Appendixes | Report Option Descriptions | New SDTM Folder

New SDTM Folder
Use this field to specify the name and complete path to a new folder containing the S tandard D ata T abulation M odel ( SDTM ) domains.
The SDTM Folder
The Study Data Tabulation Model defines a standard format for reporting the results generated during clinical trials. Observations included in the SDTM must be reported, as collected, in clean, raw form. No derived values are reported in the SDTM. Observations are grouped by specific topic into individual SAS data sets, or domains . Refer to the SDTM website for additional details about the Standard Data Tabulation Model.
SDTM domains used for analysis in JMP Clinical include:
Adverse Events ( ae.sas7bdat ),
Demographics ( dm.sas7bdat ),
Disposition ( ds.sas7bdat ),
Electrocardiogram ( eg.sas7bdat )
Exposure ( ex.sas7bdat ),
Medical History ( mh.sas7bdat ), and
Vital Signs ( vs.sas7bdat ).
Note : All SDTM domains must be placed in the same folder prior to analysis with JMP Clinical. This folder should be named SDTM .
To Specify the New SDTM Folder:
Click Choose and then navigate to the location of the data set.
To View the Contents of the Specified Folder:
Click Open .