SAE and SUSAR Management.
What is an SAE?
An SAE is a Serious Adverse Event, i.e., a type of adverse event – ICH E2A.
A serious adverse event (experience) or reaction can be defined as any untoward medical occurrence that at any dose:
- Results in death.
- Is life-threatening, NOTE: The term “life-threatening” in the definition of “serious” refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.
- Requires inpatient hospitalization or prolongation of existing hospitalization.
- Results in persistent or significant disability/incapacity.
- Is a congenital anomaly or birth defect.
During clinical investigations, adverse events may occur which, if suspected to be medicinal product-related (adverse drug reactions), might be significant enough to lead to important changes in the way the medicinal product is developed such as a change in dose, population, needed monitoring, consent forms and so on.
Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. These should also usually be considered serious.
What is a SUSAR?
A SUSAR is a Suspected, Unexpected, Serious Adverse Reaction, meaning a serious adverse event with at least a reasonable possibility of a causal relationship between the event and the Investigational Medicinal Product (IMP), and is also ‘Unexpected’ meaning ‘an adverse reaction, the nature or severity of which is not consistent with the applicable product information, for example an investigator’s brochure for an unauthorized investigational product, or summary of product characteristics for an authorized product’.
For fatal and life-threatening SUSARs the clinical trial sponsor should report at least the minimum information as soon as possible and, in any case, no later than seven days after being made aware of the case.
SUSARs which are not fatal and not life-threatening are to be reported within 15 days.
Why are SAEs and SUSARs different to other case reports?
As noted above, adverse events which may occur during clinical investigations which if suspected to be medicinal product-related (adverse drug reactions), may also be significant enough to lead to important changes in the way the medicinal product is developed, particularly for reactions which, in their most severe forms, threaten life or function.
Special medical or administrative criteria are therefore needed to define reactions that, either due to their nature “serious”, or due to the significant and unexpected information they provide, justify expedited reporting.
Whilst the term SUSAR is used synonymously with any expedited report, other terminology exists, including the US FDA equivalent IND safety report – CFR 312.32, and slight nuances exist between them in exactly what should be reported, when, and how.
These differences can be subtle, but remain very important for those operating for and on behalf of the clinical trial sponsor in ensuring compliance with local pharmacovigilance legislation. Detailed guidance from the European Commission can be found here ENTR/CT3 revision 3.
How we can help you.
Arriello can support you with all of your SAE and SUSAR reporting through our team of pharmacovigilance experts and specialists, so that you receive the best medical and scientific judgement and advice for your ongoing trial and the continued development of your products.
We are fully experienced in dealing with FDA, EMA and other global and local requirements to ensure you are compliant throughout your clinical trials and beyond.
What our clients say about us.
I have to say that everything has been really smooth with Arriello, and your team has shown a really good disposition since the beginning. Your big experience and knowhow are very important for us also.
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Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
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