Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
Note An asterisk (*) next to the issue number denotes an internally found defect filed during the development of Limited Release features.
Intake
Description
Issue Number
Test result and unit not imported when the unit does not match Vault Safety's UCUM library.
SAF-2276*
Vault Safety enables user access to Case creation according to the access configured on the Case Version object instead of the Case object type.
SAF-1792
Case Processing
Description
Issue Number
If either the Origin or Destination IDs on an E2B file are changed to no longer match the corresponding Transmission Profile, importing the E2B file with the Receive E2B API causes an error.
SAF-2330*
When a Case Adverse Event is linked to multiple Case Products, and the Case Products are configured in different Aggregate Reporting Families, the Case is likely to be counted multiple times in generated PADER tables.
SAF-2312*
When the Unblinding workflow starts on a Case, non-study Products transition to the Unblinding state.
SAF-2232*
During Case promotion for an Adverse Event Report linked to a Study, an invalid data error appears if the Organization name is over 60 characters.
SAF-1794
When an Imported Case does not contain a Case Number, a Null Pointer Exception message appears if you try to create a Follow-Up Case.
SAF-1680
When you create a copy of a unique Adverse Event Report, promoting the copied version to a Case might not show any potential matches.
SAF-1572
During an E2B import, if the file contains study details but the report type is not set to study, the system imports the file with a success notification instead of a warning message.
SAF-1868*
When you upload a document to the Library, and then classify the document Type as Datasheet, a server error appears.
SAF-2002*
When the Expected (status) field on the Case is set to Overridden, if the system automatically recalculates the Expected value on the Case Adverse Event, the Case Expected (status) field is not updated to reflect the auto calculation.
SAF-2006*
When you promote an Adverse Event Report to a Follow-Up Case, the resulting Follow-Up Case contains duplicate primary Adverse Event, Product, Case Reporter child records.
SAF-2180*
When you generate an FDA 3500A report from a Follow-Up Case, the system populates the Follow-up# field as 2 instead of 1.
SAF-2219
Reasons omitted fields are not hidden after entering a value.
SAF-1347
Safety Data Exchange
Description
Issue Number
Aggregate reports fail to generate if an empty template is provided.
SAF-2410*
Acknowledgments are not generated for manual E2B imports.
SAF-2339*
During an E2B(R2) file generation, narrative text is not generated if the case narrative contains more than 20 thousand characters.
SAF-2298
During an E2B import, if the Product Indication has a value of "Null," the system imports a value of "Null(MedDRA Version)" to the Product Indication>Name(Reported) field.
SAF-2144
If the study details in an E2B file do not a study in your vault, but the product registration details PhPID matches a product, the system maps the product as an external product during E2B import.
SAF-2028*
When you generate a CIOMS I form on a Case with a patient age of 0, the system populates the CIOMS I Age field with 0E0.
SAF-1908*
During an FDA 3500A report generation, the Product Registration number is truncated in section G.5
SAF-1892
During an E2B(R2) import, if the B.4.k.5.5 Definition of the Interval section contains 811 (Cyclical), 812 (As Necessary), or 813 (Total), the system does not import the value to the Product Dosage > Frequency field in the resulting Case.
SAF-1859
On Transmission records, the Organization field defaults to a blank value instead of Vault Customer.
SAF-1829
During an E2B(R2) import, the system does not import test result units.
SAF-1743
During an E2B file export, plain text and literature attachments should be HTML encoded.
SAF-1599
During an E2B(R2) import the system imports only MedDRA Lower-Level Terms (LLT).
SAF-1226
During an E2B(R3) export, if the Date field on a Case Test Result is set to Reasons Omitted > Masked, the system does not populate the F.r.2.1: Test Name section in the resulting E2B file.
SAF-467
During an E2B(R3) import, if the E2B file contains assessments with wrong or missing references and assessment results with wrong or missing references, the system only creates a single Case Assessment.
