Steps

  1. Start a new SAS session.
  2. In the SAS Program Editor, select Filethen selectOpen Program, and then select CST_FRAMEWORK/programs/validate_iqoq.sas.
  3. Select Runthen selectSubmit.
    The program outputs to the SAS log and creates a cstrslt.validation_results data set under CST_FRAMEWORK/results.
    Note: The SAS log might reach its limit depending on your system options. If it does, print the contents to a file, and select APPEND in the pop-up menu. This can happen several times during the run, so be sure to append each time it happens. To maximize the log size, you can add the option –DMSLOGSIZE 999999 to the SAS configuration file.
  4. If the SAS log reaches it limit, perform these steps:
    1. In the pop-up window, select F to file.
      Log Window Full window
    2. Enter a filename, and select APPEND or REPLACE.
      Note: Select REPLACE for the first occurrence of the pop-up window only.
      Filename window
    3. Click END.
    4. Repeat steps a through c until finished.
      Use the same filename each time, and select APPEND.
  5. Review the log to see whether there are any errors or warnings.
    There should be no errors or warnings.
  6. The column labeled Process status (named _cst_rc) is 0 for all records.
  7. Review the cstrslt.validation_results data set using the SAS explorer, especially for the following conditions:
    1. The field resultflag is not 0.
      When this value is not 0, a potential problem might exist. To more easily check this value, subset the validation_results data set by entering where resultflag ne 0 in the control box in the upper left:
      where resultflag ne 0 in the control box in the upper left
    2. A number of observations can have result flag=1.
      If the resultseverity column is Note, these values are acceptable. To more easily check these values, subset the validation_results data set by entering where resultflag = "Note" (this is case sensitive) in the control box in the upper left:
      where resultflag = “Note” in the control box in the upper left
      Here are examples of where resultseverity="Note" and resultflag ne 0:
      • In this example, multiple records are detected because there are multiple standard versions for ODM (1.3.0 and 1.3.1) and SDTM (3.1.1, 3.1.2, and 3.1.3). If multiple records were found for the same standard version, this check would be in error.
        multiple records are detected
      • In this example, a check was not run because the check is not applicable to this standard. An informational check informs you that check CSTV251 is not applicable to this standard.
        check CSTV251 is not applicable to this standard
      • In this example, a check was not run because the check has not yet been implemented in the SAS Clinical Standards Toolkit. Check CSTV262 included with the SAS Clinical Standards Toolkit has not yet been implemented in this release. Therefore, the check did not run.
        check not yet implemented in the SAS Clinical Standards Toolkit
      • In this example, these data sets are empty. They are empty because they are templates and do not contain observations.
        data sets are empty
      • In this example, resultseverity equals Info because the controlled terminology does not have an sl_cntl folder associated with it. There are no control type data sets associated with controlled terminology.
        resultseverity equals Info
        No observations should appear when you enter where resultseverity = "Error" in the control box in the upper left.
        resultseverity equals Error
  8. Close the SAS session.
Running the validate_iqoq internal validation program without error confirms that all metadata is in place, all files are in place, and all access (whether Read or Write) to the SAS Clinical Standards Toolkit is properly initialized. This process has ensured that the installation of the SAS Clinical Standards Toolkit was done properly and that the key components are operational.
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