Reports, archives, extracts, and notifications

Record of removed and hidden dynamic forms appear in the Subject Data Extract

Now, any record of hidden dynamic forms that were removed does not appear in the Subject Data Extract when it is generated in any format. Previously, a record of dynamic forms that were removed and hidden with no form data showed in the Subject Data Extract.

(Issue 36528076)

Oracle CRF Submit archive requests fail with no saved data and open queries (former Known Issue)

Now, a Submission PDF, Archival PDF (site and sponsor), and Custom PDF request generate properly. Previously, the requests would fail to generate if a request included a subject with no data, but an open query, saved in any form at any visit.

Retracted recommended action: Use the FailureReport.txt, included with a failed request, to identify the subjects, then lock or freeze them. After a subject is Locked or Frozen, a subject PDF is generated successfully.

(Issue 36275528)

The Subject Events report displays a different label for kit numbers

Now, the Replaced Kit ID column is renamed to Replaced Kit Number in order to match the data displayed in the Subject Events report for that specific column.

For more information, see the Subject Events Report in the Reporting Guide.

(Issue 35864763)

Duplicate randomization events displayed in the Subject Events report

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 the system randomized a subject multiple times.

(Issue 33545211)

The Reason audit column in Archives PDFs is blank for transferred subjects

Now, when you select Other as the reason for transfer, the manually entered reason is displayed under the Reason audit column in the Subject Record Transfer History (prth.pdf) file, included with the subject PDFs for transferred subjects. For more information about Archives, see About archives and reports.

(Issue 36113596)

The User Assignment report contains incorrect organization data

The Organizations column in the User Assignment report correctly displays the organizations (sites and depots) assigned to a user instead of displaying N/A.

Previously, N/A was displayed when the system encountered an unexpected time-out before retrieving all data.

(Issue 35764367)

Oracle CRF Submit email notifications are not always received (former Known Issue)

Oracle Clinical One Platform now sends Oracle CRF Submit email notifications to all eligible users.

Note:

Eligible users are defined under each notification and include the following options: Sponsor Users, Site Users, and Default Email.

Previously, some users were not receiving email notifications due to a system limitation on the number of eligible users.

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

(Issues 35981904, related to the Storage limit has exceeded notification, and 36391622, related to notifications for the Sponsor and Site and the success and failure of requests, were addressed.

In the Rules report, the Visit Name column has a leading space

When generating the Rules report in CSV format, the Visit Name column header no longer contains a leading space.

Retracted recommended action: Manually remove the space in the output file.

(Issue 36710994)

The Kit Reconciliation report fails when site names include quotation marks

The Kit Reconciliation report now generates successfully even when site names include quotation marks.

Retracted recommended action: Remove the quotation marks from the site name, then re-run the report.

(Issue 36312970)

Oracle CRF Submit Archives Custom PDF requests fail when a misallocated kit is not associated with a visit

The Oracle CRF Submit Archives Custom PDF now generates successfully even if a visit is not selected when updating a kit's status to misallocated for a kit dispensed in error.

Note:

If you do not select a visit, the Subject History section of the PDF includes details about the misallocated kit.

For more information about RTSM data in archives, see the Submission PDF, Archival PDF (sponsor), Archival PDF (site), and Custom PDF requests.

(Issue 36308776)