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.
Type of Study	• Use this option to specify whether the study is a Clinical or Non-Clinical Study.
the location of either the SDTM or SEND Folder 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:

Note: If your JMP Clinical software has been configured for SAS Drug Development, clicking expands a drop-down menu. Select From Folders from the drop-down menu to open the Add Study dialog.

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Specify the desired options and click Run.

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.
Type of Study	• Specify whether the study is a Clinical or Non-Clinical Study. • Clinical is selected by default. In this case, you can specify both SDTM and ADaM folders as well as selected SDTM and ADaM domains. • If you select Non-Clinical, you can specify only an SEND folder and selected SEND domains.
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.
Use SAS Transport Files	• Raw clinical trial data is frequently transmitted in compressed SAS transport (.cpt or .xpt) files. Check this option to convert the SAS Transport Files into SAS data sets. Version 8 SAS Transport .xpt files are supported. • This option is checked by default.
Enable Future Snapshot Comparisons	Selecting this option enables future snapshot comparisons of study data collected and recorded at different intervals during the study period.
Selected SDTM Domains	• This option is used to specify only selected domains to add to your study when there are multiple SDTM domain files in the same folder. All other domains are excluded. Note: Relationship data sets cannot be excluded and, therefore, are not listed.
Selected ADaM Domains	• This option is used to specify only selected domains to add to your study when there are multiple ADaM domain files in the same folder. all other domains are excluded.
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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Click the Clinical radio button to specify the type of 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.

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Check the boxes to enable use of SAS transport files and future snapshot comparisons.

The completed dialog appears as follows:

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Click Run to add the study.

When a study has been successfully added, the Results: Add Study window opens:

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

Options	Information
Open Duplicates and Keys Report	• Opens a PDF report listing all of the keys and duplicates in each domain in the study.
View Included and Excluded Domains	• Opens a PDF listing all of the domains included in or excluded from the study.
Manage Profile Data	• Opens the Manage Profile Data window.
Set Value Ordering	• Opens the Set Value Order and Color in Studies window.