Use this field to specify the name and complete path to a new folder containing the Standard Data Tabulation Model (SDTM) domain or Standard for Exchange of Non-Clinical Data (SEND) data for the combined study.
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:
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Adverse Events (ae.sas7bdat),
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Concomitant Medications (cm.sas7bdat),
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Demographics (dm.sas7bdat),
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Disposition (ds.sas7bdat),
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Electrocardiogram (eg.sas7bdat)
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Exposure (ex.sas7bdat),
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Laboratory Test Results (lb.sas7bdat),
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Medical History (mh.sas7bdat), and
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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.
The SEND Folder
The Standard for Exchange of Non-Clinical Data is an implementation of the Study Data Tabulation Model for studies that are not clinical in nature. Refer to the SEND website for additional details about the Standard for Exchange of Non-Clinical Data.
To Specify the New SDTM or SEND Folder:
8
Click and then navigate to the location of the data set.
