Recommendation	Rationale
For overall timeliness in quantitative signal detection, analysis can be performed at the MedDRA® PT level	The PROTECT study found no advantage in conducting signal detection at levels of MedDRA® above the PT level and indeed observed a net loss in timeliness of quantitative signal detection from replacing an analysis at the PT level with one at a higher level of the hierarchy [9]
Future research should evaluate the false-positive burden for signal detection at each level of the terminology	The false-positive burden was out of scope for the PROTECT study [9]
Future research should evaluate tighter custom-made groupings of MedDRA® PTs for signal detection	Neither PTs nor HLTs are universally ideal for quantitative signal detection. Gains in time by aggregating PTs were observed in the PROTECT study when the terms were very similar, in a clinical sense [9]
Future research should evaluate simultaneous analysis at different levels of the terminology	Parallel analyses at different terminological levels could improve timeliness but have resource implications [9]
Future research should explore a broader range of ADRs	The PROTECT study was restricted to a selection of 13 ADR categories [9]