Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
Known Issues
Consider the following known issues when you use Vault Safety 19R3.
Study Site Reporter Contact Details Not Checked During Duplicate Detection
SAF-6011
When a preconfigured Study Contact is selected in the Site Reporter field during AER intake, the system does not check the reporter fields (name, country, and so on) against other Cases during duplicate detection.
Dose Frequency Unit is Not Exported When Set to a Non-Standard Value
SAF-5566
During an FDA E2B (R2) export, the dose frequency unit is not exported if the Frequency field is set to cyclical, as necessary, or total. In addition, no notification is sent to the user who initiated the E2B export action.
Literature Attachments Not Classified as Literature During E2B Import if Literature Document Lifecycle is Changed
SAF-5537
If the document lifecycle on the Case > Source > Literature document type is changed from the Case Source Lifecycle, the system cannot extract literature attachments during an E2B import. Also, the system does not mention the failure to import the attachment in the E2B import notification.
The Literature document type must be assigned the Case Source Lifecycle for Vault Safety to import literature attachments properly from an E2B file.
Study Products with a Drug Role of Treatment Included in DSUR Tabulations
SAF-5093
DSUR aggregate report tabulations include Cases with the Study Product Drug Role field set to Treatment.
Event Onset Date and Seriousness Overwritten in Follow-Up Case
SAF-5381
When a Follow-Up Case is created, the adverse event Onset Date and Seriousness from the initial Case are overwritten in the Follow-Up Case version, even when the data is less accurate, such as being masked or specified to a less precise date.
Field Help Tooltips Do Not Appear on Section Controls
SAF-4753
Once the Case Product Dosages and Indications section controls are added to page layouts, help text does not appear when you hover over fields within these sections.
Test Results with Same Test Date are Sorted by Creation Date on CIOMS I
SAF-4590
While test results are sorted by date on generated CIOMS I forms, if multiple test occurred on the same date, the tests are sorted in order by the Test Result record creation date.
Confusing Field View After Entering 1 times per x in the Frequency Field
SAF-4260
In the dosage Frequency field, when you enter a value of 1 times per unit, once you save the page the field reads “Every 1 units”. For example, if you enter 1 times per day, the field reads “Every 1 days” instead of “1 times per day.” This issue does not affect data integrity or compliance.
Gateway Transmission Invalid File Error Notification is Not Visible to Distribution Manager
SAF-5381
When an invalid file type, such as a PDF, is sent as a Gateway Transmission, users in the Distribution Manager role are not notified about the transmission error. Instead, only users assigned the Vault Owner role receive the notification.
