Reports, archives, extracts, and notifications

The Subject Data Extract fails to generate

The Subject Data Extract now generates successfully when generated by a blinded user, allowing blinded data to be extracted for review outside the system.

(Issue 37008259)

No line breaks in the Life Sciences Learn Training Report

The CSV version of the Life Sciences Learn Training Report now contains proper line breaks between each record, ensuring that you can properly view your learning data.

(Issue 36442280)

Some users might not be able to generate the Subject Visits (Unblinded) report

As long as you have the appropriate permission (Run the Unblinded Subject Visit Schedule Report), you can successfully generate the Subject Visits (Unblinded) report. Previously, running this report may have resulted in a failure due to an API issue.

(Issue 35528180)

Some reports won't generate successfully for certain custom sponsor study roles

Users assigned to a custom study role that includes either the View Sites or View Depots permission can now successfully generate reports. Previously, report generation would fail if the study role did not also include either the Create and Manage Sites or Create and Manage Depots permissions.

Retracted recommended action: Update the custom study role by adding Create and Manage Sites or Create and Manage Depots, depending on which reports you need to generate.

Impacted reports:

Subject Queries report
Subject Events report
Subject Visits (Blinded) report
Subject Enrollment report
Subject Data report
Kit Chain of Custody (Blinded)
Kit Inventory (Blinded) report
Randomization List (Blinded) report

(Issue 36741692)

Oracle CRF Submit Archives Settings, configured for Testing Mode, are incorrectly applied to Production Mode

The email notification settings initially defined under Testing Mode (on the Study Settings—Archives Settings tab) are no longer applied to Production Mode.

Note:

For more information about Archives Settings, see Email and in-application notifications.

(Issue 35987053)

Oracle CRF Submit Archives Blank Form PDF displays an incorrect question option

The Blank Form PDF displays the correct options associated with each question.

The issue occurred because two questions on different forms were designed with the same refname (SAS Label) value. This led to a conflict when Oracle CRF Submit pulled the questions into the archive, as it could not determine the correct options due to the duplicate question refnames. As a result, options associated with the other question were displayed.

(Issue 36395284)

Oracle CRF Submit Archives display the incorrect form status for the Date of Visit form

After clearing all data on forms in a dynamic visit and untriggering the dynamic visit, the correct form status, Not Started, displays instead of Completed in Oracle CRF Submit archives for the Date of Visit form.

(Issue 36393008)

The Oracle CRF Submit Kit Chain of Custody report Table of Contents is empty

When you generate the Kit Chain of Custody (Blinded) report on the Archives tab, the Table of Contents (TOC) includes the expected details instead of being blank.

(Issue 36380339)

Oracle CRF Submit Archives status shows Created when, in fact, they fail due to exceeding the storage server limit

When you generate any Oracle CRF Submit Archive, and the request exceeds the storage server limit, the system presents you with the failure message, Failed Out of storage.

Previously, the status in the Download Archives side panel incorrectly indicated it was generated successfully by displaying the status Created.

Note:

In a previous release, the storage server allocation per customer was increased from 100 GB to 1000 GB to minimize issues with storage server errors.

Retracted recommended action: Manually delete old archives to free up space on the storage server, then regenerate the failed request.

(Issue 36110325)

The Oracle CRF Submit Storage limit has exceeded notification is being sent every 30 Minutes

The Storage limit has exceeded notification, which is used to notify sponsor users when a request generated for a study exceeds the allocated storage server limit for a tenant, is no longer sent every 30 minutes when the email list exceeds 255 characters, and the notification status is successfully updated to Processed.

For more information about Oracle CRF Submit notifications, see Email and in-application notifications in the Reporting Guide.

(Issue 36744636)

The Kit Chain of Custody (Blinded) report contains empty rows

The Kit Chain of Custody (Blinded) report output file no longer contains additional empty rows when you select All under the Location filter. This occurred because some sites (Locations) included in the report had no kit-related data entered. The report now ignores these sites (Locations) when generating.

Note:

This issue concerns the Kit Chain of Custody (Blinded) report, available under the Archives tab after clicking Reports & Archives.

Retracted recommended action: Generate the report by selecting only those sites (Locations) with kit-related data.

(Issue 36367831)