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 21R3. For details about fixed issues in the Vault Platform in 21R3, see the Vault Release Notes.
Intake
| Category | Description | Issue Number |
|---|---|---|
| E2B Import | Fixed an issue with multi-Case E2B import where one of the Receipt Date fields was not populated upon import, which led to the Initial Receipt Date field being left blank on Follow-Up Cases. | SAF-21436 |
| E2B Import | Fixed an issue where a server error appeared when an Inbox Item was imported from E2B or from the Intake API with the Localization field set to Japanese. | SAF-20864 |
| E2B Import | Fixed an issue with manual and AS2 import where, when an E2B(R2) file with Origin ID set to MHRAUK was imported, the Origin field was not populated on the Inbound Transmission if the Destination ID fields from the E2B file and transmission profile did not match. | SAF-20843 |
| E2B Import | Fixed an issue where, when an AER was created from an E2B(R2) file, two additional Case Assessment Results were generated on the AER if the adverse event was populated with text but the MedDRA Code was missing. | SAF-20530 |
| E2B Import | Fixed an issue where MHRA E2B R2 Dose Forms (B.4.k.7) were imported as dose form term ID codes instead of descriptive dose form names. | SAF-16105 |
| E2B Import | Fixed an issue where the Local Report Number and Local Message Number fields were not populated on the generated E2B(R2) acknowledgment file. | SAF-21535 |
| E2B Import | Fixed an issue where the Study field was not set on an imported Case from E2B if the Product did not match any Study Products in the system. | SAF-21777 |
| E2B Import | Fixed an issue where, when an E2B was imported to Inbox Item and G.k.2.5 (Investigational Product Blinded) was not present for a Suspect, Interacting, or Drug not administered Product, Case Product Blinded and Case Blinded were set to No instead of null. | SAF-22760 |
| E2B Import | Fixed an issue where, when an E2B with an External Suspect Product was imported to Inbox Item, the External Product was mapped to a Study Product. | SAF-21081 |
| E2B Import | Fixed an issue where an error appeared when a migration user tried to import Cases in batch with an attached CSV file. | SAF-22671 |
| E2B Import | Fixed an issue where E2B(R3) files with a Dose Text (G.k.4.r.8) value exceeding 1499 characters failed to import. The E2B(R3) standard character limit is 2000 characters. | SAF-23559 |
| E2B Import | Fixed an issue where, if a Case was received from a source that was not an Agent for an E2B imported AER, the Case New Info Date was set using the original value. | SAF-23365 |
| Case Promotion | Fixed an issue where the normalized Height and Weight fields were not auto-calculated and were left blank upon promoting an Inbox Item to an Initial Case. | SAF-21604 |
| Case Promotion | Fixed an issue where a NullPointerException error appeared when promoting an AER (from E2B import) with a null receiptdate_date__v field to a Follow-Up Case. | SAF-21444 |
| Case Promotion | Fixed an issue where, when promoting cases in bulk, duplicate Cases were sometimes created from an AER if multiple operations tried to promote the same AER. | SAF-21288 |
| Case Promotion | Fixed an issue where the Cumulative Dose field was not auto-calculated after Case promotion from an Inbox Item, AER, or from the Case Compare Followup page. | SAF-21083 |
| Case Promotion | Fixed an issue where, when promoting an Inbox Item to Case, the Age at Onset and Age Group fields were not calculated and were left blank on the initial Case. | SAF-20113 |
| Case Promotion | Fixed an issue where the Product Registration information on an Open-Label or Single-Blinded Study was not carried over to the Case after promoting an Inbox Item. | SAF-21367 |
| Case Promotion | Fixed an issue where a "NullPointerException" error appeared when trying to promote an AER to Case if the Controlled Vocabulary Patient record was deprecated. | SAF-21778 |
| Case Promotion | Fixed an issue where the MedDRA version on Follow-Up Cases was not set properly after promoting an initial Case where the MedDRA version on Follow-Ups was set to use the previous Case version's. | SAF-21070 |
| Case Promotion | Fixed an issue where localized Cases were not copied from the Inbox Item or AER when promoting to Follow-Up from the Case Compare and Potential Matches page, respectively. | SAF-21186 |
| Case Promotion | Fixed an issue with domestic Case processing where, when an Inbox Item with a localized Product (Reported) value was promoted to Case, the localized Product (Reported) value was overriden by the global value on the Case. | SAF-22417 |
| Case Promotion | Fixed an issue where an Inbox Item that contains a blinded study but an unblinded product could not be promoted to Case. | SAF-23572 |
| Case Promotion | Fixed an issue where localized Cases were not copied from the AER when promoting to Follow-Up from the Potential Matches page. | SAF-24175 |
| Case Promotion, Follow-Up | An enhancement in 21R1 resolved an unidentified long text truncation issue affecting Case Test Result Comments (F.r.6), Result (Text) Field (F.r.3.4) and Medical History Comments (D.7.1.r.5). This occurred when a case was copied for Follow-up or AER case promotion. This fix allows Veeva to identify previously impacted cases and then, with an approved change control (CC), restore the truncated data from the original. Impacted customers have already been contacted to proceed with full impact assessment and repair. | SAF-21034 |
| Case Promotion | Fixed an issue where, when an Inbox Item with a set localization was promoted to Case, the adverse event reported language was overriden by the English translation on the Case. | SAF-21377 |
| Duplicate Detection | Fixed an issue where duplicates of the MRN field in the Patient section were not detected by duplicate detection and were not displayed on the Potential Matches page upon promoting an Inbox Item. | SAF-20781 |
| Duplicate Detection | Fixed an issue where duplicate detection was not populating the Worldwide UID (WWUID) field on the Case using the data from the Case Number, if the worldwide_uid__v field was added to Case Object Type. | SAF-18466 |
Case Processing
| Category | Description | Issue Number |
|---|---|---|
| Data Entry | Fixed an issue by modifying the MFDS and NMPA Controlled Vocabulary Record API Names to match their corresponding picklist value names. | SAF-21195 |
| Data Entry | Fixed a data compatibility issue with custom dose units entered on Inbox Items. | SAF-20478 |
| Data Entry | Fixed an issue where the Receipt Date calendar displayed a different date than the value entered in the field. | SAF-20475 |
| Follow-Ups | Fixed an issue where the Case field was not populated on a promoted Inbox Item when the Inbox Item was promoted to a follow-up Case version. | SAF-21435 |
| Follow-Ups | Fixed an issue where, when the initial Case version field was not properly set by a user on Follow-Up Cases, the Worldwide UID (WWUID) field was updated on the Follow-Up Case when fields monitored by the Case UID (Event Country, Product, Study) changed. Now, once the WWUID field is populated on a Case, it does not update even if the Case UID is updated. | SAF-21609 |
| Narratives | Fixed an issue where an inactivated narrative template was being used instead of the base template when creating a narrative from a Case. | SAF-20898 |
Coding
| Category | Description | Issue Number |
|---|---|---|
| MedDRA | Fixed an issue where, when a Japanese MedDRA term containing more than one character was searched for, the search did not return any results. | SAF-21109 |
| MedDRA | Fixed an issue where auto-coding in Japanese MedDRA was returning the incorrect English term and code. | SAF-21110 |
| MedDRA | Fixed an issue with E2B(R3) mapping where the Event (Reported) field was mapped as a native term when the language was set to English or left blank. | SAF-20822 |
Aggregate Reporting
| Category | Description | Issue Number |
|---|---|---|
| DSUR | Fixed an issue with the unmasked DSUR Cumulative Tabulation of Serious Adverse Events from Clinical Trials report where the same adverse event could be counted in both the Blinded and Placebo columns when there are multiple versions of the Case. | SAF-20353 |
| DSUR | Fixed an issue with the DSUR Cumulative Tabulation of Serious Adverse Events from Clinical Trials report where, when a Case was downgraded from Serious to Non-Serious, the report did not display the latest Case version within the reporting period. | SAF-20231 |
| DSUR | Fixed an issue where the DSUR Appendix: Cumulative Summary Tabulation of SARS was including unrelated serious adverse events in the report. | SAF-20205 |
| DSUR | Fixed an issue with the unmasked and masked DSUR Interval Line Listings of Serious Adverse Reactions where the generated report did not include the latest version for a downgraded (serious to non-serious) Case. | SAF-20464 |
| DSUR, PBRER |
Fixed an issue with the DSUR and PBRER Cumulative Tabulation of Serious Adverse Events and the DSUR Cumulative Tabulation of Serious Adverse Reactions, where the aggregate reports failed to generate when the dataset contained one or more Cases with no primary Case Product. | SAF-20947 |
| PADER | Fixed an issue where, when generating a PADER without a local datasheet set up, only the expectedness of the primary Case Adverse Event was considered in the PADER Summary of ADR from Postmarketing Sources report. Now, the report evaluates the expectedness on the Case Assessment for each Case Adverse Event. | SAF-20439 |
| PADER | Fixed an issue with PADER Interval Line Listings where, if the Case Transmission Date was the same as the Data Period End, the Transmission Date was displayed as "-" in the date column on the aggregate report. | SAF-21393 |
Report Generation
| Category | Description | Issue Number |
|---|---|---|
| CIOMS I, FDA 3500A |
Fixed an issue where the "Date Received by Manufacturer" field was always being mapped from the Case New Info Date. Now, Vault Safety has logic to populate this field from the Case Receipt Date for initial cases, and from the New Info Date for follow-up cases. | SAF-21064 |
| E2B Export | Fixed an issue with custom E2B+ SDK xml formats, where the system did not send a notification when it could not generate a custom Transmission file successfully and instead generated a blank file. | SAF-20139 |
| E2B Export | Fixed an issue where G.k.2.2 was not populated due to the Product (Reported) field being blank on E2B export. Now, if Product (Reported) is blank for Open-Label studies, the system populates it using Product (Coded). For Blinded studies, the system populates Product (Reported) with Blinded Name (Placeholder), when creating a Case Product. When unblinding a Study Product, if the Product (Reported) field is blank or populated with the Blinded Name (Placeholder) value, the system populates the field using Product (Coded). | SAF-20710 |
| FDA 3500A | Fixed an issue where the Age field was not populated on the FDA 3500A form after report generation if only Age (normalized) was present. Now, if the Age value is blank on the Case, the Age (normalized) field (if present) will be exported and set as the Age on the FDA 3500A form. | SAF-22017 |
| Masked Distributions | Fixed an issue where Case Product Dosages could not be masked during report generation for blinded report previews and masked distributions, including CIOMS I, FDA 3500A, E2B R2, and E2B R3 report formats. You can now request, by support enablement, to mask dosage information for blinded report previews and masked distributions. Unless this behavior is requested and enabled, report generation continues to populate dosage information by default. | SAF-21618 |
Transmissions
| Category | Description | Issue Number |
|---|---|---|
| Gateway Transmissions | Fixed an issue where, when two custom gateway profiles with the same Sponsor and Health Authority ID combination were saved, an error notification stated "Error updating profile" instead of stating the required details. | SAF-21093 |
| Gateway Transmissions | Fixed an issue where, when FDA CBER VAERS and FDA ESG were configured with the same Sponsor ID and Health Authority ID, an error appeared when trying to save the Gateway Profiles. | SAF-20881 |
| Gateway Transmissions | Fixed an issue by advising users to use Receive Port 8080 because Vault Safety does not support sending MDNs (Message Delivery Notifications) on Port 4080 at this time. | SAF-22099 |
| Submissions | Fixed an issue where, when an FDA Submission was generated for a Study with Due Date Override enabled, the incorrect FDA Report Type was selected. | SAF-22942 |
| E2B Validation | Fixed an issue where an error appeared upon E2B(R3) import for the Test Result field (F.r.3.2) due to the value exceeding the maximum value limit. This resulted in the ICSR entering Error state. | SAF-21892 |
| E2B Validation | Fixed an issue where, when the Re-evaluate Submission Distribution action was run on a Case, the EMA.G.k.4.r.7 validation rule passed even when there was no Case Product Dosage and G.k.4.r.7 (Batch/Lot Number) was not exported in the EMA E2B(R3) file. | SAF-22825 |
| E2B Validation | Fixed an issue where, when the Re-evaluate Submission Distribution action was run on a Case, the EMA.G.k.4.r.7 validation rule failed even when there was a Case Product Dosage and G.k.4.r.7 (Batch/Lot Number) was set with a valid nullFlavour value (UNK). | SAF-22824 |
| E2B Validation | Fixed an issue where validation errors occurred for EMA.G.k.4.r.7 when the Evaluate Regulatory Conformance action was run on a Case, even when G.k.4.r.7 (Batch/Lot Number) was populated on the Case Product Dosage. | SAF-21336 |
| Reporting Rules | Fixed an issue where, when the Evaluate Submission Obligations action was run on a Case where the non-primary assessment was a SUSAR, no FDA submissions were generated. | SAF-19863 |
| Transmission Generation | Fixed an issue where, the generation or regeneration failed for an E2B(R2) transmission document due to the adverse event records setting the Primary field to null upon promoting an Inbox Item to a Follow-Up Case. | SAF-22858 |
Document Management
| Category | Description | Issue Number |
|---|---|---|
| Merge to PDF | Fixed an issue where, in some cases, the Merge to PDF document action could not complete successfully. | SAF-21486 |
System
| Category | Description | Issue Number |
|---|---|---|
| Performance | Fixed an issue where system performance was slow during the Promote to Case action. | SAF-21262 |
| Vault Management | Fixed an issue where a server error appeared when a user tried to view a Case Test Result in Vault Management Console (VMC) > View Configuration. | SAF-21039 |
| Object Administration | Fixed an issue where the API Names of the Controlled Vocabulary records for the OTC Drug Channel field was not in sync with the corresponding picklist value names. | SAF-21142 |
