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Adverse Events "Unlikely"

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  • Diana
    06/09/2018 09:14
    Hi! I would really appreciate if you can give me your opinion regarding the following issue: if the clinical investigator considers that an adverse event is "unlikely", in the clinical study report should it be reported as "drug related" or "not drug related"? Kind regards, Diana
  • Shaun Hastings
    06/09/2018 12:03
    I am no PV expert but in my experience company SOPs usually prefer the safer option of over-reporting when there is no clear causality, than under-reporting, as it is treated as if no causality was provided by the Investigator but this is usually described within company SOPs. ICH PV E2A states "Many terms and scales are in use to describe the degree of causality (attributability) between a medicinal product and an event, such as certainly, definitely, probably, possibly or likely related or not related. Phrases such as "plausible relationship," "suspected causality," or "causal relationship cannot be ruled out" are also invoked to describe cause and effect. However, there is currently no standard international nomenclature. The expression "reasonable causal relationship" is meant to convey in general that there are facts (evidence) or arguments to suggest a causal relationship". The absence of commitment from the Investigator by using unlikely means a "causal relationship cannot be ruled out" (ICH PV E2A) so in my opinion (and this is just my opinion as am no PV expert) the event should be reported as related.
  • Colin wilsher
    06/09/2018 13:24
    "reasonable causal relationship" is meant to convey in general that there are facts (evidence) or arguments to suggest a causal relationship". Usual English lanague would suggest that "unlikely" could not be "meant to convey in general that there are facts (evidence) or arguments to suggest a causal relationship".
  • Nanda
    06/09/2018 14:08
    Please check the study protocol how "unlikely" has been defined for this specific study. The study protocol should provide guidance on causality assessment for the participating investigators.
  • Anon
    17/09/2018 10:53
    Although specific to cancer, the National Cancer Institute [NCI] do have AE guidelines for investigators which provides adverse reporting requirements and also covers the query you have raised above. The document is abit dated [2012] but does have useful information. Here is the link below: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/aeguidelines.pdf
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