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 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.
Note: SAS data sets (.sas7bdat files) used for submission must have UTF-8 encoding.
The following table summarizes the minimum requirements of new studies.
Either DM (DM in SDTM or ADDM in ADaM) or ADSL (from ADaM) must be present.
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For DM or ADSL, either the treatment start date variable or reference start date variable must be available.
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For ADaM BDS Findings data, both PARAMCD and either AVAL or AVALC must be present.
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Data sets can either be JMP data tables, SAS data sets, SAS Transport Files, Dataset-JSON files or a combination of these.
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Where JMP Clinical allows users to specify a path to a study input data folder, the SAS V8 Transport File Format (.v8xpt, .xpt8, .stx, .2xpt) is one of several accepted file formats. When the folder contains duplicate filename stems, the general priority (from highest to lowest) for choosing an extension within each stem is:
This option is used when there are multiple SDTM domain files in the same folder.
Use this option to specify the SDTM domains to be added to the study. If you leave this option blank, all SDTM domains in the folder are added to the study.
This option is used when there are multiple ADaM domain files in the same folder.
Use this option to specify the ADaM domains to be added to the study. If you leave this option blank, all SDTM domains in the folder are added to the study.
Load Only
This setting applies to Findings results submitted in SDTM.
Choose to import either:
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Results in standard units (data is imported from xxSTRESNor xxSTRESC).
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Results in original units (data is imported from xxORRES).
Start Date Imputation Method:
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Use Start Date Imputation Method to specify whether to use the first moment rule or last moment rule for deriving missing values in the variable indicating the starting day of an event/finding/intervention.
End Date Imputation Method:
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Use End Date Imputation Method to specify whether to use the first moment rule or last moment rule for deriving missing values in the variable indicating the ending day of an event/finding/intervention.
Value Derivation
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The Value Derivation widget enables you to derive values for any missing study day data or to rederive all study day values across the study, replacing any existing values
Checking this box makes your study the default study for all reports. This option is checked by default.
Close this window after adding study
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Checking this box closes the Add Study window once the study has been added.. 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.
Note: You should make sure that JMP Show Alternate Column Name preference (File > Preferences > Tables > Show Alternate Column Name)is not checked. If checked, this option results in the original column names, such as USUBJID, being lost when the study is added.
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 and navigating to the folders.
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Accept default setting for all other options.
The completed dialog appears as follows:
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Click 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.
The Internal Data Model
During the Add Study process, a number of variables from the imported data sets are used to construct a new set of internal JMPC_ variables. These analysis-ready variables follow the ADaM standards and they are used in calculations and displays by the reports. Some of these variables only get added to the TADSL data table which is an internal subject-level data table that is a merge of ADSL and DM, if both exist. For those cases in which a variable exists in both ADSL and DM, the ADSL variable takes priority over the DM variable. If ADSL is present, but DM is not, TADSL is based only on ADSL. Conversely, if DM is present but ADSL is not, then TADSL is only based on DM.
The JMPC_ variables have the following column properties:
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SAS Name – same as column name.
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SAS Label – the label of the original variable is used. If the variable was derived and multiple variables were used to create the variable, then the standard ADaM label is used.
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Origin – this is the list of the original variable(s) that was/were used to create the JMPC_ variable.
to open the dialog:
