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 ) domain or S tandard for E xchange of N on-Clinical D ata (SEND) data for the combined study.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.
• Adverse Events ( ae.sas7bdat ),
• Concomitant Medications ( cm.sas7bdat ),
• Demographics ( dm.sas7bdat ),
• Disposition ( ds.sas7bdat ),
• Electrocardiogram ( eg.sas7bdat )
• Exposure ( ex.sas7bdat ),
• Laboratory Test Results ( lb.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 .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.The method used for this specification can vary depending on whether JMP is connected to SAS on your local machine or connected to SAS on a server. You should refer to the Specifying Folders, Files, and Data Sets documentation for detailed information.
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