Assessing expectedness of an adverse event

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Presentation transcript:

Assessing expectedness of an adverse event

Assessment of Adverse Events (AEs) Once identified an AE requires up to 4 assessments: Seriousness Severity Causality Expectedness Assessment of AEs should always be made according to the study protocol

Assessing AEs NO Adverse Event (AE) Any untoward medical occurrence in a clinical trial participant, which does not necessarily have a causal relationship with an IMP/intervention. Is it serious? Any AE that at any dose: Results in death of the clinical trial participant Is life-threatening Requires hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability or incapacity Consists of congenital anomaly or birth defect Other significant medical event 3. Was it caused by the IMP/Intervention? Using clinical judgement, knowledge of scientific action and available product information is the AE/SAE possibly to be related to the IMP, NIMP or intervention? AE YES 4. Is it expected? Expected adverse reactions are listed in the Reference safety information (RSI). Only reactions listed in the RSI are expected. (S)AE Unexpected AR/Suspected unexpected SAR (SUSAR) (Serious) Adverse Reaction (AR/SAR) AR/SAR 2. How severe is it? Mild – Easily tolerated causing minimal discomfort Moderate – Sufficiently discomforting to interfere with everyday activities Severe – Prevents everyday activities Serious AE (SAE)

Assessment of expectedness Expectedness assessment is only required if the event is an adverse reaction (possibly related to the IMP/intervention) Expectedness should be assessed according to the approved Reference Safety Information (RSI) There may be more than one RSI if you have more than one medicinal product/intervention in you study

What is RSI? RSI is a list of expected events for the IMP/device/intervention used in the trial What constitutes the RSI for a study should be clear in the safety section of the approved study protocol For CTIMPs the RSI is approved by the MHRA

Examples of RSI For products with a marketing authorisation the RSI is often section 4.8 of the approved summary of product characteristics (SPC) For products without marketing authorisation the RSI is normally contained within a specific section of the Investigators Brochure For medical devices the risk analysis report is often used as the source of expected events

How to assess expectedness Compare the adverse reaction to the approved RSI If the AR is: Not listed in the RSI Listed in the RSI but more severe, common or different in nature to the listed reaction Then it is an UNEXPECTED event

Why is this important? Suspected unexpected serious adverse reactions (SUSARs) are reported by the Sponsor to the MHRA/Research Ethics Committee This allows safety oversight of drugs/devices in use across all clinical trials Incorrect assessment of expectedness can lead to under reporting of SUSARs which could potentially put patients at risk

Require more information? Consult your study protocol If ACCORD sponsor your study consult the safety reporting SOPs on the ACCORD website CR005 – Safety reporting for CTIMPs CR006 – Safety Reporting for non-CTIMPs CR012 – Safety reporting for medical devices Contact us: safety@accord.scot