Reports, archives, extracts, and notifications

Questions with measurement units were not integrated as expected with Oracle DMW

Data managers and statisticians: When a question with numbers contains an associated measurement unit, that type of question is now displayed as NUMBER in the Type column, in the data extracts generated for the integration with Oracle DMW. Previously, a question with measurement units was displayed as VARCHAR2 (data that is varying) in the Type column. (Issue 34917672)

Questions with code lists were not properly displayed in the Subject Data Extract

Data managers and statisticians: Now, in a Subject Data Extract, the following types of questions are displayed as expected:

Questions with a code list applied to them where the code list's name contains special characters such as a forward slash (/).
Questions with a code list applied to them where the code value is not defined.
Questions with a code list applied to them where the code list was renamed prior to the 22.3 release.

Previously, these types of questions were not properly displayed in the Subject Data Extract. Moreover, there were times when generating this extract failed due to several validation issues. (Issue 34939373)

The User Assignment report is not populating a user’s username (former known issue)

User managers: Now, when you generate a User Assignment report with historical data, all usernames are displayed in the report, aspected. Whether a user is removed from a study, retired, active, newly created, or their account has been deactivated in Oracle Life Sciences IAMS, their username is properly displayed in the report. Previously, some usernames were displayed as "N/A". This happened when a user was deleted from the study and deactivated in Oracle Life Sciences IAMS.

Retracted workaround: Although this issue has been fixed, we still recommend you do not delete a user from a study. Instead, when required, set a specific End Date for their access to the study. That way, after the specified date, they will no longer be a part of your study and you can also maintain a record of their study association. (Issue 34483826)

Date range issues in the Kit Chain of Custody (Blinded) report (former known issue)

Sponsor users: Now, the Kit Chain of Custody (Blinded) report displays the kit transitions that have occurred on a certain date in the system, as expected. For example, if you choose 27-June-2022 as one of the dates in the Transaction Date setting, you may notice that kit transactions from that date are displayed in the report. Previously, kit transactions for specific dates were not properly displayed in this report. This issue was caused by a time zone inconsistency occurring in your browser.

Retracted workaround: None. (Issue 34300162)

A subject's status is displayed in English in a Japanese Kit Dispensation report

Site users: Now, when you generate the Kit Dispensation report, you will notice that a subject's status is displayed in Japanese, as expected. Previously, when your language preference was set to Japanese, you may have noticed that a subject's status was still displayed in English, despite the report having been generated in Japanese.

Note:

A subject's status is located in the header bar of the Kit Dispensation report.

(Issue 33087630)

Shipment creation notifications are not sent to depots (former known issue)

Clinical supply managers and depot users: Now, if you’re working in multiple studies at your organization, you may notice that depot facilities are receiving email notifications when a new shipment is created, as expected. Previously, the email associated with a customer depot did not receive shipment creation notifications when a new shipment was created.

Retracted workaround: None. (Issue 34307434)

Sequence numbers in the Submission PDF are not properly sorted

Sponsor and site users: Now, sequence numbers for repeating forms are sorted in numeric order only (for example: 1, 2, 3, 4, 5). Previously, sequence numbers were sorted in an alphanumeric order. For example, if a repeating form contained 10 instances, the 10th instance would be placed after the first and you would see 1, 10, 2, 3, 4. (Issue 34343692)

The Subject Queries report does not properly display query-related data (former known issue)

Sponsor and site users: Now, when you transfer a subject at another site and you modify an existing query at the previous site, the query update is properly displayed in the Subject Queries report. Previously, when you transferred a subject at another site and then you updated an existing query associated with that subject and their initial site, this update was not displayed in the report. For example, you updated an existing query at site A (their initial site) and then you added a new query at site B (the site where they were transferred). In the Subject Queries report, on the Last Updated On Site column, you may have noticed that the initial site was displayed, instead of the site where the subject was transferred to.

Retracted workaround: None. (Issue 34271619)

Lab ID and lab name only displayed for predefined lab rows (former known issue)

Note:

Lab IDs and names will only be displayed for labs going forward. IDs and names of existing labs in your study will not be displayed in the extract.

Study designers: Now, for a lab form, when you switch the Add Additional Rows toggle on, several users will get to experience the appropriate impact in the User Interface (UI).

Data managers and statisticians can now see all additional repeating rows in the Subject Data Extract. Columns in the extract are populated with data whether the additional rows are manually added by a site user (in the UI) or automatically through an integration.
Data managers and statisticians can only see the lab name and ID associated with these additional rows. Lab normal values are not displayed in the Subject Data Extract or the UI for additional repeating rows.

Retracted workaround: None. (Issue 32079296)

Inconsistent month format between blank and subject PDF (former known issue)

Sponsor users: Now, the month value in the Blank Form PDF file matches the month value in the subject PDF file. Previously, the month drop-down in the blank PDF file displayed Japanese characters which did not match the subject PDF output.

Retracted workaround: None. (Issue 32699964)

Site Confirmation and Download Log incorrectly displays data when administrative data contains commas

Sponsor users: Now, if administrative data such as a site's name includes a comma, the CSV output for the Site Confirmation & Download Log archive reports display administrative data in the correct cells. Previously, if a comma existed in a site's name (for example 'Health Center, ABC') the 'ABC' portion was inserted in the next cell. (Issue 33139699)

The Subject Data Extract does not display all code list values (former known issue)

Study designers, code list managers, and statisticians:The Subject Data Extract report now displays the code values in the expected format. Previously, we reported that for new and existing questions in a study, when you assigned a system default code list group to a study or a custom code list to a question, certain code values were not displayed properly in the Subject Data Extract. As an example, when you flagged a question with the "Not Applicable" option, the code value was not displayed in the Subject Data Extract.

Retracted workaround: None (Issue 34769175)