CDISC Builder™

CDISC

Overview
There are many guidelines that are specified for SDTM version 3.1. It is recommended that the guidelines are adhered by to obtain the most standardized data. This CDISC tool verifies your data against 16 guidelines that is documented on the %cdisc macro reference. A report can be generated upon the selected data pointing out which guidelines your data has deviated from.

CDISC Options
The CDISC screen allows you to select all the options before applying the verification of your data against the CDISC guidelines.

The options available for selecting data for CDISC verification check include the following:

Source Data - This is the location of the dataset that is going to have the CDISC guidelines verification check.
Data Set - The selected dataset that is going to be verified.
Preview - A print out of the first 100 observation of the data
CDISC Data Selection - This button will select all the dataset from the list of data that matches the names of CDISC domains.
Save Code - The code saved in this location will contain a macro call capturing all the options that has been selected. This can therefore be executed independent from this interface as a SAS program.

Multiple datasets can selected before the report can be generated.

CDISC Report
The CDISC report lists all the variables from the selected data containing deviations from the guidelines. An example report looks like:

When the report is first produced, it does not have the "Variable Navigator" at the top. This is added as a post process to view the navigator, you must right mouse click on the report and select the menu item "Refresh". This will then give you the choice of pulling down the menu and selecting the variable that you ant to specifically navigate to.

The comments describe briefly why this particular variable is being reported as a deviation. For more detail, you can click on the case number link. This will link to the reference section of %cdisc which explains in more details why your data is considered to be deviating from the guidelines.