Subject Data Extract includes incorrect data for different study versions and modes

The Subject Data Extract, when generated in Production mode, now contains entries only for the questions associated with an approved study version. This includes the study version in the Approved container, as well as any study version in the Archived container that was previously in the Approved container. Previously, this extract included questions added in a subsequent testing version as DeletedQn entries.

In addition, hidden questions are now included as expected, considering user permissions and data classifications.

(Issue 36730673)

User Assignment and User Assignement by Site reports fail to generate or have slow performance

The processing for the User Assignment reports has been optimized and safety checks for null values have been implemented so that the User Assignment and User Assignment by Site reports now generate successfully, for both current and historical data. This fix reduces processing time and effort, allowing these reports to generate in an acceptable time frame, according to the amount of data being returned.

Previously, these reports were failing for some studies due to a backward compatibility issue with particular data setup and conditions. This was observed in complex studies with high data volumes and when different filter configurations were applied.

(Issue 36440930)

Sites and Depots report with historical data fails to generate for large amounts of data and makes the system unresponsive

The Sites and Depots report now generates successfully, for all file types and regardless of data volume. Previously, the Sites and Depots report failed to generate for large amounts of data when historical data was included, causing the reporting system to become unresponsive. This was particularly observed when the report was generated in PDF format.

(Issue 36824952)

Subject Queries report with audit trail data fails to generate

The processing needed to generate the Subject Queries report has been optimized to reduce processing time and effort. Now, the Subject Queries report generates successfully, for all file types and regardless of data volume.

Previously, generating the subject queries report would time out and fail when processing large volumes of data. This would typically happen when filters were set to Include Audit Trail, All locations, and particularly observed when the report was generated in CSV format.

(Issue 36779220)

Blinded Kit Chain of Custody report groups kit numbers by kit type which is potentially unblinding

The kit numbers in the Blinded Kit Chain of Custody report are now in complete ascending order, irrespective of kit type, and regardless of applied filters.

Previously, when you filtered a Blinded Kit Chain of Custody report by a single shipment, kit numbers were listed in ascending order but grouped by kit types. This exposed partially unblinding information by revealing the kit numbers for the kits that belong to a same kit type.

(Issue 37106112)

The Study Role report does not show permissions data

The Study Role report now includes the permissions assigned to a study role. Previously, the permissions column would populate with N/A.

(Issue 36784681)

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.

(Issue 36741692)

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

(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.

(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

(Issue 36367831)