Data Guidelines

The Safety Histogram accepts JSON data of the format returned by d3.csv(). The renderer visualizes clinical medical signs data with one row per measurement plus the required variables specified below.

Data structure

one record per measurement

Data specification

required and optional variables:

Setting	Default	Data Type	Description	Required?
measure_col	TEST	character	a variable that contains the names of each medical sign	Yes
value_col	STRESN	numeric	a variable that contains the results for each medical sign; non-numeric results are removed with a notification thrown to the log	Yes
id_col	USUBJID	character	a variable that contains IDs for each participant
unit_col	STRESU	character	a variable that contains the units of each medical sign
normal_col_low	STNRLO	numeric	a variable that contains the lower limit of normal of the medical sign
normal_col_high	STNRHI	numeric	a variable that contains the upper limit of normal of the medical sign
filters[]		either	an array of variables and metadata that will appear in the controls as data filters
details[]		either	an array of variables and metadata that will appear in the data listing

Customized Chart with Queries

The following data specs and chart settings can be used to create a chart with several custom filters, including Sex, Race and Query Status. A sample chart using this configuration is found here.

Data Specification

Settings Variable	Variable	Default	Required?
id_col	Participant ID	USUBJID	Y
measure_col	Measure	TEST	Y
value_col	Value	STRESN	Y
unit_col	Unit	STRESU
normal_col_low	Normal Range - Low	STRNLO
normal_col_high	Normal Range - High	STRNHI
filter	Visit	VISIT	Y
filter	Site ID	SITEID	Y
filter	Treatment Arm	ARM	Y
filter	Sex	SEX	Y
filter	Race	RACE	Y
filter	Query Flag ("Y" for yes)	QUERYFL	Y
details	Query Details	QUERYDETAILS	Y

Settings Object

  {filters:
                [   {value_col: 'VISIT',    label: 'Visit'},
                ,   {value_col: 'ARM', label: 'Arm'}
                ,   {value_col: 'SITEID', label: 'Site ID'}
                ,   {value_col: 'SEX', label: 'Sex'}
                ,   {value_col: 'RACE', label: 'Race'}
                ,   {value_col: 'QUERYFL', label: 'Open Query?'}]
            ,details: [
                {value_col: 'USUBJID'     , label: 'Subject ID'},
                {value_col: 'SITEID'      , label: 'Site ID' },
                {value_col: 'SEX'         , label: 'Sex'    },
                {value_col: 'RACE'        , label: 'Race'   },
                {value_col: 'VISIT'       , label: 'Visit'  },
                {value_col: 'DY'          , label: 'Study Day' },    
                {value_col: 'STNRLO'      , label: 'LLN' },
                {value_col: 'STRESN'      , label: 'Result'}, 
                {value_col: 'STNRHI'      , label: 'ULN' },
                {value_col: 'STRESU'      , label: 'Units' },
                {value_col: 'QUERYDETAILS', label: 'Query Details'}]
            }