You can create template edit checks to add and define specific attributes about each object (trial, site, patient, visit, form, group, item, and CodeList).
To add a template edit check:
1. Identify and create the necessary template parameters (lists). (See Add a Template Parameter for guidance.)
2. Access the Template Edits page. (See View Template Edits for guidance.)
3. Click the Add Template Edit button.
4. Enter/select the applicable information in the Template Edit page. (For guidance, refer to steps 5-10 under Add a New Edit Check to an Object).
In the following example, the forms are hidden when VISITND is checked (not Empty). Don’t be concerned about the specific form or visit being referenced, because eventually these values will be using parameters.
5. Click the Parameters tab on the left. The list of existing template parameters display.
6. Drag and drop the necessary parameters into the variables table. In the example above, the @HideForms and @HideFormInVisits parameter sets have been added to the table.
7. Click the
Edit
icon of the applicable variable(s) and enter the Depth (for loops
or layers) that will generate the edit check.
In this example, an edit check is generated for each visit and for each form in the form set.
When you update the depths, those values display as part of the variables table. While it is unlikely to need a depth of more than 2 or 3, up to 6 layers of depth are permitted.
8. In the Edit Variable dialog, update the references to use the template parameters instead of a fixed variable path. Then click the Save button.
In the example above, as the generation loops through the visits and forms in the parameter lists, it replaces the path in the path/value with the current visit and form values (as shown below).
When you update the paths, the template displays as part of the path/value of the variable.
9. Click the Generate button at the bottom of the Template Edit page. This triggers the “looping through” of the template parameters and generation of the edit checks from these parameters. (You can view the generated edits by switching to the Generated Edits tab on the left.)
Clicking
a specific edit displays the details of the paths associated with that
edit. The edit check cannot be modified. The “Is Generated” check box
displays that the edit check is part of a template-generated set. Clicking
the icon
to the right takes you to the template edit where the edit check originated.
Note:
If you modify a template parameter by
adding items after generating the edit checks, the Generation Status of
the edit check changes to Failed.
If you open this edit check, the Failed button displays at the bottom
of the Template Edits page. This failed status means that the system cannot
generate the full set of edit checks with the parameters specified (e.g.,
a specified form does not exist in a specified visit).
The Skip invalid paths check box allows the set of checks to be generated, and skip over any paths (permutations) that do not exist. Click the Failed button to regenerate the edit checks if the generation has previously failed.
Note:
The Edit Check Warnings
Report analyzes the study build and indicates that if something that
might create problems (false positives are possible).The code is not analyzed,
rather the Target Path and Edit Check type as follows:
· Multiple DVx on the same path
· Hidden and Disabled Hidden edit checks on the same path
· Property edits with more than one instance per type and same path
· DVx circularity