Expectedness Assessments Of SAEs – Who Does Them?

This may have come up in previous discussions but who at your CTUs carries out expectedness assessments of SAEs? Currently we ask our SAE reviewers to perform them and these people are all external to our CTU and usually medics.

However, we are wondering if it would be less time consuming and simpler not to ask the SAE reviewer to perform the expectedness assessment but instead for the safety officer/PV officer at the CTU to do it.

Regs state person doesn’t need to be medically qualified to perform the assessment. However, we are concerned that if we take this approach we still need medical judgement on SAEs in case they are ‘more severe or prolonged than expected’ as this assessment needs medical judgement.

We are wondering if this point would be covered by the grades against the preferred terms in the RSI, but then thought this may cover the severity but not the prolonged nature of an event. What do other CTUs do in terms of person who performs expectedness assessment please, any information would be helpful. Thanks.

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