A maintenance release contains fixes for issues affecting customer Vaults in production environments. Maintenance releases can occasionally include enhancements, for example, a time-sensitive regulatory requirement. This page covers maintenance releases deployed to General Release Vaults only. We communicate 24 hours prior to a maintenance release. There may be a short service disruption during deployment. The Veeva Trust Site provides the most up-to-date information on Vault’s service status. Check this site to view the current status of Vault PODs and upcoming scheduled system maintenance.
This list only covers fixes for issues that impact 22R3 General Release versions of Safety Vaults. The list of fixed issues is subject to change until the release occurs. When we identify issues to fix in a maintenance release, we attempt to get them into the earliest release possible. Sometimes, we target a specific release but are not able to deliver a fix early enough for full testing. In situations like this, we postpone the fix for a later release and strike out the description in this list.
We number maintenance releases for Safety by appending the number of the Safety-specific maintenance release to the General Release number. The most recent Vault General Release is 22R3.0, so our maintenance releases for this version are 22R3.0.2, 22R3.0.3, and so on.
Vault frequently delivers Platform maintenance releases. Safety deploys these Platform maintenance releases at a later date, along with any required fixes to Safety. For details on Platform fixes in these maintenance releases, see 22R3 Maintenance Releases.
Last Updated: April 30, 2023
April 20, 2023
Release Number: 22.3.0.20 | Build Number: 589
| Description | Issue No. |
|---|---|
Fixed an issue where, when 22R3 deep duplicate detection was enabled, in some instances Promote to Case was prevented when Inbox Items included the words and, not, or orin Adverse Event or Product fields. |
SAF-40685 |
| Fixed an issue on the Potential Matches page where, when 22R3 deep duplicate detection was enabled, some Inbox Item Case Identifiers for migrated Cases were not considered during duplicate detection. | SAF-41154 |
April 11, 2023
Release Number: 22.3.0.19 | Build Number: 585
| Description | Issue No. |
|---|---|
| Fixed an issue with email Transmissions where, when voiding a Case and nullifying all previous Transmissions, the New Info Date token in the message body was populated based on the previous version of the Transmission. | SAF-38266 |
April 4, 2023
Release Number: 22.3.0.18 | Build Number: 583
| Description | Issue No. |
|---|---|
| Fixed an issue on the Potential Matches page where, when 22R3 deep duplicate detection was enabled, Inbox Item Case Identifiers were not considered during duplicate detection. | SAF-39869 |
| Fixed an issue where, when Expectedness was overridden at the Case Assessment level on a Study Case for a blinded Study, if the Case was unblinded the overridden value for Case Assessment Expectedness was cleared and Case Assessment (Status) was reset to Auto-calculated. This fix addresses an unexpected behavior change caused by SAF-34161, which has been reverted. | SAF-37392 & SAF-40201 |
March 30, 2023
Release Number: 22.3.0.17 | Build Number: 577
| Description | Issue No. |
|---|---|
| Fixed an issue where creating a pre-release sandbox from a sandbox Vault was prevented by the system. | DEV-568512 |
March 28, 2023
Release Number: 22.3.0.16 | Build Number: 568
| Description | Issue No. |
|---|---|
| Fixed an issue on the Potential Matches page where, when 22R3 deep duplicate detection was enabled, Case Identifiers were not considered when searching for potential matches. | SAF-39774 |
March 23, 2023
Release Number: 22.3.0.15 | Build Number: 567
| Description | Issue No. |
|---|---|
| Fixed an issue where, in some cases, users may have experienced performance issues when generating Narrative documents. | DEV-566588 |
March 14, 2023
Release Number: 22.3.0.14 | Build Number: 564
| Description | Issue No. |
|---|---|
| Fixed an issue where, when searching by Preferred Name in the WhoDRUG Browser, generic drugs were not returned in the search results. Now, you can filter on generic drugs by entering "generic:y" in the Search bar. | SAF-31080 |
| Fixed a caching issue that prevented the import of custom field values through E2B files. | SAF-35061 |
| Fixed an issue where, when Expectedness was overridden at the Case Assessment level on a Study Case for a blinded Study, if the Case was unblinded Expectedness at the Case Assessment level was cleared and reset to Auto-calculated and Expectedness at the Case level was also cleared. | SAF-37392 |
|
Previously, when merging to an In-Flight Case or creating a Follow-Up Case, if either the Inbox Item or matched Case included at least one Case child object that exceeded the system limit of 500 records, the action was prevented by the system. Now, Vault Safety supports up to 1,500 Case child objects on a maximum of three (3) objects. Enablement: Support |
SAF-37884 |
March 7, 2023
Release Number: 22.3.0.13 | Build Number: 552
| Description | Issue No. |
|---|---|
| Fixed an issue with Case promotion where, when the Potential Matches page included both likely and possible matches, the possible match results were not ranked in the correct order. | SAF-37847 |
| Fixed an issue where Products with a Drug Role of "Similar Device" were being included on non-FDA Transmission documents. | SAF-38225 |
| Fixed an issue where, when the Device Code entered in the Case Product Device Code field was not a level 3 code, the corresponding FDA code was not exported to FDA E2B(R2), FDA VAERS E2B(R3), and FDA 3500A files. | SAF-38235 |
| Fixed an issue with FDA E2B(R2) export where, when a Combination Product included Drug and Company Product constituents and the Company Product had a Drug Role of "Similar Device", the Company Product was not included in a B.4 Drug(s) Information block of the file. | SAF-38297 |
| Fixed an issue where, when a Study was set up with Unspecified Products, Watchlist tags were not applied to associated Study Cases. Now, when a Study has Unspecified Products, Watchlist tags are applied to Case Products. | SAF-38355 |
| Fixed an issue where, when a Case Contact Reporter Country value was deleted on an Inbox Item, during Case promotion, the system included the deleted value in the duplicate detection matching criteria. | SAF-38545 |
February 28, 2023
Release Number: 22.3.0.12 | Build Number: 544
| Description | Issue No. |
|---|---|
| Fixed an issue where, when a Case Product had a Drug Role of Concomitant and the related Dosage record had partial dates (for example, YYYY-MM) in the First Admin Date or Last Admin Date fields, the New Case - Copy Patient Information action was prevented. | SAF-36913 |
| Fixed an issue with Case promotion where, in some instances, the Potential Matches page did not appear and a system error was displayed but the Inbox Item was promoted. | SAF-38785 |
| Fixed an issue with Cases created through E2B-import where some fields were not considered during duplicate detection. | SAF-38573 |
| Fixed an issue where, when an Inbox Item was merged to an in-flight Case and the Adverse Event was changed, after the merge the Case Assessment name was not updated, although the Case name and Adverse Event record were updated correctly. | SAF-35938 |
| Fixed an issue where, when a Case included a Company Product with a Product Type of Device and the associated Malfunction field was set to Yes, the Case-level Device Report Type field was not populated with "Malfunction". | SAF-38312 |
| Fixed an issue with generating FDA E2B(R2) files with device-specific adverse events where International Medical Device Regulators Forum (IMDRF) codes for Medical Device Problems and Investigation Conclusions were not exported correctly. | SAF-35844 |
| Fixed an issue with E2B export where values in the Study Name (Continued) field were not populated in the C.5.2 Study Name data element of E2B(R3) files. | SAF-36184 |
February 21, 2023
Release Number: 22.3.0.11 | Build Number: 535
| Description | Issue No. |
|---|---|
| Fixed an issue with promoting Cases from the Case Compare page where, when an error occurred due to missing Read permission for the Language field, the system error message did not describe the cause of the issue. | SAF-37207 |
| Fixed an issue where, when the Potential Matches screen returned more than 20 results, reviewing the left pane list of all potentially matching Cases was difficult. The pane now includes a scrollbar for better usability. | SAF-38284 |
| Fixed an issue where, when sending Submissions and Distributions over email, the full email body was captured in the Initial Message Sent event type of the Email Events Log. This created the potential for personally identifiable information (PII) to appear in the log. | SAF-38460 |
| Fixed an issue where, when an Inbox Item had its Localization set to Korean (South Korea), after saving, although local and English values were entered in the dual-entry Indication field, the local-language Indication field was blank and the local value appeared in the English-language Indication field. | SAF-38461 |
| Fixed an issue on the Potential Matches page where, when 22R3 deep duplicate detection was enabled, selecting a link to an imported Case resulted in a Page Not Found error. | SAF-38577 |
February 14, 2023
Release Number: 22.3.0.10 | Build Number: 529
| Description | Issue No. |
|---|---|
|
Previously, the most conservative product and assessment rule parameter evaluation strictly relied on Case Seriousness, Expectedness, and Relatedness being defined in the Distribution Rules. This can lead to under-reporting for common rule sets. Vault Safety can now employ a more tolerant rule parameter evaluation based on the configuration of relevant reporting rules. Enablement: Support Default Impact: None GxP Risk: High |
SAF-34690 |
| Fixed an issue with 22R3 deep duplicate detection where Study Number was included in the ID match criteria, resulting in too many Likely Match suggestions. Now, Study Name and Study Number are included in the Matching Reporter criteria. | SAF-37574 |
| Fixed an issue where, when auto-calculation was turned off, Age fields were auto-calculated after Case promotion for Inbox Items created through E2B-import. | SAF-37874 |
| Fixed an issue where, when the Reporting Rule Product Parameter was set to Combination Product, Transmissions were generated for both Combination Products and Product Constituents. Now, Transmissions are generated only for Combination Products. | SAF-38036 |
| Fixed an issue with automated Case promotion where, when 22R3 deep duplicate detection was enabled and set to consider Inbox Items, promotion failed when the most likely ID match was an Inbox Item. | SAF-38058 |
February 7, 2023
Release Number: 22.3.0.9 | Build Number: 510
| Description | Issue No. |
|---|---|
|
With this release, Vault Safety will use improved logic to determine the product driving ICSR reporting requirements in cross reporting scenarios. Enablement: Support Default Impact: Visible to Admins Only GxP Risk: High |
SAF-33342 |
| Fixed an issue where Watchlist Tags were applied to Cases when the associated Organization was not on the Watchlist record. | SAF-34282 |
| Fixed an issue where, when strict case locking was enabled, Vault Owners were prevented from editing Cases. | SAF-35166 |
| Fixed an issue with E2B-imported Cases where the Blinded Name (Placeholder) field on the Case Product record was not populated when the reported name was an exact match for the Blinded name. | SAF-35176 |
| Fixed an issue on the Potential Matches page where, when deep duplicate detection (option 3) was enabled, the Compare Details button did not appear when Inbox Items were matched to E2B-imported Cases. This prevented creating Follow-up Cases or merging to In-flight Cases. | SAF-38057 |
January 31, 2023
Release Number: 22.3.0.8 | Build Number: 502
| Description | Issue No. |
|---|---|
| Fixed an issue with FDA 3500A report generation where, when Case Relatedness changed from Related to Unrelated, the G.7. Type of Report field was set to "Periodic". Now, when Relatedness is downgraded, the field is populated based on the Due in Days reporting rule parameter, when a value exists. Otherwise, existing system logic is applied. | SAF-31849 |
| Fixed an issue with E2B(R3) validation where the EMA.C.5.1.r.1 data element always required that the Study Registration Number was populated with a valid unique EU trial number or EudraCT number. Now, this validation criteria applies only to Transmissions to the EudraVigilance Clinical Trial Module (EVCTM). | SAF-34818 |
| Fixed an issue with E2B(R2) import where, when a file included thousands of Cases, in some instances not all Cases were imported successfully. | SAF-35077 |
|
Fixed an issue with CIOMS I and FDA 3500A preview generation for Study Cases without Case blinding, when a blinded Study included open Study Arms, the report data was masked. Now, when a Study Case is not set to be blinded and the blinded Studies included open Study Arms, Vault Safety includes the option to generate unmasked report previews. Enablement: Support |
SAF-35118 |
|
Fixed an issue where, when atomic security was configured to hide fields with protected health information (PHI) and personally identifiable information (PII), some values still appeared on the Potential Matches page during Case promotion. Now, Vault Safety includes the option to hide all Reporter, Patient, and Adverse Event Onset field values on the Potential Matches page. Enablement: Support |
SAF-37499 |
January 26, 2023
Release Number: 22.3.0.7 | Build Number: 497
| Description | Issue No. |
|---|---|
|
With this release, Vault Safety improves the user interface for locked Cases. Now, when a Case is locked, either through manual or strict case locking, actions that cannot be used are excluded from the All Actions menu. This prevents starting actions that the system can't complete on locked Cases. This improvement affects only the user interface and contains no functionality changes. Enablement: Auto-On Default Impact: Visible to All Users GxP Risk: Low |
SAF-32995 |
|
Vault Safety now gives Case Processors the ability to generate Assessments, Assessment Results, and Expectedness records for all serious and non-serious Adverse Events on a Case. Completed in a single action, this feature improves Case processing efficiency by removing the need to generate each required record manually. Enablement: Support Default Impact: None GxP Risk: Medium |
SAF-34997 |
| Fixed an issue with evaluating the Downgrade reporting rule parameter for Clinical Trial Cases where, when the Safety Rule Set had Product Selection set to "Most Conservative Product", the most conservative product on the original Case was not considered. Now, the most conservative product on both the original and Follow-up Case is evaluated to determine if the Clinical Trial Case's seriousness, expectedness, and relatedness have been downgraded or upgraded. | SAF-36440 |
| Fixed an issue where, when promoting an Inbox Item and merging it into an in-flight Case or creating a Follow-up Case, if a Case child object on either the Inbox Item or the matched Case exceeded the system limit of 300 records, none of the Inbox Item records for that object were applied to the new Case version. Now, the system limit for Case child objects is 500 records. | SAF-37528 |
| Fixed an issue with Strict Case Locking where, when Assign Due Date was configured as an Entry Action and included in the Case Locking criteria, moving Cases to the Approved state was prevented by the system. | SAF-37656 |
| Fixed an issue where, when Strict Case Locking was enabled, after promoting an Inbox Item to multiple Cases only the first created Case entered the Triage lifecycle state. | SAF-37657 |
January 18, 2023
Release Number: 22.3.0.6 | Build Number: 489
| Description | Issue No. |
|---|---|
|
Fixed an issue where Cases did not appear on PADER 15-Day and Non-15 Day Summary Reports due to page count limitations. Now, 15-Day and Non-15 Day Summary Reports can include up to 7,500 Cases. Enablement: Support |
SAF-37607 |
January 17, 2023
Release Number: 22.3.0.5 | Build Number: 487
| Description | Issue No. |
|---|---|
| Fixed an issue where, when Follow-up Questionnaires were created for Inbox Items without a specified Company Product, the generic product template was not selected for the questionnaire and the questionnaire was not sent. | SAF-35889 |
| Fixed an issue with E2B import where, when the Auto-select Inbox Item Localization by Reporter Country feature was enabled and an Inbox Item had a Localization Type of Local, the system mapped the Name (Reported) field to the localized field instead of the global field (English). | SAF-35958 |
| Fixed an issue with E2B file export where, when a Case with a Combination Product also included a non-Combination Product with a Drug Role of "Similar Device", the Product with the Drug Role of "Similar Device" was exported to all E2B Transmission formats. Now, those Products are exported only to FDA E2B(R2) and FDA VAERS E2B(R3) formats. | SAF-35963 |
| Fixed an issue where, when voiding localized Follow-up Cases, generated Transmission records linked to the original Localized Case, instead of the Follow-up Case. | SAF-36554 |
| Fixed an issue with Localized Cases where values in the English Event (Reported) field were overridden with MedDRA terms when adverse events were coded through the MedDRA browser. | SAF-36617 |
| Fixed an issue where Read access permission for localized objects was required to view Inbox Items without localization. | SAF-36824 |
| Fixed an issue where, when a Transmission was created manually and then the Transmission Document Type was later changed to E2B, the E2B Message ID was not generated. | SAF-36831 |
| Fixed an issue with merging Inbox Items into in-flight Cases where Case identifiers doubled with each merge. This led to a high number of duplicate records with the potential to impact system performance. | SAF-37300 |
January 10, 2023
Release Number: 22.3.0.4 | Build Number: 479
| Description | Issue No. |
|---|---|
| Fixed an issue where, when voiding a Case and generating a Transmission with the One Last Time parameter set to "Yes", the Previously Submitted reporting rule parameter evaluated only the previous Case version. Now, all prior Case versions are evaluated and the Transmission is generated with the One Last Time parameter set to "Yes" only when the most recent Transmission for the same destination has the One Last Time parameter set to "No". | SAF-33974 |
| Fixed an issue with E2B import through API transmission where, in some instances, the Retrieve Job Status API call did not return acknowledgements after successful imports. | SAF-34985 |
| Fixed an issue where, when Inbox Items were created through email intake, the Receipt Date field was populated with the date the email was sent. Now, when Inbox Items are created through email intake, the Receipt Date field is left blank. | SAF-36707 |
| Fixed an issue where global Case data was not synchronized to follow-up foreign Localized Cases when the associated Transmission records were created by rules evaluation. | SAF-36713 |
Fixed an issue with manual Submission and Distribution creation where, when a Transmission Profile was selected, the system did not apply some settings to the Submission or Distribution record. Now, the following Transmission Profile settings are applied to the record:
Enablement: Support |
SAF-36734 |
| Fixed an issue where, when a Case with an External Product had a Localized Case Submission, changing the External Product and its Substance on a Follow-up Case was prevented by the system. | SAF-37129 |
December 16, 2022
Release Number: 22.3.0.3 | Build Number: 467
| Description | Issue No. |
|---|---|
| Fixed an issue with E2B(R2) file export where, when only a non-primary Case Adverse Event was Serious, the A.1.5.1 Serious data element was set to "No" although the A.1.5.2 Seriousness Criteria was set to "Yes" for the applicable Seriousness Criteria. Now, when any Case Adverse Event includes Seriousness Criteria, the A.1.5.1 data element is set to "Yes". | SAF-36441 |
| Fixed an issue where, when creating binders with custom document types, after selecting Save the system displayed an error message although the binder was saved. This issue did not prevent merging binder documents into a PDF. | SAF-36450 |
December 12, 2022
Release Number: 22.3.0.2 | Build Number: 463
| Description | Issue No. |
|---|---|
| Fixed an issue where, when promoting an AER to a Case, UID was not included in the potential match criteria. | SAF-36803 |
| Fixed an issue where, when promoting an AER to a Case, system performance was slow when running duplicate detection. | SAF-36803 |