Add Study...

This report adds a study (see Studies) from either local folders or a SAS Drug Development (SDD) server that contain CDISC-formatted data. You must add a study before you can perform the analysis. This report can also import SAS Transport Files for you.

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 Folder and/or the ADaM Folder	• The SDTM or SEND Folder must contain at least one domain. The SDTM Folder option is seen for Clinical trials while the SEND Folder option is seen for Non-Clinical trials. • 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 SAS data sets or SAS Transport Files. • The same folder cannot be specified in the SDTM or SEND Folder and ADaM Folder fields.

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	• If you specify Clinical as the Type of Study, this option is labeled SDTM Folder. If you specify Non-Clinical, this option is labeled SEND Folder. • Use the text box to specify the location and name of the folder. • The SDTM or SEND 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 SAS data sets or SAS Transport Files. • The same folder cannot be specified in the SDTM or SEND Folder and ADaM Folder fields. • For studies with split domains, the split domains must either be in the same SDTM folder as the other domains or must be located in a subfolder called split that is located within the SDTM folder. For more information, please refer to How does JMP Clinical use data contained across split domains?
ADaM Folder	• The ADaM Folder must contain at least one domain. • Either ADDM or ADSL must be present. • Data sets can either be SAS data sets or SAS Transport Files. • The same folder cannot be specified in the SDTM or SEND 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, if you do not explicitly specify which SDTM and ADAM domains to include, 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.

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:\Program Files\SASHome\JMPClinical\14\LifeSciences\Sample Data\Nicardipine). In this example, we add a clinical study we call Nic1.

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