The Conditional Action type “Validation” allows users to validate a field’s value based on the field type and the data the field contains or does not contain. This is commonly known as an edit check and will cause an automatic query to be generated when the defined condition(s) are not met. When the validation is triggered, a red error message is also displayed next to the field in the form as displayed in the following figure. As shown below, the Validation Conditional Action states:  If the Current Status Field is answered, “Resolved” and the Date Resolved is, “Blank” then display the error message on the field, “Date  Resolved is a required field”.




A typical conditional action on a number field is if a number value entered falls outside of a range of numbers.  Clinical Studio makes it very easy to evaluate if a value is outside of a range of numbers. The two examples below show how different error messages would result when Systolic Blood Pressure ranges are used; first, when a Validation using the min/max feature is entered, and; second, when a traditional Conditional Action statement has been placed on the field. 


Validation Using the Min/Max Feature

The Min and Max fields represent the acceptable range values that can be entered into a field.  For example, if the Min is set at 50 the field will display an error message stating, “Value violates low range (50)” when the value entered is less than 50.  To capture range notifications a validation like the one shown below can be entered.

To set a single set of ranges for the Systolic Blood Pressure:

1.  Click the “Required” check box in the Validations section of the Number Properties. Then click on the Systolic Blood Pressure number field as shown in the figure below.



2.  In the Number Properties, below the “Required” check box in the Validations section, click in the first Valid Range box (min) as shown in the following figure. 

 

3.  Type in the number 90 to indicate this is the minimum number in the range. Then click in the second box (after the word “to”) and type in the number 140 to indicate this is the maximum number in the range. The Valid Range (min/max) field should look like the figure below.



A simple range has now been set so that when a User completes the Systolic field and the values are outside of this range the field will display an error stating, “Value violates high range (140)” as shown in the following figure.



In this case it is not necessary to write a conditional action. However, if the field is enabled and required based on another field’s answer or multiple validation conditional actions based on different range values, validations would need to be written for each of those messages.  Remember, these are only examples and the validation conditional action can be used for many different situations to make Users aware of an event.  Just remember that the Validation Conditional Actions displays the error message next to the field.

Validations Using a Traditional Conditional Action Statement

As stated above, it is not necessary to write a conditional action when using the Valid Range (min/max) feature. However, a form designer may choose to forgo use of the feature and instead create a traditional conditional action statement for any number of reasons. The example below explains how to create a conditional action statement that displays will display an error message if the range value is low for the systolic pressure (Hypotension).  For this example the Valid Range information was removed but the “Required” check box is left checked.  This ensures that if the user does not complete the field, when the form is saved, a red error message will display stating, “This Field is required” as shown in the figure below. The one exception to this rule is if the field is disabled or hidden, then the field is no longer required. 



To create a traditional conditional action on the field indicating low systolic pressure perform the following steps:

1.   Select the Systolic pressure field and click the conditional actions 0-View/Edit link as shown in the following figure.



2.   This will open the Conditional Action Builder.  In the Conditional Actions Builder click the type drop down and select Validation as shown below.



3.      Click in the Error Message text box and type in the error message. This is the message that will display next to the field when a number outside the range is entered. For this example the text, “Systolic Pressure indicates low blood pressure (Hypotension).  Please report this indication on a Protocol Deviation” was entered as shown in the following figure.



4.   At the bottom of the Conditional Action Builder, Click Block and then click the Insert Last icon as shown in the figure below.



5.   Click Condition and then click the Insert Into icon as shown in the figure below.



6.   The Conditional Actions Builder should look like the figure below.



7.   Click the criteria drop down, scroll down and select the appropriate field. For this example, “SB_SYSTOLIC8A” was selected as shown in the following figure.



8.   Click the “equal” drop down and select “not blank” as shown in the following figure. Notice the second “(criteria)” field disappears when “not blank” is selected. Selecting “not blank” ensures the user must enter a value in the field for the conditional action to be evaluated.



9. Now click the “Insert After” icon as shown below.



This will insert the next condition “And / Or” as shown below.



10.  Click the next criteria drop down, scroll down and select the appropriate field. For this example,  “DB_SYSTOLIC8A” is again selected as shown in the figure below.



11.  Click the “equal” drop down and select “greater than or equal” as shown below.



12.  Click the criteria drop down and select “Number” as shown in the figure below.



This displays a blank field next to the “Number” field as shown below.



13. Click in the blank field and type in the desired number. For this example, the number “50” is entered as shown below.



14.  Click the “Insert After” icon as shown below.



15. Click the criteria drop down, scroll down and select the desired field. For this example the field “DB_SYSTOLIC8A” is selected.

16. In the “equal” drop down select “less than”.

17. Click the criteria drop down and select “Number”.

18.  Click in the blank field next the number field and type in the desired number. For this example, the number “90” was entered.  The completed conditional action should look like the figure below.



19. After completing the expression, click the “OK” button and click the “Save Form” button in the Form Builder.

A conditional action that evaluates the Systolic field value has now been created.  It states, “If the systolic field is not blank and the value is greater than or equal to 50 and less than 90, display the error message, “Systolic Pressure indicates low blood pressure (Hypotension).  Please report this indication on a Protocol Deviation”.

The following figure displays how the field and error message would appear in the actual form:

Another example of a Validation Conditional Action could be written to warn or alert the user that the “end date” entered occurred before the “start date” that was entered occurred.

The Procedure Form in the Study Form Builder application is used for the following example.  To write this conditional action use the Beginning Date and Time of Procedure and Ending Date and Time of Procedure:

1.   Click the Ending Date and Time of Procedure field as shown in the following figure.



2.   Click the “0-View/Edit” next to Conditional Actions as shown below.



3. In the Conditional Actions Builder, click the type drop down and select Validation.

4.   In the “Error Message” box enter the desired error message. For this example, “End time cannot precede Start time. Please correct your data” has been entered as shown below. 



5.   Next, click the “Condition” icon and then the “Insert Last” icon as shown below. Since a single condition is being created a “Block” does not need to be inserted.  However, the Conditional Action would still work if a “Block” was inserted.

6.   Click the “(criteria)” dropdown, scroll through the field list and select the desired field. For this example, “PR_END_DATE” is selected as shown below.

7.   Click the “equal” drop down and select “less than or equal” as shown below.

8.   In the second “(criteria)” drop down select the desired field. For this example, PR_START_DATE is selected as shown below.

The completed conditional action expression would appear as shown in the following figure.

The Conditional Action validation says, “If the Procedure End Date and Time of Procedure is less than or equal to the Procedure Start Date and Time of Procedure”, then display the error message, “End time cannot precede Start time. Please correct your data.”

9. Click the “OK” button at the bottom of the Conditional Actions Builder and then click the “Save Form” button in the Form Builder.

The figure below shows how the Error message would be displayed next to the field if the Ending Procedure Date and Time is before the Beginning Date and Time of Procedure:







Override Query Deployment

A unique function in Clinical Studio is the ability to override query distribution for every validation. By default, queries are deployed to specific roles as defined in the study configuration. However, each validation can be designed so when the edit check is triggered (e.g. A number is out of range), the resulting automatic query ignores the default query distribution. 

In the example below, a validation (edit check) is set up on a field to only send a query to the Data Manager if the validation is triggered. This will override the normal query distribution which is set to go to the Data Manager and the Monitor. 


 



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