Review CRF version test case results

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.

Once the test cases are generated, the system automatically populates the respective case report forms (CRFs) with test data to execute the established rules. Once done, user interaction is required to verify if the CRF logic is working correctly.

Thus, you can review the summary of the CRF version test cases and assess the results—if the version is ready to be used in a study, or if the fixes must be applied to the CRF rules design in Study Designer (SD).

Important

The test case results are generated for incremental data—only differences between the CRF version being tested and the currently effective CRF version on PROD.

To review the CRF version test case results

In the EDC application header, select the STUDY INFO tab.
On the page that opens, in the left pane, select CRF Version > Edit Check Testing Case.

Figure 1. Accessing edit check testing
On the Testing Case Version page that opens, locate the test case version for which you want to review results. Then from the Action column, select Info .

Figure 2. Accessing CRF version test case results

On the Testing Case List page that opens, review the test case result details as explained in the following table.

Figure 3. Reviewing CRF version test case results

Tip

Use the Filter case dropdown menu on the workspace toolbar to organize your table records as follows:

All: select this option to review all the generated test case records.
Matched: select this option to review only the test case records for which the EDC system can execute the established rule.
Unmatched: select this option to review only the test case records for which the EDC system cannot execute the established rule.

Column

Details

Check #

Represents the sequential number of edit check test cases that have been run. There are always two cases with the same number in the table because the system runs both positive and negative result testing for each edit check.

Case Type

Represents one of the following:

Positive: the test is performed to verify that a given scenario or rule will be executed with a satisfactory result.
Negative: the test is performed to check whether the reverse scenario will be executed with a satisfactory result.

For instance, there is a rule that only for female subjects the question "Of childbearing potential?" appears in the CRF, and for male subjects, this field is missing.

A positive case type is when the system checks if in the "Sex" field the answer is "Female," then the field "Of childbearing potential?" appears automatically.

A negative check is when the system checks if in the "Sex" field the answer is "Male," then the field "Of childbearing potential?" does not appear.

Visit Name

Represents the name of the visit to which the CRF belongs for whose logic verification the test case is run.

Form Name

Represents the name of the CRF, for whose logic verification the test case is run.

Variable Name

Represents the name of the variable for whose logic verification the test case is run.

Item Name (Data Point)

Represents the text of the CRF question, for whose logic verification the test case is run.

Sub - Item Name (Sub - Data Point)

Represents the subsequent to the main question of the CRF, for whose logic verification the test case is run.

For instance, if the question (item) is "Weight" with the answer in an integer value, then the subitem can be the unit to define how the weight is measured—kilograms, pounds, and so on.

Logic

Represents the rule defined in SD to outline the logic of the CRF behavior.

For instance, a rule is that only for female subjects the question "Of childbearing potential?" appears in the CRF, and for male subjects, this field is missing. The logic for this rule can be established like: "Only if "Sex / Female" is selected, then "Of childbearing potential" is enabled."

If the logic requires amendments, select Edit next to the test case and in the resulting dialog, update the logic text and provide optional comments if needed. The comment provided here is displayed in the Comment column of the table.

Figure 4. Updating test case logic

Comment

Represents a comment added by the user upon marking the test case as passed or failed or when updating the test case logic.

Expression

Represents the expression designed in SD to execute the logic of the CRF item according to the established rule.

Query Text

Represents the text of the query that is to be triggered by the system according to the field completion logic.

For instance, if the field is mandatory for completion and the user attempts to submit it empty, the system triggers a query "Data required." The "Data required" query text you can see in this column.

Type class

Represents the type of rule that must be executed for the CRF or its item, such as:

This rule is designed for the EDC system to automatically populate some data into the CRF field based on the established logic.

For instance, if the autofill of the test result interpretation is configured for the lab data CRF, once the lab results are entered into such forms, the system autopopulates the field "Outcome" with "Normal" or "Abnormal" based on the preconfigured judgment.

This rule is designed for the EDC system to automatically trigger follow-up CRFs based on the answers provided in the original ones.

For instance, if the "Chemistry details available" field is stated as "Yes," then the "Chemistry details" form appears.

This rule is designed for the EDC system to check if the data entered for the same subject in various CRFs is consistent.

For instance, if the subject's serious adverse event (SAE) resulted in death, the date of death in the SAE form cannot be earlier than the birth date in the demographics form.

This rule is designed for the EDC system to automatically trigger CRF items depending on the answers provided in the previous ones.

For instance, if the "Sex" field is answered as "Female", then the question "Of childbearing potential?" appears. If in the "Sex" field the answer is "FMale", then the question "Of childbearing potential?" does not appear.

This feature is under development and will soon become available in the eClinical system.

This rule is designed for the EDC system to check if the value entered in the CRF field is within or out of the preconfigured range.

For instance, for the chemistry details of the subject, the system checks if the entered lab result is within the established normal ranges.

This rule is designed for the EDC system to check if the data is entered into mandatory fields and prevent users from submitting forms with missing data.

This rule is designed for the EDC system to check if the entered data satisfies the preconditions.

For instance, the date and time validation ensures that the dates are accurate.

This rule is designed for the EDC system to check if the data entered in the same CRF is consistent.

For instance, if there are fields "Start date" and "End Date," the system checks that the end date is not earlier than the start date.

Condition

Represents one of the following:

New: the rule execution is tested for the first data entry to the CRF or its item.
Updated: the rule execution is tested for the data amendment in the CRF or its item.

For instance, when the date of SAE occurrence is first entered (new), no specific rule is applied to the CRF field. However, if the date is updated, the field "Date change reason" is triggered and becomes mandatory.

Test Subject

Represents the unique identification number of the subject for whose CRF the logic verification test case is run.

Test Value

Represents the value that is selected as an answer to a question to trigger the rule execution.

For instance, the expression is: " Screening / Demographics / Sex / Femail" is selected.

In this example, the system tested what happens if for the "Screening" visit, in the "Demographics" form, the answer to the question "Sex" is "Female". So here, "Female" is the tested value.

Another example of a tested value can be "BLANK". Then, the system tested what happens if the answer to the question is not given—the field remains blank.

Query Fired

Represents one of the following:

Enabled: the failure to execute the established logic triggers the system query.
Disabled: the failure to execute the established logic does not trigger the system query.

P / F

Represents the user-selected value as follows:

The value stands for "passed" and states that the user has checked and validated the satisfactory outcome of the performed test case.

For instance, the test is passed if the logic is working: "Sex" = "Female", and the question "Of childbearing potential?" appears; for "Sex" = "Male", the question "Of childbearing potential?" does not appear.

The value stands for "failed" and states that the user has checked the outcome of the performed test case and it was unsatisfactory.

For instance, the test fails if the value "Sex" = "Male" and the question "Of childbearing potential?" still appears.

Tested By

Represents the name of the user who performed the review of the CRF version test case results.

Tested Date

Represents the date when the review of the CRF version test case results was performed.

Once the details are viewed, confirm the test case in one of the following ways:
- To review the individual test case within the related CRF, from the Action column next to that test case, select Go to CRF . On the form page that opens, see how the established logic is executed. Then in the Test Case Checklist table, select Confirm .
  
  For instance, you want to check the logic that the "Image Details" form only appears if the "Details Radio Field" field is selected as "Yes". Then, you go to the CRF page, answer the respective question as "Yes", and see if the rule is executed correctly. Based on the outcome, you can confirm whether your test case passed or failed.
  
  Figure 5. Testing case confirmation in CRF
  
  Tip
  
  You can use the Test Case Checklist table to navigate between test cases without returning to the Test Case List page. However, you can select Back to Test Case List to return to the comprehensive test case result table.
- To review individual or multiple test cases from the Testing Case List table directly, select the checkboxes next to the test case results that you want to review. Then from the workspace toolbar, select Confirm .
  
  Figure 6. Accessing CRF version test case result confirmation

In the dialog that opens, confirm the test as passed or failed as explained in the following table.

Figure 7. Marking test as passed

Element	Details
Pass	Select this option if the test result is successful and the CRF behavior rule is executed as expected.
Fail	Select this option if the test result is unsuccessful and the CRF behavior rule is not executed as expected.
Comment	Enter any auxiliary details you find useful to support your judgment.
SAVE	Select to implement the changes.
CANCEL	Select to discard the changes without saving and return to the testing case list.

Once saved, the CRF version test case results are reviewed and confirmed as passed or failed.

In this section:

Review CRF version test case results

Important

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