Add Study...

This study management action adds a study (see Studies) from local folders that contain CDISC-formatted data. You must add a study before you can perform the analysis. The data can be submitted as JMP data tables (.jmp files), SAS data sets (.sas7bdat files), SAS Transport Files (.xpt files), or a combination of these.

Note: If you are adding JMP data tables, then all columns must have both a SAS Name column property. The columns should also have SAS Label column property, but this is optional. If SAS Label property is provided, then that is used to identify columns in the report displays.

The following table summarizes the minimum requirements of new studies.

You must specify...	...while abiding by these restrictions:
a Study Name	• The study name must conform to the Rules for Study Names.
the location of either the SDTM or SEND Folderand/or the ADaM Folder	• The SDTM or SEND Foldermust contain at least one domain. • The ADaM Folder must contain at least one domain. • Either DM (DM in SDTM or ADDM in ADaM) or ADSL (from ADaM) must be present. • For ADaM BDS Findings data, both PARAMCD and either AVAL or AVALC must be present. • Data sets can either be JMP data tables, SAS data sets or SAS Transport Files or a combination of these. • The same folder cannot be specified in the SDTM or SEND Folderand ADaM Folder fields. • The file path to these folders must conform to the Rules for Paths

The study and associated metadata are added to your database.

To Add a Study

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Click to open the dialog:

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Specify the desired options and click Create.

The following options are available. Links to specific documentation for each of the options are provided in the following table:

Options	Information
Study Name	• The study name must conform to the Rules for Study Names.
SDTM or SEND Folder	• Use the text box to specify the location and name of the folder. • The SDTM Folder must contain at least one domain. • DM must be present. • For ADaM BDS Findings data, both PARAMCD and either AVAL or AVALC must be present. • Data sets can either be JMP data tables, SAS data sets or SAS Transport Files or a combination of these. • The same folder cannot be specified in the SDTM Folder and ADaM Folder fields.
ADaM Folder	• The ADaM Folder must contain at least one domain. • Either ADDM or ADSL must be present. • Data sets can either be JMP data tables, SAS data sets or SAS Transport Files or a combination of these. • The same folder cannot be specified in the SDTM Folder and ADaM Folder fields.
Make this the current study	• Checking this box makes your study the default study for all reports. This option is checked by default.

Note: When adding a clinical study and assigning both ADAM and SDTM domains, the ADAM equivalent of each domain is added and the corresponding SDTM data set excluded. For example, if both ADAE and AE are present, then ADAE takes precedence and is included, whereas AE is not included.

Note: Any SDTM SUPP-- domains are merged into their parent domain.

Note: If some data files cannot be processed, they are excluded from the study. The name of these files with the reason why they were excluded is then listed in the Included and Excluded Domains pdf file.

Note: Empty columns are removed from each domain. The list of these excluded columns is then listed in the Excluded Variables pdf file.

Example: Adding the Nicardipine Study

JMP Clinical ships with the data from a Nicardipine study. The data files are located in the Sample Data in your Installation directory (typically C:\ProgramData\SAS\JMPClinical\17\Clinical\Sample Data\Nicardipine for Windows machines and /Library/Application Support/JMP/17/Clinical/Sample Data for MACs).In this example, we add a clinical study we call Nic1.

Note: The C:\ProgramData\ directory may be hidden by default. Click View > Show > Hidden Items to view.

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Click to open the Add Study dialog.

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Specify the name of the study.

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Specify the file paths to the SDTM and ADaM folders either by typing the path directly or clicking Browse... and navigating to the folders.

The completed dialog appears as follows:

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Click Create to add the study.

When the add study process is complete, the following Results window appears.

When a study has been successfully added, the new study appears in the Studies window.