Manually select data
Use criteria to select data
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To exclude a data record(s), select the corresponding row(s) in the first table on the page.
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Right-click a selected row and select Exclude from Statistic, Exclude from NCA, or Exclude from PC.XPT from the menu.
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In the popup dialog, enter the reason for exclusion and click OK.
For Exclude from Statistic or Exclude from NCA, when SEND is the standard, use the Include Flag in PC.XPT checkbox to indicate if a column for an exclusion flag should be included in the PC domain file.
For Exclude from PC.XPT, if there are any comments in the CO domain for the selected records, they will need to be removed before the exclusion can be performed.
Note:Use the filter icons beside each column name to aid in the selection of records for manual exclusion.
Filter criteria can also be used to identify the records to exclude.
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When SEND is the standard, use the Include Flag in PC.XPT checkbox to indicate if a column for an exclusion flag should be included in the PC domain file.
For SDTM, concentrations are recorded in the SUPPPC output domain. -
Select where the exclusions are to be applied: Exclude from Statistic, Exclude from NCA, or Exclude from PC.XPT.
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Select the variable on which to base the exclusions.
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Check the box(es) for the operator(s) to use in the criteria. Use combinations of two operators, if needed (e.g., check < and = to indicate the value is “less than or equal to”).
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Type the value in the Enter Value field.
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Enter a reason for the exclusion.
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Click Exclude.
The rows that match the criteria will be shaded pink.
For Exclude from PC.XPT, if there are any comments in the CO domain for the selected records, they will need to be removed before the exclusion can be performed.
Note:Only a single value is supported for the Enter Value field. If multiple values are entered (e.g., a comma-separated list), no exclusions will be applied.
To remove the previously applied exclusion, click the Undo button.
To remove the exclusion of a specific row, right-click the row and select Undo.
Click Clear Criteria to clear the fields and settings made on the page (any rows marked for exclusion will remain shaded).
Use the Save Criteria and Load Criteria buttons to re-use exclusion criteria with a different data set.
For SEND 3.x, the reason is stored in the Master PC worksheet column PCREASEX, and PCEXCLFL=”Y” when the record is excluded from NCA or ExcludeFromPCDomain=”Y” when excluding from PC.XPT. In addition, EXCLCRIT=”Exclusion criteria” when filter criteria are used.
For SDTM 3.2, in the Master PC worksheet, ExcludeFromNCA=”Y” when the record is excluded from NCA or ExcludeFromPCDomain=”Y” when excluding from PC.XPT. In addition, EXCLCRIT=”Exclusion criteria” when filter criteria are used. The reason is not recorded. However, a record is created in the CO domain for NCA exclusions.
When Exclude from NCA is specified, the data records (where the column PCEXCLFL is set to “Y”) will be excluded from NCA_PLASMA_Worksheet or NCA_URINE_Worksheet; but will still be presented in the PC.XPT.
When Exclude from PC.XPT is specified, the data records that are marked as excluded from PC.XPT will be removed when the file PC.XPT is created. The records that are excluded from the PC domain will be included in the NCA_PLASMA_Worksheet and NCA_URINE_Worksheet
