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tranSMART tree Hierarchy is designed as a narrative to Clinical Trial protocol - observations, events and measurements designated as Safety Endpoints are loaded under Clinical Data - Safety Endpoints; assessments, measurements and calculated scores collected and analyzed to assess efficacy are loaded under Clinical Data - Efficacy Endpoints. At the same time, SDTM domains data structure is maintained. Corresponding domain codes are added to the relevant upper level folders (e.g. Adverse Events (AE), Vital Signs (VS),Medical History (MH), etc.). STDM codes are added to Data Labels (e.g. AE by Severity Scale (AESEV), AE by Body System Organ Class (AEBODSYS), etc.) "Narrative" design allows biologists and non-clinical analysts to easily navigate data. SDTM codes can be used to cross-reference tranSMART loaded data with the original data stored in a restricted access clinical trial database. Note that Adverse Events are loaded multiple times to associate each AE "observation fact" with other "observation facts" categorizing Adverse Events.

Example 1 2 Study curated for loading with tMDataLoader (pre-installed on tranSMART 16.2) can be downloaded using the link on this page in the Resources section (2).

Observational Study tranSMART tree

Example 23: tranSMART tree for NEPTUNE Study study

 

Example 2 3 Study curated for loading with tMDataLoader (pre-installed on tranSMART 16.2) can be downloaded using the link on this page in the Resources section (3). NEPTUNE tranSMART tree Ontology file is also attached (4)

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