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.
Warning Notification for PDF Merge Does Not Contain Full List of Documents
SAF-3237
When you merge a PDF from a binder containing a high number of documents, if any documents do not have a viewable rendition, the vault warning notification and email are truncated after a certain limit (approximately 35 documents) and do not contain the full list of documents.
Transmission Record(s) Generated for Cases with Product or Study Registration Outside of Reporting Obligation
SAF-2905
For Reporting Families set up to use the FDA reporting ruleset, the system still generates Transmission record(s) when a Case Product or Study Registration is set to a non-USA country.
Follow-Up Case Translation Document Language Changed to English
SAF-2372
When you create a Follow-Up Case, the Language (ISO) field on the Follow-Up Case translation document may be updated to English. This issue occurs when the Language (ISO) field on the initial case narrative translation document is blank, due to an E2B import with an invalid language code.
Unclear Error Message When an External Case Product is Ranked 1
SAF-2233
If you try to assign an External-type Case Product a rank of 1, an unclear error message similar to the following appears:
Primary Field: Field [external__v] is not valid for Object Type [{1}].
If you see this error message, note that the rank of 1 is reserved for primary Case Products. External Case Products cannot be assigned the primary role.
Case Expectedness Not Recalculated Once Case Product Indication is Updated
SAF-1996
When adding or updating a Case Product Indication, Vault Safety does not recalculate the Case expectedness.
This issue affects environments where a suspect Product Datasheet lists the reported adverse event as expected, qualified by the same medical condition reported on the Case Product Indication. In this scenario, the system determines that the adverse event is unexpected instead of expected.
Limitations
Consider the following product limitations when you use Vault Safety 19R3.
Invalid E2B Generated When Non-Parental Case is Selected as Parental Case
SAF-3341
In the Parental Case field, if you link to a case with the object type as Case (case__v) instead of Parental Case (parental_case__v), you will not be able to generate a valid E2B file.
If you generate an E2B file, the file will contain multiple primary records, such as Case Product, Case Adverse Event, and Case Reporter.
Case Counted in Both 15 and Non-15 Day PADER Tables
SAF-2498
If a Case meets the following conditions, it is included in both 15-day and Non-15 day alert PADER tables:
- The Case criteria is set to Serious and Unexpected.
- The Case Assessment Result > Result field is to No Reasonable Possibility.
Expected Adverse Events on Datasheet Not Protected by User Access Control
SAF-1987
Vault Safety does not currently support user access control for Expected Adverse Event records configured on a Product Datasheet. Any user can view the Expected Adverse Event records for any organization in their vault.
Blind Protection Not Supported for Datasheet Expected Adverse Events
SAF-1987
Vault Safety does not currently support blind protection for the Expected field on Case Assessments.
