Process Validation Rules

Process Validation Rules (formerly Reference Rules) in Greenlight Guru Clinical allow question answers to be conditioned/validated by question answers in different forms or data events. It is possible to have rules on dates, such that visit dates in a later data event cannot be before visit dates in an earlier data event.

Three types of actions:

• Block Answer: Will block the form from being saved, so long as the answer breaks the rules.
• Show Warning: Will allow the answer to be saved but will display a warning text in orange color. The warning text can be specified by the user, if nothing is specified it will use a default text.
• Generate Query: Will create a query on the answer, and notify anyone with the “Query Permission”. The creator of the query will be denoted as “System generated query”

The table below specifies which question types can be used to create references and which question types they can create a reference to. We will continuously add rules so if you have any additional rules you would like to be able to set up, please contact: clinical.support@greenlight.guru

How to set up Process Validation Rules:

Reference rules are setup step-by-step and follow the form of:

If the answer in question X is greater/smaller than the answer in question Y, then Do Something.

The rules will not work until data is present in both of the questions,  so if you have marked one of the two questions as “not available” the rule will be ignored.

Before setting up the rule in Greenlight Guru Clinical, it can be a good idea to write down the rule, to ensure it ends up doing what you want. This is because it can quickly become confusing when the rule is actually triggered. Please remember that the rules can work both ways, in the sense that: if A is greater than B, is the exact same as if B is less than A.

1. Using the left-side menu go to [Study Name] --> Process Rules.
   
   
   
2. Select "Validation" and click on + RULE.
   
   
   
3. Now you can the Process Validation Rule.

Note: You can only setup one rule at a time, therefore if you wish to make a range, it requires two validation rules.

Offset

The offset can be used if the value of the one question should have a numeric value/ a number of days added to its value.

Could be that there should be at least 7 days between visit 2 and visit 1, in that case, the offset would be set to 7 days. That way if the user tries to enter a date value that is less than 7 days after visit 1, they will be notified.

Process Validation Rules list

The Process Validation Rule list will show you the "If the answer from" information. You will have to click on "View" (the eye icon) to see the "is" and "then" information.

If a rule is marked with red, it is invalid and should be corrected prior to start the study.

Filter Options

The "Filters"-button can be used to identify specific Process Validation Rules of interest. The filter options include:

• Identifier - the unique number each process validation rule receives.
• Process Name
• Data Event Name
• Form Name
• Question Text
• Action Type

You can combine multiple filters at the same time to specify the search. Multiple filters will interact in an AND capacity with other. 

Customize Columns

The Process Validation Rules table can be customized by dragging the columns to rearrange the order of these and via the "Columns"-button, where you can select/deselect columns.

Examples of Process Validation Rules

Please note there often are multiple ways to create process validation rules that have the outcome. Hence, the following examples will not be the only process validation rules that can be used for the desired outcome.

Example 1 - Compare Dates for Specification of Visit Window

In example 1, the Follow Up Day 30 form should be completed 30 days (+/- 1 day) after the Medical History form was completed. This is controlled by comparing the "Visit date" question of the Medical History form with the "Visit date" question of the "Follow Up Day 30" form. To specify a visit window, two different process validation rules need to be created: one for the upper range and a second for the lower range.

Upper range - anything above 31 days triggers the warning to appear:

Lower range - anything below 29 days triggers the warning to appear:

Example 2 - Compare Numbers for Specification of Visit Window

In example 2, the Vital signs form has to be completed for both the Baseline Visit and for the Follow Up Day 30 Visit. If the answers for the number question, Heart rate, differ with more than 20 between the two visits, the system should generate a query for the site personnel telling them to report an adverse event.

To specify the range (+/- 20), two different process validation rules need to be created: one for the upper range and a second for the lower range.

Upper range: 

Lower range: