Data Guidelines

The Safety eDish chart is initialized with JSON data files that match the format created by d3.csv(). The chart is specifically designed for clinical trial safety monitoring, and requires a datasets that contains one row per participant per time point per measure and includes the required columns and fields specified below.

Data Standards

The chart expects an SDTM-esque data structure by default but also easily supports the ADaM data standard (Example : Settings, eDish Graphic). Other, non standard data can also be as long as the data is structured correctly.

Required and optional columns and fields for the SDTM and ADaM data standard are given in the tables below

Required Data Columns Settings

Six variables are required to create an eDish plot: ID, Measure, Value, high and low normal range values and study day. Details and suggested values for ADaM and SDTM are given below.

Settings Variable	Description (type)	SDTM (Default)	ADaM	Required?
id_col	Unique Subject Identifier (char)	USUBJID	USUBJID	Y
measure_col	Name of Measure or Test (chart)	TEST	PARAM	Y
value_col	Result or Finding (numeric)	STRESN	AVAL	Y
normal_col_high	Upper Limit of Normal (numeric)	STNRHI	ANRHI	Y
normal_col_low	Lower Limit of Normal (numeric)	STNRLO	ANRLO	Y
studyday_col	Study Day (numeric)	DY	ADY	Y

Optional Data Column Settings

Users may customize the chart with the additional data mappings given below. Note that these are not specified by default, and must be defined by the user. Some suggested mappings for SDTM and ADaM are provided below for reference. See the settings object here for an example of a customized chart.

Settings Variable	Description	SDTM	ADaM	Required?
visitn_col	Visit Number	VISITNUM	VISITNUM	N
visit_col	Visit Name	VISIT	VISIT	N
filter[].value_col	Visit-level filter(s)	SEX, RACE, etc*		N
details[].value_col	Person-level descriptive(s)			N
group_cols[].value_col	Grouping variable(s)	ACTARM*	TRTA	N
baseline.value_col	Baseline Visit definition	DY	ADY	N
analysisFlag.value_col	Analysis Visit Flag	EPOCH	ANL01FL	N

• • merged from demographics data domain.

Data Field Settings

Field level data is used for identifying key measures for the eDish plot (see settings.measure_details) and identifying baseline visits (see settings.baseline). Suggested values (including the default SDTM values) are shown below, but the user should note that these are very likely to change from study to study.

Usage	SDTM Column/Value (default)	ADaM Column/Field Value
Define ALT key measure	TEST / 'Aminotransferase, alanine (ALT)'	PARAM / 'Alanine Aminotransferase (U/L)'
Define AST key measure	TEST / 'Aminotransferase, aspartate (AST)'	PARAM / 'Aspartate Aminotransferase (U/L)'
Define TB key measure	TEST / 'Total Bilirubin'	PARAM / 'Bilirubin (umol/L)'
Define ALP key measure	TEST / 'Alkaline phosphatase (ALP)'	PARAM / 'Alkaline Phosphatase (U/L)'
Define Baseline visit	DY / 0	ADY / 0