Reports, archives, extracts, and notifications

Renaming a study using special characters does not work in Oracle CRF Submit (former known issue)

Sponsor users: Now, when the study rename command is run on the Oracle CRF Submit shared server the command is executed as expected. Previously, if you performed this update and then the command was run, a 404 not found error was displayed.

Retracted workaround: In Oracle Clinical One Platform, you no longer have to avoid using special characters when renaming your study. (Issue 33001503)

Oracle CRF Submit archive requests do not appear to be removed (former known issue)

Sponsor and site users: Now, when you attempt to delete an archive request from the Download Archives section, the request is removed, as expected. Previously, when you attempted to delete an archive request you may have noticed that the request was not removed from the User Interface (UI).

Retracted workaround: You no longer have to refresh the browser page or collapse and expand the Download Archives pane to reflect the removal of the archive requests. (Issue 33306063)

Kit Chain of Custody (Unblinded) report does not properly display a subject’s number (former known issue)

Clinical supply managers and statisticians: Now, in the Kit Chain of Custody (Unblinded) report, the Subject Number column is no longer populated with a subject’s number for a kit that has a status of Available. The subject number is still displayed for a kit that has a status of Not Dispensed to Subject for troubleshooting purposes. Previously, a subject number was always displayed in the Subject Number column, even for kits that should not have that number associated with them, such as kits that were previously in a state of Not Dispensed to Subject and then updated to Available.

Retracted workaround: None. (Issue 33406968)

Oracle CRF Submit archive requests do not appear to be removed (former known issue)

Sponsor and site users: Now, when you attempt to delete an archive request from the Download Archives section, the request is removed, as expected. Previously, there were instances when you could not remove an archive request from the UI.

Retracted workaround: You no longer have to refresh the browser page or collapse and expand the Download Archives pane to reflect the removal of the archive requests. (Issue 33306063)

Date validation rule not displayed as expected in reports (former known issue)

Sponsor users: Now, when you run the Study Design report or the Annotated Case Forms report, date validation rules are properly displayed. Specifically, when a date field in a form allows for a partial date (with a validation rule applied to it such as On or After), the reports show the date the field was added by the study designer. Previously, these reports displayed the date the field was last edited.

Retracted workaround: None. (Issue: 33421485)

Duplicate lab names displayed in Subject PDF (former known issue)

Sponsor users: Now, when generating an Archival PDF, in the Subject PDF, you will notice that there are no duplicate lab name fields in the lab form. Previously, you could identify duplicate lab name fields in the lab form, whether the lab name was populated or not.

Retracted workaround: None. (Issue 33047606)

Calculated values do not work in the table of a two-section form (former known issue)

Rule designers and testers: Now, when the target field of a calculated value is included in a two-section form (in the repeating form table), the custom rule is running as expected and the target field is populated. Previously, a calculated value did not work and the target field included in a two-section form was not populated at all.

Retracted workaround: You no longer need to refresh the browser's page to display the calculated value. (Issue 33135305)

Saving drop-down value is not working during subject visits for question groups in two section forms (former known issue)

Study designers: Now, when you create a two-section form with question groups, and drop-down questions within the question group, a site user can save those drop-down values, as expected. Previously, a site user could not save the data that they selected for a drop-down question included in a question group.

Retracted workaround: None. (Issue 33306238)

Duplicate randomization events displayed in the Subject Events report (former known issue)

Sponsor users: Now, in the Subject Events report, the randomization event is displayed a single time for every subject. Previously, the randomization event was displayed multiple times for the same subject, making you think that the system randomized a subject multiple times.

Retracted workaround: None. (Issue 33545211)

Missing statuses in the Subject Events report (former known issue)

Sponsor users: In the Subject Events report, you now see all of the expected visit statuses regardless of how you combine the filters for this report. Previously, you may have noticed that the Event Type column was missing several visit statuses. The report only displayed three common statuses: Visit Complete, Visit Date Changed, and Visit Started.

Retracted workaround: None. (Issue 33555141)

The Subject Visits report does not work without a Subject status filter (former known issue)

Sponsor and site users: Now, you can generate the Subject Visits report (blinded or unblinded) without specifying an option for the Subject Status filter. Previously, without the filtering option, you could not generate a Subject Visits report. Clicking the Run Report button did not start the generation of the report.

Retracted workaround: Make sure you always specify details for the Subject Status filter. (Issue 33572955)

The Subject Queries report does not work (former known issue)

Sponsor users: Now, you can generate the Subject Queries report without encountering any issues. Previously, when attempting to generate the Subject Queries report, you may have noticed that the report could not be generated at all. Other times, it took too long for the report to be generated.

Retracted workaround: None. (Issue 33626740)

A SAS or CSV data extract does not display deleted data (former known issue)

Data managers and statisticians: Now, when you extract subject data in a SAS or CSV format, the extract specifies when a section from a two-section form is removed. Previously, this detailed was not displayed in the extract.

Retracted workaround: None. (Issue 33537242)