PROC CDISC

Overview
 This tool provides a graphical user interface to PROC CDISC which is a SAS procedure used to import and export XML documents in CDISC ODM (Operational Data Model) and SDTM (Study Data Tabulation Model) format.  PROC CDISC provides features such as:

  • Verifies that all required variables are present in the data set 
  • Reports as an error any variables in the data set that are not defined in the domain 
  • Reports a warning for any expected domain variables that are not in the data set 
  • Notes any permitted domain variables that are not in the data set 
  • Verifies that all domain variables are of the expected data type and proper length 
  • Detects any domain variables that are assigned a controlled terminology specification by the domain and do not have a format assigned to them
  • Verifies that all required variable fields do not contain missing values 
  • Detects occurrences of expected variable fields that contain missing values 
  • Detects the conformance of all ISO-8601 specification assigned values; including date, time, datetime, duration, and interval types 
  • Notes correctness of yes/no and yes/no/null responses  

PROC CDISC Options
The PROC CDISC screen allows you to select the source data and related options which is used in updating or validating the XML data for the specified model.  The data flow for this tool is shown here.

Source Data

CDISC Builder
PROC CDISC

  • Reports documenting invalid XML values.

  • Create SAS Dataset containing data model.

  

The options for the two models ODM and SDTM are slightly different.  Currently, the procedure has more options for ODM since this has been more thoroughly defined to the CDISC.  Some options on one model will not be available on the other.  This is shown by being grayed out.

Shared Options

  • Source Data - This is the location of the dataset that is used as input.  Even though this is expected in SAS Dataset format, this can input XML files but converts this to SAS dataset format while processing the information.
  • Preview - A preview of the first 100 observations of the data that is selected.
  • Model - This provides the option of selecting ODM or SDTM.  Depending on the model selected, different options will be made available.
  • Global Variables - specifies general summary information about the study.
  • Basic Definition - Specifies information about the measurement units that were used in the study.  This is optional for exporting CDISC ODM.
  • Presentation Data - Specifies information about how the study is presented to users. This is optional for exporting CDISC ODM.
  • User Data - Specifies information about a user of a clinical data collection system such as an investigator or data management staff member.   This is optional for exporting CDISC ODM.
  • Location Data - Specifies information about a physical location.  This is optional for exporting CDISC ODM.
  • Signature Data - Specifies information about the signature that is stored in the CDISC ODM document. This is optional for exporting CDISC ODM. 

  • Output - The resulting data model stored as a SAS dataset.

ODM Options

  • Model Version - The current version supported for ODM is version 1.2.  The latest version for SDTM is 3.1.
  • Format Active - This specifies whether CDISC ODM code list elements, which contain instructions for transcoding display data in a CDISC ODM document, are to be converted to SAS variable formats, and vice versa.  In an import operation, when this is set to YES, it will convert CDISC ODM code list elements to the corresponding SAS format.  
  • Format No Replace - This specifies whether to replace existing format entries in the format catalog search path in case where an existing format entry has the same name as a format that is being created by PROC CDISC when it converts a CDISC ODM code list element.  When this is set to YES, the procedure does not replace existing formats that have the same name.

SDTM Options

  • Domain - The CDISC procedure currently supports 15 of the 23 SDTM domains. These include:
    Supported SDTM 3.1 Domains DOMAIN CATEGORY
    Demography DM Special
    Comments CO Special
    Concomitant Medications CM Interventions
    Exposure EX Interventions
    Substance Use SU Interventions
    Adverse Events AE Events
    Disposition DS Events
    Medical History MH Events
    ECG Test Results EG Findings
    Inclusion/Exclusion Exception IE Findings
    Laboratory Test Results LB Findings
    Physical Examinations PE Findings
    Questionnaires QS Findings
    Subject Characteristics SC Findings
    Vital Signs VS Findings
Additional SAS Documentation on PROC CDISC is available as shown here:
    CDISC Builder - CDISC Data Tools Software,  Meta-Xceed Inc.© 2009
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