Reports, archives, extracts, and notifications
Study Design report displaying incorrect treatment group description after edit
Study designers: Now, the correct description appears in the Study Design report after editing the description. Previously, both the original and the updated descriptions were appearing in the report. This issue was encountered due to a missing study version constraint in the reporting query that is used to join the treatment arms. This resulted in the query picking up both the old and new descriptions in the report.
Retracted workaround: None. (Issue 34087670)
The Subject Visits (Unblinded) report does not predict drug needs properly (former known issue)
Site users: The Subject Visits (Unblinded) report now includes study drug prediction data for all applicable visits in the study. Previously, you may have noticed that there was no study drug prediction for certain visits in the study. Specifically, those visits that have the option for a site user to down titrate a subject to a lower dose. Based on the study’s design, you must be able to view the study drug prediction in this report.
This issue was specifically occurring when the first dispensed kit in a study was a kit type titration.
Retracted workaround: None. (Issue 33920237)
The Unblinded Kits Dataset returns duplicate records
Clinical Supply Managers: Now, the Unblinded Kits Dataset returns unique records only. Previously, records were being stored in two separate database tables and were considered unique. This resulted in duplicate records being inserted into the dataset.
Retracted workaround: None. (Issue 34062042)
Report-related emails are not sent to valid email addresses (former known issue)
Sponsor and site users: Now, when you include a list of email addresses in the scheduled reports configuration, all users receive the notifications. Previously, no one included in the email notification configuration received the email. This was caused by additional spaces in the email list resulting in both valid and invalid email addresses included in the configuration not receiving the completion notification.
Retracted workaround: You no longer have to specifically look for extra spaces between email addresses in the scheduled report configuration, although we still recommend that you make sure the email addresses you specify are correct. (Issue 34058969)
Blank PDFs do not match study design when forms are copied
Sponsor and site users: Now, when a Sponsor or site user generates an Archival PDF in Testing mode, for a study that includes copied forms, the blank PDFs included in the Archival package include the correct question labels. Previously, the blank PDF would display the label of the question copied from, and not the renamed, new question label.
Retracted workaround: None. (Issue 33985315)
Subject Data Extract report fails using SAS format when a decimal contains leading zeros
Sponsor users: Now, when generating a Subject Data Extract report that includes form items containing a decimal with leading zeros, you no longer receive an error indicating a report failure. Previously, when you attempted to generate a report, the report failed if an item contained a decimal with leading zeros (0.5 for example). This failure was caused by a newer version of the org.json library that incorrectly removed leading zeros from a decimal value.
Retracted workaround: None. (Issue 34109490)
Subject Data Extract report fails when using SAS format due to leading zeros
Sponsor users: Now, when generating a Subject Data Extract report that includes numeric form items containing data with leading zeros, you no longer receive an error indicating a report generation failure. Previously, when you attempted to generate a report, the report failed if a numeric form item included leading zeros (05, or 005, for example). This failure was caused by a newer version of the org.json library that did not correctly remove leading zeros from numeric form items.
Retracted workaround: None. (Issue 34087227)
Options in the Study Version dropdown are not all displayed for a Blank Form PDF (former known issue)
Sponsor users: For a Blank Form PDF request, when you attempt to configure the Select Versions filter, all available study versions are displayed in the dropdown list. The number of displayed study versions has now increased from 15 to 30. If more than 30 study versions exist for your study, a More results available, please filter further prompt is displayed.
Retracted workaround: None. (Issue 33531303)
Subject PDFs now display a note for subjects who once exited the study
- Superseded due to Withdrawal reversal
- Or Superseded due to Study Complete reversal (Issue 33861203)
Some notifications must be site-specific (former known issue)
Site users: From now on, you will only receive notifications for the sites that you are assigned to and for which you have the corresponding permissions. Previously, you may have received certain notifications that were not specific to the site that you were assigned to.
- Not Dispensed to Subject (Unblinded)
- Not Dispensed to Subject
- Not Dispensed to Subject (Unblinded Pharmacist)
Retracted workaround: None. (Issue 33775119)
Numeric data not properly displayed in the Subject Data Extract (former known issue)
Data managers and statisticians: Now, in the Subject Data Extract, all numeric data is displayed as expected. Previously, null numbers interfered with the way other numbers were displayed in the extract. This issue was observed for extracts generated in a sas7bdat. format only.
Retracted workaround: None. (Issue 33860587)
Data flags are not properly displayed in the ODM-XML extract (former known issue)
Sponsor users and API developers: Now, data flags that a user applies to a field in Oracle Clinical One Platform are displayed as expected in the ODM Clinical Data XML extract. Previously, data flags in the ODM-XML extract did not match the data flags in Oracle Clinical One Platform. This issue was caused by an API error that is now fixed.
Retracted workaround: None. (Issue 33722382)
Parent topic: Fixed issues