Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
The following fixes are introduced in 21R1. For details about fixes issues in the Vault Platform in 21R1, see the Vault Release Notes.
Safety
The following Vault Safety issues are fixed in 21R1.
Intake
| Category | Description | Issue Number |
|---|---|---|
| Case Promotion | Fixed an issue where potential matches were not ordered by matching score during duplicate detection. | SAF-14528 |
| Case Promotion | Fixed an issue where a Duplicate Key error could occur when promoting an AER to a Case. | SAF-14225 |
| E2B Import | Fixed an issue where E2B imports could not complete successfully for ICSRs with chunk encoding. | SAF-16735 |
| E2B Import | Fixed an issue where E2B import through either the Receive E2B API or AS2 Gateway failed if the file name was greater than 96 characters. | SAF-16402 |
| E2B Import | Fixed an issue where Dose units and Parent Route of Admin were not being mapped during E2B R2 import when the leading 0's were missing from those data elements in the E2B file. | SAF-15905, SAF-16183 |
| E2B Import | Fixed an issue where the system sent ACK responses in E2B R3 format, regardless of the format of the received E2B file. | SAF-15651 |
| E2B Import | Fixed an (FDA VAERS scenario 10) issue where you could not create Study Products of the type Combination Product. | SAF-14476 |
| E2B Import | Fixed an E2B import issue where certain FDA VAERS units of measurement could not be mapped to a valid UCUM code and fields were instead being mapped to free text. | SAF-14377 |
| E2B Import | Fixed an issue where the E2B Import would not proceed and would not display an error message. | SAF-14306 |
| E2B Import | Fixed an issue where an error would occur when creating an AER from an imported E2B file. | SAF-12826 |
| E2B Import | Fixed an issue where the Create AER from Document Action would be displayed before the document rendition was completed. | SAF-12004 |
| E2B Import | Fixed an issue where product indications were not being imported and duplicate Case Products were being created. | SAF-15685 |
Case Processing
| Category | Description | Issue Number |
|---|---|---|
| Data Entry | Fixed an issue where certain EMA units of measurement codes were not mapped in Vault Safety. | SAF-16992 |
| Data Entry | Fixed an issue where empty Case Product Dosage records were being added after opening a Case with Study Arms. | SAF-15867 |
| Data Entry | Fixed an issue where the "Unit" placeholder text was missing on certain unit measure fields. | SAF-15151 |
| Data Entry | Fixed an issue where the Gestation value would appear as "Null" on a potential match when the Gestation field has no value. | SAF-15143 |
| Data Entry | Fixed an issue that resulted in a Vault Field being empty for FDA.D.1j. | SAF-14459 |
| Data Entry | Fixed an issue where a system error would occur when adding an External Product to a Case while in the Medical Review lifecycle state. | SAF-14337 |
| Data Entry | Fixed an issue that would result in a date validation error on other sections not being removed after removing DoD. | SAF-13482 |
| Data Entry | Fixed an issue that would prevent users from creating a picklist custom entry with a name that already exists. | SAF-11309 |
| Follow-Ups | Fixed an error that would occur while creating follow up from a Case with study arms, where Snapshotting is set to When case is opened. | SAF-13601 |
| Follow-Ups | Fixed an issue where duplicate dosages were created when a follow-up is created from a Case with Blinded Study Arms. | SAF-13600 |
| Medical Review | Fixed an issue where the medical review timeline was not loading. | SAF-13507 |
| Snapshotting | Fixed an issue where Product (Coded) was not being snapshot to Study Arm Case Products unless the Product Registration was removed. | SAF-16445, SAF-15869 |
Coding
| Category | Description | Issue Number |
|---|---|---|
| MedDRA | Fixed an issue that resulted in the terms from the new MedDRA version 24.0 not showing up on a search result. | SAF-16194 |
| MedDRA | Fixed an issue where the MedDRA coded term was not being cleared when the reporter term value was cleared. | SAF-15691 |
| MedDRA | Fixed an issue that resulted in an error which made users unable to Process EMA R3 Date. | SAF-15570 |
| MedDRA | Fixed an issue by updating the hovercard for meddra control to state "Parent MedDRA Version" instead of Case Meddra Version. | SAF-14633 |
| MedDRA | Fixed an issue where the MedDRA browser version was using the active version in Business Admin instead of using the Case MedDRA Version for Case Drug History and Case Diagnoses records. | SAF-13462 |
Aggregate Reporting
| Category | Description | Issue Number |
|---|---|---|
| PBRER | Fixed an issue where the PBRER Summary Tabulation was counting Case Adverse Events multiple times when there were multiple Case Products with multiple Case Assessments. | SAF-16342 |
Report Generation
| Category | Description | Issue Number |
|---|---|---|
| CIOMS I | Fixed an issue where a duplicate CIOMS document was created when the Generate CIOMS Preview action was performed. | SAF-13016 |
| E2B Export | Fixed an issue that resulted in the E2B R3 export - wrong Case Identifier element # in comments. | SAF-5061 |
| E2B Export | Fixed an (FDA VAERS scenario 9/10) issue where you could not create Study Products of the type Combination Product. | SAF-14460 |
| E2B Export | Fixed an (FDA VAERS scenario 6) issue where the blinded section in generated VAERS E2B R3 files caused XSD validation to fail. | SAF-14385 |
| E2B Export | Fixed an issue with E2B (R3) exports where a blank autopsy section (D.9.3) was included when there was no death, causing submissions to the EMA Gateway to be rejected. | SAF-14235 |
| E2B Export | Fixed an issue with all malfunction, no patient FDA VAERS scenarios, where VAERS E2B R3 files contained Middle name and street line 2 data. These fields will now be set to None in these scenarios. | SAF-14213 |
| FDA 3500A | Fixed an issue that resulted in the FDA3500 Date of Onset being Blank instead of "**-***-****" when If AE.Event Onset was Masked. | SAF-13456 |
Transmissions
| Category | Description | Issue Number |
|---|---|---|
| E2B Validation | Fixed an issue where Facility Type validation failed for a valid selection. | SAF-16132 |
| E2B Validation | Fixed an issue that resulted in the ICH: Validation Summary Downloaded CSV converting text to characters. | SAF-14019 |
| E2B Validation | Fixed an issue where transmissions with the Auto-submit feature enabled would transition to the Ready state when validation errors were present. | SAF-13925 |
| E2B Validation | Fixed an issue where the ICH.E.i.5-2 E2B validation rule failed for a valid Case Adverse Event Cessation Date. | SAF-13478 |
| E2B Validation | Fixed an issue where the ICH.D.2.1-2 E2B validation rule failed for Date of Birth referring to a future date when the Case Date of Birth field was not set to a future date. | SAF-13463 |
| E2B Validation | Fixed an issue where the ICH.F.r.4/5 E2B validation rule did not allow decimal numbers. | SAF-13435 |
| E2B Validation | Fixed an issue with E2B validation where the Validation Result Summary did not list IDs for records evaluated with the ICH.G.k.4.r.1a validation rule. | SAF-13424 |
| E2B Validation | Fixed an issue with E2B validation where the Validation Result Summary did not list vault fields evaluated with the ICH.D.10.3-3 and ICH.D.10.8.r.5-3 validation rules. | SAF-13421 |
| E2B Validation | Fixed an issue where the system contained a validation criteria (ICH.F.r.3.2-3) that could not be verified since the nullflavor field did not exist for Test Result (value / qualifier). This validation criteria has been removed. | SAF-11528 |
| Gateway Transmissions | Fixed an issue with submissions to FDA CBER/CDER gateway, where if a Case had multiple attachments, a single attachment was sent multiple times instead of sending each attachment. | SAF-17144 |
| Gateway Transmissions | Fixed an issue where regulatory conformance rules would not validate a Case with the country code XI (Northern Ireland). | SAF-16031 |
| Gateway Transmissions | Fixed an issue where the regulatory conformance of a follow-up Case could not be evaluated, resulting in an error. | SAF-16023 |
| Gateway Transmissions | Fixed an issue where an SDK error could occur when validating a Case with the Evaluate Regulatory Conformance action. | SAF-14703 |
| Gateway Transmissions | Fixed an issue where the E2B ACK warning is unexpectedly displayed when an EMA submission is submitted to gateway. | SAF-14651 |
| Gateway Transmissions | Fixed an (FDA VAERS scenario 6) issue where CBER VAERS E2B transmissions were rejected for missing medical history even when the file contained medical history. | SAF-14444 |
| Gateway Transmissions | Fixed an issue that resulted in, Non-Clinical Trial EMA Submissions destination defaulting to EVCTM. | SAF-14310 |
| Gateway Transmissions | Fixed an issue where a Case may be rejected by VAERS when the Case contained a Malfunction without an Adverse Event, or Patient Info, and the Drug Role was set to "Drug Not Administered." | SAF-13931 |
| Gateway Transmissions | Fixed an issue where the Medical History, Race, and Ethnicity fields on a case were not exported to a submitted report with Vaccine information included. | SAF-13909 |
| Gateway Transmissions | Fixed an issue where gateway transmissions with validation errors became stuck in the Sending ICSR state. | SAF-13432 |
| Gateway Transmissions | Fixed an issue where the ACK 2 record was not created when the record was received at the same time as an ACK 1 record. | SAF-10286 |
| Report Generation | Fixed an (FDA VAERS scenario 3) issue where, if the Patient Initials/ID field was blank for a malfunction case with a patient, then E2B file generation fails without notifying the user. | SAF-13926 |
| Reporting Rules | Fixed an issue where an error appeared when evaluating reporting obligations for a Case with registrations to an inactive agency without submission rules configured. | SAF-14396, SAF-14639 |
| Transmission Generation | Fixed an issue where, when both an active and inactive Transmission Profile exist for the same reporting destination, the system incorrectly matched Cases with the inactive Transmission Profile, causing validation errors. | SAF-15841 |
| Transmission Generation | Submissions are generated when the Case Product Drug Role is set to Concomitant or Drug Not Administered. | SAF-14314 |
| Transmission Generation | Fixed an issue where the destination for non-clinical-trial EMA Submissions defaulted to EVCTM | SAF-14310 |
| Transmission Generation | Fixed an issue where an error would prevent a FDA VAERS R3 file from being generated. | SAF-13855 |
System
| Category | Description | Issue Number |
|---|---|---|
| Audit Log | Fixed an issue where Optimistic Lock errors were included on the Customer Email Statistics log. | SAF-13719 |
| Audit Log | Fixed an issue where the Audit Trail did not record the number of results returned by duplicate detection. | SAF-11957 |
| Performance | Fixed an issue causing a server error to appear when accessing a Case Product. | SAF-15400, SAF-16919 |
| Performance | Fixed an issue where a decrease in system performance would occur during Assign Due Date on the Case lifecycle. | SAF-11086 |
| Object Administration | Fixed an issue where case_number_v.name_v could be set to a custom configuration that prevented generation of Case Assessments due to record names exceeding the maximum character limit. | SAF-17287 |
Safety.AI
The following Vault Safety.AI issues are fixed in 21R1.
Intake
| Category | Description | Issue Number |
|---|---|---|
| Case Promotion | Fixed an issue where the Receipt Date is not applied to the New Info Date on the Inbox Item upon Case Promotion. | SAF-15278 |
| Data Extraction | Fixed an issue during automated intake where an Inbox Item was not created if Case Contact information was extracted from unstructured data. | SAF-14365 |
| Data Extraction | Fixed an issue where, when the AI service is skipped (skip_api = true) to create an inbox item via API, the Type field on Product and Event records from structured data were not being autopopulated. | SAF-13996 |
| Verification | Fixed an issue that resulted in a conflict snippet not being crossed out after a user deletes > undo record. | SAF-14116 |
| Verification | Fixed an issue where a server error appeared when saving a Case Product after deleting a Dosage and the Case Product, and then undoing the delete of the Case Product. | SAF-15929 |
| Verification | Fixed an issue where, after editing the Inbox Item Reciept Date and Report Type (for the first time) and refreshing the page, the changes are not saved. | SAF-15418 |
| Verification | Fixed an issue where, if a Safety.AI vault received an Inbox Item from the API with a time specified in the Receipt Date structured data (JSON), users could not verify the Details section on the Inbox Item. | SAF-15082 |
System
| Category | Description | Issue Number |
|---|---|---|
| UI/UX | Fixed a UI issue by adjusting confidence Icon size UI issues on IE. | SAF-15858 |
| UI/UX | Fixed an issue that resulted in the Case contact subheadline not updating to 'Reporter'. | SAF-14402 |
Transmissions
| Category | Description | Issue Number |
|---|---|---|
| Transmission Generation | Fixed an issue where users could not generate transmission documents on Promotion-type Transmissions. | SAF-13232 |
