Reports, archives, extracts, and notifications

OIDs are not unique in the ODM-XML metadata API (former known issue)

API developers: Now, the API response for the ODM-XML metadata no longer indicates that there are several validation errors for duplicate metadata values. Because different design elements in a study had the same reference code, their OIDs did not show up as unique in the ODM-XML metadata and clinical data extracts. Now, OID attributes contain unique GUIDs that will ensure the API no longer marks them as duplicates.

This fixed issue also ensures that there is no impact on a code list's OID, since code lists usually have the same reference codes and they showed up as duplicate in a clinical data extract.

Retracted workaround: None. (Issue 34702467)

Notifications are not properly filtered (former known issue)

Site and sponsor users: You can now successfully filter any notifications related to randomization, dispensation, or shipments by study mode and site. Previously, the site filter was not working.

Retracted workaround: None. (Issue 33729560)

The Kit Chain of Custody report displays incorrect data (former known issue)

Clinical supply managers and other sponsor users: Now, in the Kit Chain of Custody report, in the column Returned, Missing, Balance Units, data points for a shipment pending destruction and containing available kits are displayed as follows:
  • Missing units are displayed as "0".
  • Balanced units are displayed as "0".

Previously, instead of displaying “1 -0 -0” for when a shipment contained missing units or balanced units, the column displayed “1 - -“.

Retracted workaround: None. This is a display issue only. (Issue 33689816)

Site users with valid permissions could not view or download an Archival PDF (former known issue)

User administrators: Now, creating a role that includes the permissions, Download Archival PDFs and Audit Reports, and Confirm Download of archival PDFs and content allows site users to view, download, and confirm PDFs generated and shared by the sponsor without the need to add the permission, Run Archival PDFs for your sites to the role, which would allow site users also to generate PDFs.

Previously, if a site user was assigned to a role including both permissions, the user could not view or download the PDFs unless the Run Archival PDFs for your sites permission was added to the role.

Retracted workaround: Work with your user administrator to get temporarily assigned to the Run Archival PDFs for your site(s) permission. After downloading the archives, make sure your permission is revoked. (Issue 34655475)

Archive download failed if the request name included Chinese characters

Sponsor users: Now, the Download link does not appear if a request fails to generate successfully. Previously, the link would appear even if a request did not generate successfully. In cases like this, download attempts failed. This was due to Chinese characters being included in the request name.

Retracted workaround: None (Issue 34719206)

Chinese localization: File Type is not translated in the Download Log report

Sponsor users: Now, the File Type values: Archival PDF, Submission PDF, and Custom PDF, included in the report output, are translated correctly. Previously, the values under the File Type column appeared in English.

Retracted workaround: None (Issue: 34770064)

Chinese localization: No Records Found is not translated in the Site Confirmation report

Sponsor users: Now, when the Site Confirmation report is run and no records are found, the value No Records Found is translated correctly. Previously, the value appeared in English.

Retracted workaround: None (Issue: 34770019)