By defining a time deviation rule, the user can identify sample data where the collection time deviated more than a specified tolerance of time. That tolerance can be set as a length of time or a percentage of time deviation. For example, in the following image, the default rule will flag any samples with a time deviation greater than or equal to 30 minutes or a percent time deviation greater than or equal to 10%. When a rule is broken, a flag is set in the DeviationRuleApplied column.
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From the Data Exclusions and Comments page, click Time Deviation Rules at the bottom of the page.
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Select the columns that contain the Sample Collection Date Time, Dosing Date Time, and Nominal Time data from the menus.
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If needed, click the right arrow circle button and type the format of the data in the Enter Date Time Format field (e.g., MM/DD/YY HH:MM:SS).
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For each deviation (row), specify the following:
Name: Enter a name for referring to the deviation rule.
Lower: Check the Is Specified box to display tools for setting a lower nominal time limit.
Upper: Check the Is Specified box to display tools for setting a upper nominal time limit.
Rules: Enter an amount of time in the Deviation field and/or a percentage in the Percentage field with which to compare the sample time data. -
Use the Add Rule button at the bottom to add another row to the table.
Time deviation is computed as:
•For amount of time deviation (reported in the Deviation PK column):
Sample_Collection_DateTime – (Dosing_DateTime + Nominal_Time)
•For percentage of time deviation (reported in the Percent Deviation column):
[(Amount_of_Time_Deviation)/Nominal_Time] * 100
