Generate test case for CRF version
The CRF configuration is complex due to many dependencies, special logic, and other rules configured for form behavior that satisfy sophisticated data collection processes in clinical trials. Thus, in Study Designer (SD), along with designing a CRF version, you configure specific rules that result in a list of edit checks that must be run for the CRF upon data entry to check if the stated logic and dependency for forms work correctly.
In EDC, you can generate and run testing cases for your configured CRF versions in the test—UAT—lifecycle before pushing the newest version and initiating actual data entry in the production—PROD—lifecycle. This helps you prepare the fault-free CRF version and avoid situations of broken logic only outing when the actual data entry starts.
Important
To generate a testing case successfully, ensure to meet the following preconditions:
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In the EDC application header, select the STUDY INFO tab.
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On the page that opens, in the left pane, select CRF Version > Edit Check Testing Case.
Figure 1. Accessing edit check testing
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On the Testing Case Version page that opens, from the workspace toolbar, select the site for which you want to generate the testing case. Then select New Item
.
Figure 2. Selecting site to generate testing case
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In the Add Case Version dialog that appears, complete the case version as explained in the following table.
Figure 3. Adding testing case version
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
Case Version*
Enter the testing case version number. Keeping track of versioning helps you differentiate between various test cases generated for the site and distinguish the ones that were more or less successful.
CRF Version
Represents the read-only unique identifier of the latest CRF version for which you generate the testing case to compare its efficiency to the currently effective CRF version in the production (PROD) environment.
Comparison of PROD CRF Version
Represents the read-only unique identifier of the currently effective CRF version in the production (PROD) environment to which the latest CRF version will be compared with this testing case.
SAVE
Select
to implement the changes.CANCEL
Select
to discard the changes without saving, close the dialog, and return to the Testing Case
Version page.
Once saved, the testing case is generated and run and you can now review the comparison results.