Studies

Introduction

A study is a collection of input data folders, settings, and an output folder. Specifically, a study consists of a Study Name associated with one or more data set folders (at least one SDTM or SEND Folder or ADaM Folder must be specified) and zero or more settings, along with a unique Output Folder.

Most JMP Clinical reports require that you specify a study before execution. The chosen study is automatically updated with the output data sets created and the setting that is run. A metadata folder for each study provides a central location for tracking all the reports that have been run, in both the _processinfo.sas7bdat data set and the StudyLog.txt file. A notes folder similarly contains study comment files.

Note: Metadata, notes, and other saved settings are stored in your user home folder. In Windows 7, this is typically C:\Users\<your user name>\AppData\Local\SAS\JMPClinical\14\JMPC\.

See Adding and Manipulating Studies for more information.

Adding and Manipulating Studies

All study additions and manipulations are done on the Studies tab shown below:

Note: For instructions on how to add the Nicardipine example study that ships with JMP Clinical, see Add Study...

Available Studies

All of the registered studies available to you are listed here. Studies can be sorted by various criteria in ascending or descending order.

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Click to select a study. Use Ctrl-click to select multiple studies.

Study Information

Information about the selected study is shown in the panel on the right side of the window. This includes the date the study was created, when it last updated and when it was last accessed. Additionally, the location of the study data within your file structure is shown along with a list of the domains that make up your study data. In the Nicardipine study shown above, there are 3 events domains (AE, DS, and MH), 3 findings domains (EG, LB, and VS) 2 interventions domains (CM and EX), and three special domains (ADSL, DM, and SV).

JMP Clinical can read data from individual domains as well as multiple domains where the study data is split among multiple domains.

Study Operations

Use these buttons to add, manipulate, or delete registered studies.

Add Study: Click to use Add Study...

Combine Studies: Click to combine two studies using Combine Studies . Note: This option remains unavailable unless two studies are selected.

Refresh Study Metadata: Click to update the metadata file for the selected study.

Rename a Study: Click to rename a study.

Change Study Folder Locations: Click to direct the study to a new folder containing the domain data sets. Note: You must manually move the study and data files to the new folders before using this option. Refer to Change Study Folder Locations for more details.

Snapshot History: Click to use Snapshot History to generate a summary report of the snapshot history for the currently selected study

Update Study with New Snapshot: Click to update the selected study with a new snapshot. See Update Study with New Snapshot for more information. Note: This option is available only if the Enable Future Snapshot Comparisons option was checked when you added the Study.

Update Study Risk Data Set: Click to use Update Study Risk Data Set to manually enter site-specific descriptive information as well as risk indicator information

Explore subjects for this study: Click to use the Subject Explorer/Review Subject Filter to generate and filter profiles for selected subjects.

Manage Profile Data: Click to use Manage Profile Data to generate profile data templates and precompute study profiles.

Set Value Ordering in Studies: Click to use Set Value Ordering in Studies to specify the order of values within variable specific plots, such as histograms, and tables as well as the order of value-comparison plots and table within output within plots and tables.

Delete Studies: Click to delete the selected study. After a study is deleted, its notes and reviews folders are copied to \DeletedStudies\study\ directory. The log and result files are moved to \ProcessResults\ directory and the study folder under studies is deleted.