (SAR).

Should this SAR also be unexpected, it is then labeled as a SUSAR, where ‘unexpected’ implies that the nature and severity of the SAR do not align with the safety information provided in the Reference Safety Information (RSI) found in the Summary of Product Characteristics (SPC) text or the Investigator’s Brochure.

All SUSARs must be reported into EudraVigilance within the following time limits:

  • For SUSARs deemed fatal or life-threatening (corresponding to seriousness categories 1 and 2 in the SAE seriousness criteria), the clinical trial sponsor is obligated to report, at the very least, essential information within a maximum of seven days from the time they become aware of the case.
  • SUSARs that are neither fatal nor life-threatening (falling into seriousness categories 3, 4, and 5) must be reported within 15 days.

Additionally, sponsors are also responsible for keeping all investigators updated regarding the safety profile of the Investigational Medicinal Product as it evolves throughout the clinical trial.

Click for full information on the EMA clinical trial reporting guidelines.

Why use Aeigisana’s Clinical Safety team for your SAE & SUSAR Management?

A full reporting service.

For sponsors, or third parties, our Clinical Safety team can process all your trial SAE reporting using our or your database, and of course EudraVigilance for SUSARs.

Our experts have the deep knowledge and expertise to thoroughly assess all your cases, including the use of a physician as required, and to know what to do in each circumstance to ensure you stay fully compliant at all times.

We create confidence.

Our aim is to create trust and confidence and complete peace of mind with clients for the now and the future, from demonstrable competence and efficiency.

We are committed to the highest standards of safety to help you create successful products that protect subjects, and patients.