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19th Jan 2018, 12:54 PM
#3
Thank you for the question Mozza
You are correct, and perhaps on next review I should put a line back to Exclude - not an SAE.
To clarify, this flow diagram is one to illustrate the MHRA thought process and assessment. It is adapted from a very similar flow diagram for the reporting of SAEs in a previous guide when the SABRE and SHOT databases weren't linked. I made the changes as I didn't want reporters to go through the flow diagram and not report things which were previously described as "SHOT only" reports. For example, a WBIT is still reported on SABRE, but because it doesn't meet the criteria of a BSQR SAE, I exclude it.
Obviously a reporter can use the flow diagram to see if an event is likely to be seen as an SAE by MHRA, but I do not want reporters under-reporting to SHOT.
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