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Documentation = compliance

Tanshinone regulated gut microbiota and TMAO to improve high-fat diet induced atherosclerosis in APOE-/- mice

Cell 158 , 1524 (2014)

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You need a disciplined set of indicators: AE rate per participant-month (overall and by site) SAE timeliness distribution (not just % on time, but how late and why) Protocol deviation clusters (category + site + recurrence) Query patterns in safety fields (suggesting confusion or under-capture) Lab abnormal trends (outliers and repeated borderline signals) Because data capture quality drives signal detection, you need CRF alignment (CRF best practices) and basic analytic literacy (biostatistics overview)

Acknowledgements This research was supported in part through a University of Michigan Developmental Research/ GI SPORE (P50 CA130810) Pilot Award