Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
You may encounter the following known issues or limitations in certain environments or configurations. Where possible, workaround instructions are provided to solve the issue.
We actively investigate all known issues and will be providing fixes and updated information in future releases.
Business Administration
Cannot Edit Name of NMPA Report Source
SAF-28619
On the NMPA Report Source Controlled Vocabulary type, editing the Name field is prevented by the system.
Intake
Combination Product Registration Not Populated After Case Promotion
SAF-28665
After promoting a Case with a Combination Product that has Product Registrations, the Product Registrations are not populated.
Deep Duplicate Search Causing Performance Issues
SAF-26883, SAF-28182
When enabled, the Deep Duplicate Search feature causes a slower than expected performance during duplicate detection and Case promotion.
Errors When Promoting E2B Imported Inbox Items to Case
SAF-27792
For Inbox Items imported from an E2B file, the system calculates a negative normalized age and displays an error message in the following scenarios:
- Patient date of birth is later than the adverse event onset date
- Patient date of birth is later than the receipt date
- Adverse event onset date is later than the cessation date
When this occurs, the system prevents Case promotion.
Expanding and Then Collapsing the Case Contact Section of an Inbox Item Causes Blank Page
SAF-28465
For imported Inbox Items, expanding and then collapsing the Case Contact section causes a blank page to appear.
Workaround
Refresh the page. The Inbox Item appears as expected.
Follow-Up Case Cannot Be Created if Inbox Item Case Identifiers Include Leading or Trailing Spaces
SAF-31206
When an Inbox Item contains Case Identifiers with leading or trailing spaces (for example, “NN-ABCD-123 ”), during promotion to a Follow-Up Case, on the Case Compare page the system cannot match the Case Identifier to the record on the original Case. When Create Follow-Up is selected, an error message appears and the system prevents Follow-Up Case creation.
Workaround
On the Case Compare page, manually match the Case Identifier on the Inbox Item to the Case before selecting Create Follow-Up.
Inbox Items Cannot Be Created if Organization Field is Hidden
SAF-26418
When creating an Inbox Item, if the Organization field is hidden from the page layout, the following errors occur:
- The Organization field is not automatically populated as expected
- Company Products and Studies do not appear in the dropdown fields
Due to these errors, Inbox Item creation is prevented.
Migrated Cases Not Automatically Indexed for Duplicate Search
SAF-27780
When Cases are imported using migration user, the Imported Cases are not automatically indexed for duplicate case detection.
Partial Date of Birth Not Imported from E2B(R3)
SAF-28779
When importing an E2B(R3) file, if the Date of Birth is a partial date (for example, YYYY), the Date of Birth field is blank on the Inbox Item.
Workaround
Use the Calendar pop-up tool to select a date or enter the date manually.
Partial Dates in Some Field Combinations Can Prevent Inbox Item Creation
SAF-28723
When creating an Inbox Item, if a mixture of precise dates (for example, YYYY/MM/DD) and partial dates (for example, YYYY) is used for specific field combinations, and those dates include the same year, the system prevents Inbox Item creation. Issues occur in the following field combinations:
| Precise Date Entered | Partial Date Entered |
|---|---|
| Medical History > Onset field | Medical History > Cessation field |
| Products > Dosage > First Admin Date field | Products > Dosage > Last Admin Date field |
In any of the following fields:
|
Patient > Date of Death field |
Workaround
Use the same level of date precision in all of the above fields.
Receipt Date Field On a Non-E2B Source File Not Carried to New Info Date Field on an Inbox Item
SAF-27863
When you create an Adverse Event Report from a non-E2B source file with a date in the Receipt Date field, the date is not applied to the New Info Date field on the Inbox Item.
Workaround
Manually add the date to the New Info Date field.
Relatedness Records Not Imported Correctly from E2B(R2)
SAF-27954
When importing an E2B(R2) file that includes multiple Adverse Events with the same MedDRA code, the Case Assessment records are not imported correctly. For example, this situation can occur when the E2B file contains multiple adverse events sharing the same reaction MedDRA code but different verbatim terms.
Case Processing
Cannot Add More Than Ten Dosage Records to a Case Product
SAF-28074
Adding more than ten Dosage records to a Case Product is prevented by the system.
Cannot Change Rank of Case Product with a Substance when Linked to a Localized Case Product
SAF-27681
On a global Case, when trying to update the rank of a Product with a Substance to a Product without a Substance, an error appears if the Product with a Substance is on a linked Localized Case.
Incorrect Local Datasheet Expectedness When Precise Expectedness and Unexpected Seriousness Criteria are Enabled
SAF-27961
When a Local Datasheet inheriting terms from a Core Datasheet is set to Enable Precise Expectedness and a value is set for Unexpected Seriousness Criteria on both the Core and Local datasheets, then the Case Assessment Expectedness is generated using the Core Datasheet instead of the Local Datasheet.
Workaround
There are two ways to update the Case Expectedness field. For more information, see Override Case Expectedness or Listedness.
Localized Case Missing Narrative Document When No Localization Specified on Global Case
SAF-25583
When a Global Case has no Localization specified but includes a product that is registered in another country where the Case is also reportable, after Case Approval the narrative document is missing on the Localized Case.
Localized Follow-Up Case Link Missing on Narrative Document
SAF-26917
When creating a Follow-Up Case from a global Case using the Create Follow-Up Case user action, the Localized Follow-Up Case link is not populated on the localized Narrative document. If a Follow-Up Case is created from an Inbox Item, links are populated as expected.
MedDRA Preferred Terms Excluded from Deep Duplicate Search
SAF-29296
When enabled, the Deep Duplicate Search feature causes the system to exclude Preferred Terms (PT) when comparing the Event (MedDRA) field during duplicate case detection. The system compares using only Lowest Level Terms (LLT), which may result in missing potential matches.
Missing Translations on Case Dropdown Lists
SAF-26841, SAF-27096, SAF-27097
When performing data entry or translation to a non-English language, regardless of the setting on the Language field of the User Profile, dropdown fields appear in English on the following Case fields:
| Section | Field |
|---|---|
| Patient |
|
| Contact |
|
| Product |
|
Promote to Multiple Cases Overwriting nullFlavor with “PLACEHOLDER”
SAF-28523
For an Inbox Item, if the Patient Initials field is set to a Reason Omitted, when the Promote to Mutiple Cases action is used the system overwrites the value with “PLACEHOLDER” during promotion.
SDK Jobs Blocked by Case Locking
SAF-28203
When a Case is locked, the system prevents SDK jobs from updating the Case and its child records.
Safety Report Generation
Custom E2B Format Based on EMA E2B(R3) Applies Wrong RoA Version
SAF-28256
When using EMA E2B(R3) as the base document type for a custom E2B format, the Patient RoA TermID Version and Parent RoA TermID Version E2B data elements are set to version 2.2, instead of 2.1.
Exported E2B Files Include Country-Specific Product Registration Details for All Countries
SAF-27877
When you run the Evaluate Reporting Obligations action on a Case with a product registered in multiple countries, the exported E2B files incorrectly include the country-specific registration details entered on the Case Product for all countries instead of just the registration in the target jurisdiction.
FDA E2B(R2) Submission Includes Extraneous Blocks for Combination Products with Device Constituents
SAF-28216
When an FDA submission includes combination products with device constituents, the product section in the E2B(R2) file includes extraneous blocks for non-device constituents, in addition to the required blocks for the drug and device combinations.
PMDA E2B(R3) Submission Excludes Custom Dose Text
SAF-27081
When processing a Domestic Case with a custom dose and the Localization field set to Japanese (Japan), data elements G.k.4.r.1 and G.k.4.r.8 are excluded from PMDA E2B(R3) files.
Submissions and Distributions
AE in Jurisdiction Rule Parameter Not Applied When Set to No
SAF-28534
When the “AE in Jurisdiction” rule parameter on a rule set is set to No, Vault Safety does not apply the Agency Rule. When the rule parameter is set to Yes, the Agency Rule is applied correctly.
Incorrect Most Conservative Product on Partner Distribution List
SAF-27998
When generating Distributions for Combination Product Constituents, the Reporting Family Product is not used as the most conservative product.
Regional Validation Rules Run Regardless of Reporting Destinations
SAF-28392
When running Evaluate Regulatory Conformance, the system determines where the Case is reportable and which validations to run based on the Product or Study Registration countries. As a result, regional validation rules may cause unnecessary validation failures on the Case.
