Forms, visits, and rules

Subject visit shows as incomplete or unsaved when a Show Form rule is applied

Site users: Now, the form saves the data and the visit is complete when a dynamically displayed form is present in that visit. Previously, the subject visit showed incomplete or unsaved data, even when the subject already completed the screening or did not select the question that dynamically displayed a form.

Note:

This issue occurred when the Show Form rule was modified and applied to a new study version, as an advanced study versioning change.

(Issue 34314729)

Frozen, dynamic questions, do not update when unfreeze action applied

Site users: Now, dynamically displayed questions unfreeze successfully allowing the site user to edit the question. The appropriate icon is also displayed. Previously, a dynamically displayed question was not successfully unfrozen limiting the user's ability to edit the question. The appropriate icon was also not displayed.

Retracted Workaround: None. (Issue 34287424)

A visit's status is not updated when a subject fails screening

Site users: Now, when a subject fails screening during a screening visit that contains both screening and randomization events, the status of that screening visit is marked as Complete with Errors, as expected. Previously, the screening visit's status was not updated and remained as In Progress. This caused several issues in the system, particularly with signing the data for a visit like this.

Inconsistent rule behavior for automated queries

Rule designers: When an automated query rule is configured for unscheduled or study completion visits, you may notice that queries are not displayed, as expected. This issue can be reproduced when the operand and target items are configured in the Questions Before the Table section of a two-section form. (Issue 34183025)

Duplicate emails might be sent out based on a custom rule (former known issue)

Rule designers: Now, when you create a rule to send an e-mail notification, if the email address of a user is specified twice as a testing email address or both as a Testing and Production email address, one single email is sent out to that specific email address. Previously, duplicate e-mail messages were sent out to that specific user.

Retracted workaround: Although the email is now sent only once for the same email address, you should still make sure that you only specify each email address once, when you create a custom rule for an email notification. (Issue 33987346)

Large code lists take longer time to save (former known issue)

Study designers: Now, when a code list contains over 200, you can save that code list without any interruptions or delays. Previously, with larger code lists, you may have noticed that the application was taking longer than usual to save any of your changes, such as applying it to a question in a form.

Retracted workaround: None. (Issue 33948251)

Long questions are not properly displayed in a notification email (former known issue)

Study designers and other sponsor users: Now, you can use longer question titles and they will be displayed appropriately in a notification email. Previously, when the questions included in a form were too long, the users receiving any notifications related to changes for those questions were not able to properly view the entire list of questions that generated a notification.

Retracted workaround: You no longer have to avoid using question titles that are longer than usual (typically over 200 characters). (Issue 33938985)

Skipped visit is marked as In Progress after being frozen (former known issue)

Data managers: Now, when you freeze data in a skipped visit and do not create a new study version that you assign to a site, that visit's status remains Skipped, as expected. Previously, when you froze data in a skipped visit, that visit’s status was updated to In Progress. This issue occurred when several settings and actions were previously performed:

• The settings Site Enters Visit Dates, Site Edits Visit Dates, and Visit Can Be Skipped were configured for a Dispensation, Option, and Non-Dispensation visits.
• A new study version was generated and moved to Testing or Production.

Retracted workaround: None. (Issue 34122179)

Clearing a custom rule error message leads to clearing a coding item target (former known issue)

Site users and rule designers: Now, after a custom rule's error message is no longer displayed on the screen, the associated coding target items aren't cleared, as expected. Previously, after a custom rule's error message was cleared from the User Interface (UI), the system also cleared any verbatim terms from the forms. This interfered with the way terms were coded in a form.

This issue was reproduced in an Adverse Event.

Retracted workaround: None. (Issue 34111603)

Cannot enter lab result in a lab form’s row (former known issue)

Site users: Now, in a lab form, when you open a row in a new dialog (to fill in fields), you can enter data straight into the lab form table. Previously, you may have noticed that you were no longer allowed to enter data straight into the lab form table. Instead, you could only fill in fields in the form by opening each row in a separate dialog.

Retracted workaround: You no longer have to return to the Subject page and then re-open the visit that contains your lab form. (Issue 33905908)

A designer must refresh the page to see a lock icon (former known issue)

Study designers: Now, when working along multiple study designers, you no longer need to constantly refresh your browser's page to make sure that the lock icon is displayed or not (depending on whether other designers are working in the study or not). Previously, you had to refresh your browser page when working with multiple study designers.

This was caused by a backend issue that determined the system to not display the appropriate lock icons after data was refreshed.

Retracted workaround: You no longer have to constantly refresh your browser's page to make sure that the lock icon is either displayed or not, or that newly created forms by other designers are displayed. (Issue 33665785)

Data flags in dynamic lab forms not displayed when user changes the parent question values (former known issue)

Study designers: Now, when testing forms in Testing mode, you will see that data flags are properly displayed in a dynamic lab form. Previously, after modifying the answer to a determining question, you may have noticed that the data flags that were previously applied in a lab form were no longer displayed.

Retracted workaround: None. (Issue 32723537)

Target field in two-section form is not updated (former known issue)

Rule designers and testers: Now, after you define a custom rule with a read-only target field located in a two-section form, you may notice that the target field is updated after that rule is run, as expected.

Retracted workaround: After the rule runs, you no longer have to refresh your browser’s page. The system automatically refreshes the data and the updated value appears in the target read-only field. (Issue 33047748)

The Rules Editor dialog title is now translated to Japanese

Rule designers: When the application's language preference is set to Japanese, you may notice that the Rule Editor dialog title is properly translated to Japanese. Previously, this title was not translated and was displayed in English. (Issue 32914076)

The Rules sidebar does not display data from the current form (former known issue)

Rule designers and testers: Now, when navigating between forms, the Rules sidebar displays data related to the form that you are currently accessing. Previously, the Rules sidebar displayed rules-related data from the previous form you just accessed.

Retracted workaround: None. (Issue 33635407)

Schedule Above First section is properly formatted in Japanese

Study designers: On the Data Collection page, the Schedule Above First section (displayed in-between unscheduled visits in a branch) is now properly displayed on the user interface. Previously, the words did not fit and looked misaligned. This issue only occurred when the application's language preference was set to Japanese. (Issue 32903499)

Advanced study versioning updates do not work during multiple study updates (former known issue)

Study designers: Now, when you perform an advanced study versioning update and then attempt to move the study version from Testing to Approved (in one type of browser) and then create a new study version (in another type of browser), an error message is displayed. The error message states that the creation of a new draft study version has failed, as expected. Previously, after performing these two simultaneous study updates, you may have noticed that your advanced study versioning updates were no longer reflected in the updated study version.

Retracted workaround: None. (Issue 33416734)

The lock icon disappears from a locked form (former known issue)

Study designers: Now, the lock icon continues to be displayed on a form while you (as a study designer) are deleting another form in the study. Previously, when you attempted to delete a form (for example, Form A) and another study designer was editing another form (for example, Form B), you may have noticed that the lock icon disappeared from Form B.

Retracted workaround: You no longer have to refresh your browser’s page to have the lock icon reappear. (Issue 34058105)