Data Sets Used in JMP Clinical Processes

An important distinction between JMP and JMP Clinical concerns the types of data sets they can use. JMP can open and use data stored in a variety of formats. By and large, however, data sets for JMP Clinical processes must be SAS data sets conforming to the standards set down by the Clinical Data Interchange Standards Consortium ( CDISC ).

The table (below) lists all of the data sets and variables required to run all of the JMP Clinical processes and include the Subject Level Data Set ( ADSL ) from ADaM and the following SDTM domains: Adverse Events ( AE ), Concomitant Medications ( CM ), Demographics ( DM ), Disposition ( DS ), Electrocardiogram ( EG ), Exposure ( EX ), Laboratory Test Results ( LB ), Medical History ( MH ), and Vital Signs ( VS ). All of the data sets must be saved as SAS data sets ( .sas7bdat ).

Data Set/Domain	Variable	Label	Core
adsl	AGE	Age	Required
	USUBJID	Unique Subject Identifier	Required
	AGEGR1	Age Group 1	Preferred
	DEATHDSC	Death Description	Required to run Mortality Cause Comparison .
	RACE	Race	Required
	SEX	Sex	Required
	STUDYID	Study Identifier	Required
	TRT01A	Actual Treatment for Period 1	Preferred
	TRT01P	Planned Treatment for Period 1	Preferred
	TRTEDTM	Date/Time of Last Exposure to Treatment	Required
	TRTSDTM	Date/Time of First Exposure to Treatment	Required
	FASFL	Full Analysis Set Population Flag	Preferred
	SAFFL	Safety Population Flag	Preferred
	ITTFL	Intent to Treat Population Flag	Preferred
	PPROTFL	Per Protocol Population Flag	Preferred
	COMPLFL	Completers Population Flag	Preferred
	RANDFL	Randomized Population Flag	Preferred
	ENRLFL	Enrolled Population Flag	Preferred
ae	AEBODSYS	Body System or Organ Class	Required
	AEDECOD	Dictionary-Derived Term	Required
	AEDUR	Duration of Adverse Event	Required
	AEENDTC	End Date/Time of Adverse Event	Required
	AEENDY	Study Day of End of Adverse Event	Required
	AEREL	Causality	Required
	AESER	Serious Event	Required
	AEOUT	Outcome	Required
	AESEV	Severity/Intensity	Required
	AESTDTC	Start Date/Time of Adverse Event	Required
	AESTDY	Study Day of Start of Adverse Event	Required
	STUDYID	Study Identifier	Required
	USUBJID	Unique Subject Identifier	Required
cm	CMDECOD	Standardized Medication Name	Required
	CMCAT	Category for Medication	Required
	CMDUR	Duration of Medication	Required
	CMENDTC	End Date/Time of Medication	Required
	CMENDY	Study Day of End of Medication	Required
	CMSTDTC	Start Date/Time of Medication	Required
	CMSTDY	Study Day of Start of Medication	Required
	STUDYID	Study Identifier	Required
	USUBJID	Unique Subject Identifier	Required
dm	AGE	Age	Required
	ARM	Description of Planned Arm	Required
	RACE	Race	Required
	RFENDTC	Subject Reference End Date/Time	Required
	RFSTDTC	Subject Reference Start Date/Time	Required
	SEX	Sex	Required
	SITEID	Study Site Identifier	Required
	SAFETY	Safety Population Flag	Required
	STUDYID	Study Identifier	Required
	USUBJID	Unique Subject Identifier	Required
ds	DSCAT	Category for Disposition Event	Required
	DSDECOD	Standardized Disposition Term	Required
	DSSTDTC	Start Date/Time of Disposition Event	Required
	DSSTDY	Study Day of Start of Disposition Event	Required
	STUDYID	Study Identifier	Required
	USUBJID	Unique Subject Identifier	Required
eg	EGBLFL	Baseline Flag	Required
	EGCAT	Category for ECG	Required
	EGDTC	Date/Time of EGC	Required
	EGDY	Study Day of ECG	Required
	EGSTRESN	Numeric Result/Finding in Standard Units	Required
	EGTEST	ECG Test or Examination Name	Required
	EGTESTCD	ECG Test or Examination Short Name	Required
	STUDYID	Study Identifier	Required
	USUBJID	Unique Subject Identifier	Required
	VISITNUM	Visit Number	Required
ex	EXBLFL	Baseline Flag	Required
	EXDOSE	Dose per Administration	Required
	EXDUR	Duration of Treatment	Required
	EXENDTC	End Date/Time of Treatment	Required
	EXENDY	Study Day of End of Treatment	Required
	EXSTDTC	Start Date/Time of Treatment	Required
	EXSTDY	Study Day of Start of Treatment	Required
	EXTRT	Name of Actual Treatment	Required
	STUDYID	Study Identifier	Required
	USUBJID	Unique Subject Identifier	Required
	VISITNUM	Visit Number	Required
lb	LBBLFL	Baseline Flag	Required
	LBDTC	Date/Time of Specimen Collection	Required
	LBDY	Study Day of Specimen Collection	Required
	LBSTNRHI	Reference Range Upper Limit in Standard Units	Required
	LBSTNRLO	Reference Range Lower Limit in Standard Units	Required
	LBTEST	Lab Test or Examination Name	Required
	LBTESTCD	Lab Test or Examination Short Name	Required
	STUDYID	Study Identifier	Required
	USUBJID	Unique Subject Identifier	Required
	VISITNUM	Visit Number	Required
mh	MHBODSYS	Body System or Organ Class	Required
	MHDECOD	Dictionary-Derived Term	Required
	MHSTDTC	Start Date/Time of Medical History Event	Required
	MHSTDY	Study Day of Start of Medical History Event	Required
	MHENDTC	End Date/Time of Medical History Event	Required
	MHENDY	Study Day of End of Medical History Event	Required
	STUDYID	Study Identifier	Required
	USUBJID	Unique Subject Identifier	Required
vs	VSBLFL	Baseline Flag	Required
	VSDTC	Date/Time of Measurements	Required
	VSDY	Study Day of Vital Sign Measurement	Required
	VSSTRESN	Numeric Result/Finding in Standard Units	Required
	VSTEST	Vital Signs Test Name	Required
	VSTESTCD	Vital Signs Test ShortName	Required
	STUDYID	Study Identifier	Required
	USUBJID	Unique Subject Identifier	Required
	VISITNUM	Visit Number	Required

Note : Required variables from all Findings domains are similar to those required for VS , EG , and LB .

Many of the processes in JMP Clinical require only a subset of the variables and data sets, such as AE and LB from SDTM and the ADSL from ADaM , for example. In these cases, you do not have to specify a particular data set; you merely need to specify the SDTM and ADaM folders containing the data sets. JMP Clinical automatically goes to those folders and finds the data.

The CDISC data sets used by JMP Clinical are described more fully at http://www.cdisc.org .