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 21R3 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 21R3.0, so our maintenance releases for this version are 21R3.0.1, 21R3.0.2, 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 21R3 Maintenance Releases.
Last Updated: August 12, 2022
March 31, 2022
Release Number: 21.3.0.15 | Build Number: 601
| Description | Issue No. |
|---|---|
| Fixed an issue with ICH E2B(R2) reports where the DOCTYPE DTD (document type definition) could not be modified. | SAF-19096 |
March 24, 2022
Release Number: 21.3.0.14 | Build Number: 585
| Description | Issue No. |
|---|---|
| Fixed an issue where notifications with the subject line "PV/DL Case Transfer Status Update Period Job did not finish successfully" were being sent by the system. Now, the PV and DL jobs are set to inactive to prevent further notifications. These jobs did not impact other Vault Safety processes. | SAF-27283 |
March 17, 2022
Release Number: 21.3.0.13 | Build Number: 574
| Description | Issue No. |
|---|---|
| Fixed an issue where, when sending a file through an AS2 gateway, the Transmission records went to the MDN Failure state. | SAF-22799 |
| Fixed an issue where, when an ICH E2B(R2) regulatory report was generated, the header contained "FDA". | SAF-24548 |
| Fixed an issue where an error appeared when a user tried to load more than 250 Case Assessment records in one batch using Vault Loader. | SAF-26073 |
| Fixed an issue where, when an Inbox Item with Localization set to a non-English value was promoted to Case, the narrative document was not created for the local Case. | SAF-26415 |
| Fixed an issue where, when exporting an XML file with a blank F.r.3.2 (Test Result value / qualifier) and F.r.3.3 (Test Result unit), an empty tag was included in the XML file, which led to a failed import. | SAF-26754 |
March 10, 2022
Release Number: 21.3.0.12 | Build Number: 555
| Description | Issue No. |
|---|---|
| Fixed an issue where, when a Study Case was promoted, the Case Product name was not included in the name of the Case if there was no Study Product name. Now, if there is no Study Product name, the system includes the Primary Product name in the name of the Case, if it exists. | SAF-24312 |
| Fixed an issue where, when an FDA MedWatch 3500A form was generated, section B2 (Outcome Attributed to Adverse Event) only contained the primary Case Adverse Event Seriousness values and did not contain those for the non-primary Case Adverse Event. | SAF-26762 |
March 3, 2022
Release Number: 21.3.0.11 | Build Number: 547
| Description | Issue No. |
|---|---|
| Fixed an issue where, when a PADER Non-Primary Suspect Product Report was generated, an older Case version with a non-primary suspect product was included. | SAF-25207 |
| Fixed an issue with Date Received by Manufacturer (24c) field mapping when generating the CIOMS I form. Now, the New Info Date field will be used to populate Date Received by Manufacturer on the form for both Initial and Follow-Up Cases. | SAF-25679 |
| Fixed an issue where, when an FDA MedWatch 3500A form was generated, the UID/MFR Report # was not completely printed on the form for some cases. | SAF-26416 |
February 17, 2022
Release Number: 21.3.0.10 | Build Number: 518
| Description | Issue No. |
|---|---|
| Fixed an issue where a submission to the FDA containing Northern Ireland country code "XI" was rejected. Now, submissions to the FDA will use the country code "GB" for Northern Ireland whereas submissions to all other destinations will use the 2-character country code in Vault. | SAF-24493 |
| Fixed an issue where using Vault Loader to update Study Persons was unsuccessful if the First Name and Email fields were left blank. This is due to system-managed validation rules for the Person object which limit the number of characters and does not accept null fields. Now, First Name Length and Email Address Length validation rules can be edited. | SAF-24993 |
| Fixed an issue where, when any Inbox Item section or record was verified with no changes made, the old and new values on the audit trail still displayed all the fields. | SAF-25025 |
| Fixed an issue where inconsistent timezones were used to determine the date in generated forms. Now, CIOMS I and FDA 3500A reports will use Vault's default timezone. For E2B exports, users can convert the date to use the appropriate timezone. | SAF-25344 |
February 10, 2022
Release Number: 21.3.0.9 | Build Number: 498
| Description | Issue No. |
|---|---|
| Fixed an issue with E2B(R2) and E2B(R3) imported AERs where, when the AER contained a second serious Adverse Event (AE) or suspect product, a Case Assessment for this serious AE or product was not created upon Case promotion. | SAF-22864 |
| Fixed an issue where Localized Cases were moved to Closed state upon promoting them to a Follow-Up Case. | SAF-25154 |
| Fixed an issue where Reason Omitted (nullFlavor) values were incorrectly displayed for some FDA VAERS Regional fields. | SAF-25237 |
February 3, 2022
Release Number: 21.3.0.8 | Build Number: 482
| Description | Issue No. |
|---|---|
| Fixed an issue where, upon importing an Inbox Item from an E2B file or intake API call, the Inbox Item audit trail displayed the record ID for multiple fields instead of labels and names for picklist and object fields, respectively. | SAF-22865 |
| Fixed an issue where, when some Inbox Item sections were verified and saved, certain fields were logged in the Old Value and New Value columns on the audit trail. | SAF-24452 |
| Fixed an issue where, an additional blank Product record was created for a Localized Case upon Case promotion. | SAF-24628 |
| Fixed an issue where the system was not creating Case Assessment records for products linked with unknown (UNK) adverse event terms upon Case promotion of E2B-imported Inbox Items. | SAF-25006 |
| Fixed an issue where an Index Out of Bounds error appeared and the CIOMS I report failed to generate for a distribution. | SAF-25024 |
| Fixed an issue where the Meddra Version was not populated with "-" when importing an E2B file to AER with a blank MedDRA Version. This resulted in the E2B Import field being set to No. | SAF-25245 |
| Fixed an issue with E2B(R2) export where, when a distribution with Study Content Protection set to Mask Unblinded Content was created, the masked file contained susbtance information. | SAF-25502 |
January 27, 2022
Release Number: 21.3.0.7 | Build Number: 458
| Description | Issue No. |
|---|---|
| Fixed an issue where Case Product Substances were not snapshotted upon promoting an Inbox Item. | SAF-22484 |
| Fixed an issue where, when a user tried to verify the Awareness Details, a server error appeared due to duplicate entries existing for one field. This is a previous fixed issue (SAF-24406) from 21R3.0.3 with a newly implemented solution. Now, if a field is updated more than once, the value reflects the most recently entered data. | SAF-24535 |
| Fixed an issue where the CIOMS I file failed to generate due to a missing delimiter in the Case Assessment name. | SAF-24669 |
| Fixed an issue where the Inbox Item audit trail logged the unverified Product section as "Verified" instead of "Edited" when the Study was changed in the Details section. | SAF-24913 |
| Fixed an issue with PSUR reports where, when multiple Core Datasheets contained the same MedDRA term, the Expectedness was set using an incorrect or unrelated Core Datasheet. | SAF-24991 |
| Fixed an issue with E2B imported Inbox Items with Parent Information. When the Study field was set on the Inbox tab in list view, this resulted in only the Parent Case Study being updated upon Case promotion and not the Patient Case Study. | SAF-25180 |
| Fixed an issue where, when creating an Inbox Item from JSON Intake API, a data truncation error appeared and the Inbox Item was not created. | SAF-25426 |
January 20, 2022
Release Number: 21.3.0.6 | Build Number: 439
| Description | Issue No. |
|---|---|
| Fixed an issue with AERs where, when creating a Follow-Up Case from an E2B imported Study Case, a duplicate Study Registration record was created. | SAF-19687 |
| Fixed an issue with manual E2B multi-case import to Inbox Item where an inbound transmission record was created for the main E2B file when it should only be created when importing through an AS2 gateway. | SAF-23169 |
| Fixed an issue where custom dose units were not included in the generated DSUR List of Subjects Who Died During the Reporting Period table and the PBRER and DSUR Interval Line Listings of Serious Adverse Reactions tables. | SAF-23693 |
| Fixed an issue where each time the Inbox Item Details section was saved with no changes, the audit trail logged "Record saved with no changes". In addition, if the Study field was populated when saving the Details section, the audit trail logged changes from the Product section when there were none. | SAF-24327 |
| Fixed an issue with E2B imported Inbox Items where, after promoting to an Initial Case and, subsequently, to a Follow-Up Case, Case Assessment records were created for all concomitant medications. | SAF-24430 |
| Fixed an issue where the Case Product Dose Text on Inbox Items displayed a maximum length of 1500 characters when only 1499 characters were accepted for this field. Entering 1500 characters resulted in an error when trying to promote the Inbox Item to Case or save the section. | SAF-24466 |
| Fixed an issue with rule sets using the most conservative product where, when a submission with a fatal non-primary Case Adverse Event was evaluated, the 7-Day SUSAR (Death) and SUSAR (Life Threatening) rules were not triggered. | SAF-24709 |
January 13, 2022
Release Number: 21.3.0.5 | Build Number: 421
| Description | Issue No. |
|---|---|
| Fixed an issue with E2B(R2) and E2B(R3) import where the Event Country on the primary Case Adverse Event was left blank if the country code on the E2B file was in lower case. | SAF-16267 |
| Fixed an issue with CIOMS, FDA 3500A, E2B(R2), and E2B(R3) reports where, when the transmission document name exceeded the maximum length of 100 characters, the transmission document failed to generate. Now, if the transmission document name exceeds 100 characters, it will be truncated to allow for successful generation. | SAF-23315 |
| Fixed an issue with domestic case processing where a non-Vault Owner user was unable to save the localized text field if they only had Edit permissions for the localized field but not for the Session Store ID. | SAF-23442 |
| Fixed an issue where the Literature Reference(s) (A.2.2 or C.4.r.1) was only exported to E2B(R2) or E2B(R3) if the Retransmit field was set to Yes. Now, the Literature Reference(s) is exported regardless of whether the Retransmit field is set to Yes, No, or is left blank. | SAF-23590 |
| Fixed an issue with PSUR reports where, when the Product Family contained an odd number of drug products, some terms in the generated PSUR report for the Product Family were incorrectly marked as Expected. | SAF-23736 |
| Fixed an issue where the Source (text) and Method (text) field values were not displayed in the generated CIOMS file when Source Type and Method of Assessment were blank. | SAF-24290 |
| Fixed an issue where, when importing an E2B(R2) file with a MedDRA term but no corresponding MedDRA code to Inbox Item, the MedDRA version was appended to the reported text field after promoting to Case. This led to issues with auto-coding. | SAF-24408 |
| Fixed an issue for users who do not have access to Localized Cases in vaults with domestic case processing configured. After promoting an Inbox Item to a Global Case, the "You do not have permission to view details of this record" text and the English language tag were displayed for the Reporting Summary and Reporter's Comments fields on the Global Case. | SAF-24467 |
| Fixed an issue where, when importing an E2B(R2) file with a Literature description, a Literature placeholder and reference were not generated upon import. | SAF-24533 |
| Fixed an issue where, upon importing an E2B file with no agent and no date information (such as Receipt Date, New Info Date, Transmission Date, or Creation Date) through an AS2 gateway to Inbox Item or AER, the Receipt Date and New Info Date were incorrectly set. | SAF-24567 |
| Fixed an issue where the Age (normalized) field was rounded up instead of being truncated. | SAF-24609 |
| Fixed an issue where duplicate detection did not return any potential matches if Matching Contents contained special characters and operators, such as " ' ( ) *. Now, special characters and operators are treated as normal characters and do not impact duplicate detection. | SAF-24737 |
| Fixed an issue where a validation failure occurred for a Case due to the treatment drug being transmitted to EMA E2B(R3), FDA VAERS E2B(R3), and PMDA E2B(R3). | SAF-24804 |
| Fixed an issue with PBRER and DSUR Interval Line Listings of Serious Adverse Reactions where, when Indicate Unexpected Term was enabled, non-serious adverse events were added as serious adverse reactions in the generated table. | SAF-24868 |
January 4, 2022
Release Number: 21.3.0.4 | Build Number: 372
| Description | Issue No. |
|---|---|
| Fixed an issue where, in cases with merge fields using VQL tokens referring to multiple object levels, Vault failed to merge correctly. | DEV-454490 |
| Fixed an issue where, when the Re-evaluate Submission/Distribution action was run on a Case, a NullPointerException (NPE) error appeared if the country on the Expectedness record did not match the registration country. | SAF-22897 |
| Fixed an issue where system performance was slow when opening a Case due to the entire list of watchlist criteria being loaded instead of just the watchlist criteria for the Product. | SAF-24651 |
| Fixed an issue where, when a Case Product was created, it could not be saved if the dosage frequency was set to Other. | SAF-24781 |
December 16, 2021
Release Number: 21.3.0.3 | Build Number: 356
| Description | Issue No. |
|---|---|
| Fixed an issue with the PADER Summary of ADR from Postmarketing Sources report where, if the Case Assessment Expectedness was overridden, the adverse event was detected as both labeled and unlabeled in the generated report. | SAF-22903 |
| Fixed an issue where, if the domestic Case was regenerated after updating the Localization from a blank field to a non-Global value, the localized Case Contact, Case Adverse Event, and Case Product records were empty (not linked). | SAF-23090 |
| Fixed an issue with domestic Case processing where the localized Patient Contact was not generated for the Case after Case promotion. | SAF-23134 |
| Fixed an issue with domestic Case processing where the localized Patient Contact was not generated for the Case after Case promotion. | SAF-23134 |
| Fixed an issue where, when Indicate Unexpected Terms was enabled, the DSUR log sheet for Cumulative Summary Tabulation of Serious Adverse Reactions included unrelated Cases. The total number of events was not impacted in the tabulation. | SAF-23459 |
| Fixed an issue with PADER 15 Day and Non-15-Day Summary Reports and Interval Line Listings reports where the Case was counted as both labeled and unlabeled if the Case Expectedness was overridden and no longer matched the Primary Case Assessment Expectedness. | SAF-23581 |
| Fixed an issue where, when promoting a domestic Case to follow-up, some localized Case Contacts were not generated. | SAF-23646 |
| Fixed an issue where an error message did not appear when a user exceeded the maximum character limit for the Reporting Summary app control field. | SAF-23684 |
| Fixed an issue where a duplicate Patient record was created upon promoting an Inbox Item to a Follow-Up Case. | SAF-23794 |
| Fixed an issue when importing E2B to Inbox Item where, if the PV Agreement field was not set to Agent for the Origin Organization, C.1.4 (Date Report Was First Received from Source) and C.1.5 (Date of Most Recent Information for This Report) populated the Receipt Date/New Info Date field instead of C.1.2 (Date of Creation). | SAF-23822 |
| Fixed an issue where, upon promoting an Inbox Item with Event records with Medical History type, the name_reported__v field on the Case Medical History records was blank. | SAF-23899 |
| Fixed an issue with E2B(R2) imported Inbox Items where Patient RoA was only displayed in the source panel but not populated in the Product section field upon import. | SAF-24075 |
| Fixed an issue where an E2B imported Inbox Item could not be promoted to Case if it contained Medical History records. | SAF-24161 |
| Fixed an issue with domestic Case processing where, when an Inbox Item with Product Substances was promoted to Case, the localized Case was generated without child records. | SAF-24377 |
| Fixed an issue where, when a user tried to verify the Awareness Details, a server error appeared due to duplicate entries existing for one field. | SAF-24406 |