Standard Safety Reports

This process creates various standard safety tabular reports in rtf , pdf , html , or plain text format.

This process calls a number of SAS programs that are included with JMP Clinical. These program files are located C:\Program Files\SASHome\JMP\10\Clinical\StandardReports . This location is specified, by default, in the Safety Reports Folder field on the General tab of the Standard Safety Reports dialog .

What do I need?

This process requires the subject level analysis data set ( ADSL ) included in the Analysis Data Model ( ADaM ) and domain data sets from the Study Data Tabulation Model ( SDTM , v3.1.1). SDTM domains include Adverse Events ( AE ), Concomitant Medications, ( CM ), Demographics ( DM ), Disposition ( DS ), ECG Test Results ( EG ), Exposure ( EX ), Laboratory Test Results ( LB ), Medical History ( MH ), and Vital Signs ( VS ).

Output/Results

The selected standard safety reports are generated in the specified format ( rtf , pdf , html , or plain text). Refer to the Standard Safety Reports output documentation for detailed descriptions and guides to interpreting your results.

Special Case: Modifying the Reports

The standard reports produced by this process should be sufficient for most purposes. However, your circumstances might require one or more specialized reports. To modify one or more of the reports that are produced by this process, you must modify the corresponding SAS programs that generate them.

Caution : You should not attempt to modify these SAS programs unless you are an experienced SAS programmer.

To modify one or more programs, complete the following steps:

•

Copy all of the program files located in the C:\Program Files\SASHome\JMP\10\Clinical\StandardReports directory and paste the copies in a new directory. All of the program files, even those that are unmodified, must be located in the same folder. Generating a complete second set of files in a new directory satisfies this requirement and ensures that you do not overwrite the standard program files.

•	Modify only those files in the new directory.

•	Make your changes to the desired program files. Save the changes.

Caution : You must not change the names of the SAS program files.

Specify the new directory when you run the Standard Safety Reports process.