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 22R1 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 22R1.0, so our maintenance releases for this version are 22R1.0.1, 22R1.0.2, 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 22R1 Maintenance Releases.
Last Updated: December 9, 2022
July 28, 2022
Release Number: 22.1.0.12 | Build Number: 683
| Description | Issue No. |
|---|---|
| Fixed an issue where, when evaluating expectedness during cross reporting for Investigational to Marketing or Marketing to Marketing scenarios, Study Core Datasheets were considered incorrectly. This resulted in unnecessary Submissions being generated. | SAF-30237 |
| Fixed an issue where missing Clinical Trial Application (CTA) numbers in the Study Name data element (A.2.3.1) caused submissions to Health Canada to be rejected. | SAF-31025 |
| Fixed an issue where IND numbers were not populated on FDA MedWatch 3500A forms after report generation. | SAF-31756 |
EDQM Dictionary Updates
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated its standard terminology for the Dose Form and Routes of Administration (RoA) data elements on E2B(R3) Submissions. As a result, Vault Safety has implemented the following changes to its standard EDQM Mappings.
| New Record: | Updated Records: |
|---|---|
| CDF-13157000 |
|
July 21, 2022
Release Number: 22.1.0.11 | Build Number: 673
| Description | Issue No. |
|---|---|
| Fixed an issue where, if an E2B file included Parental Medical History or Parental Drug History details but did not include Parent Case information, the system prevented both importing the file as an Imported Case and promoting the imported Inbox Item to a Case. Now, upon initiating either action, the system creates the Parent Case for the associated child records. | SAF-29588 |
| Fixed an issue with creating Follow-up Cases where, when the original Case included an Assessment record with a value in a custom field, if the custom field did not appear on the Case Compare page, the value was not populated on the related Follow-Up Case Assessment record. | SAF-30122 |
| Fixed an issue where Follow-Up Rule questionnaire emails were not sent for a Case if any related Correspondence record did not include a Correspondence Document. | SAF-30769 |
| Fixed an issue where, when a Case included an Adverse Event with no value in the Primary field, the Interval Line Listing was not generated, preventing DSUR report creation. | SAF-30883 |
July 7, 2022 July 12, 2022
Release Number: 22.1.0.10 | Build Number: 659
| Description | Issue No. |
|---|---|
| Fixed an issue where the Investigational New Drug (IND) registration number was not populated on FDA MedWatch 3500A files when the Product Registration was not linked to a Study Product. Now, for Study Cases, the IND # field (G.5) is populated with the US IND number from the Study Registration. | SAF-29949 |
| Fixed an issue where, when importing an E2B(R2) file, the system created a Parental Case when no parent information was present. | SAF-29967 |
| Fixed an issue with generating FDA MedWatch 3500A files for imported Cases where, if the Name field on the Organization record is changed from "FDA" to "US FDA", "Foreign" is selected in the Report Source field (G.3) on the file even when the Case Primary Reporter Country is set to USA. | SAF-29968 |
| Fixed an issue with imported Cases where, if the Case included any partial dates (for example, YYYY) that were not populated in both the normalized and text Date fields, the system prevented the creation of a Follow-Up Case from the Case Compare page. | SAF-30185 |
Fixed an issue with generating EMA E2B(R3) files where the system was missing the following field validations:
|
SAF-30485 |
| Fixed an issue where, if Case Assessments for the non-primary product were deleted from a Case, the system prevented the creation of a Follow-Up Case. | SAF-30963 |
June 30, 2022
Release Number: 22.1.0.9 | Build Number: 624
| Description | Issue No. |
|---|---|
| Fixed an issue with imported Cases where the Case Assessment Record ID was exported to the Assessment Name field on CIOMS I forms. Now, the field will be populated with the Case Adverse Event Name and Product Name. | SAF-28784 |
| Fixed an issue with validating E2B(R3) files where the D.9.2.R.2 Reported Cause(s) of Death (free text) was required if D.9.2.R.1 Reported Cause(s) of Death was populated. Now, in accordance with EMA Business Rules, the field is always optional. | SAF-28917 |
Fixed the following issues with global (ICH) Validation Criteria objects:
|
SAF-28919 & SAF-29580 |
| Fixed an issue where, when importing an E2B file through a System Gateway, the system did not create Inbox Items, and instead created AERs. | SAF-29432 |
| Fixed an issue where, if a manual Inbox Item was saved and then edited to add a Source document, the Save button had to be selected twice to save the Inbox Item. | SAF-29772 |
| Fixed an issue where, when the Case Assessment Expectedness was blank on a Study Case, the system did not correctly evaluate the most conservative product and assessment. | SAF-29911 |
| Fixed an issue where, when the Re-evaluate Submission/Distribution action was run on a Case, a NullPointerException (NPE) error appeared if a Case Assessment record was not linked to an adverse event. | SAF-30478 |
June 20, 2022
Release Number: 22.1.0.8 | Build Number: 602
| Description | Issue No. |
|---|---|
|
Vault Safety now supports the generation of E2B(R2) formats with optimized backward-forwards compatibility logic. This export logic enhances support for global health authorities including Health Canada. Enablement: Auto-On Default Impact: Visible to All Users GxP Risk: High For more information, see ICH E2B(R2) Mapping. |
SAF-27572 |
| Fixed an issue where, when an Inbox Item was created from a non-E2B source file, the Origin field was blank after Case promotion. | SAF-28973 |
| Fixed an issue where the most conservative product selection was not limited to products defined within the Product Parameter. | SAF-29045 |
| Fixed an issue with EMA Submissions where the Transmission Lifecycle reverted to the "MDN Received" state after the "ACK Accepted", "ACK Rejected", or "ACK Warning" state. | SAF-29634 |
| Fixed an issue where, when merging an Inbox Item to a Follow-Up Case, Assessment Tags were not correct on the Case name, though they were correct on the Case. | SAF-29723 |
| Fixed an issue where, when the Case Assessment Expectedness was blank on a Study Case, the system did not correctly evaluate the most conservative product and assessment. | SAF-29911 |
|
Fixed an issue where, if a previous Transmission to a destination was Downgraded, the system did not correctly evaluate the One Last Time Reporting Rule. Enablement: This fix requires support enablement in 22R1.0.8, but will be auto-on in 22R2. |
SAF-29919 |
| Fixed an issue where, when an Inbox Item was created manually and then merged to an in-flight Case, an additional Narrative document was created on the updated Case. | SAF-30227 |
June 9, 2022
Release Number: 22.1.0.7 | Build Number: 575
| Description | Issue No. |
|---|---|
|
To support mandatory EDQM standard terminology for pharmaceutical dose forms and routes of administration when reporting to EudraVigilance, Vault Safety now supports mapping those fields to the latest EDQM terms when importing and exporting E2B files. Enablement: Admin Checkbox Default Impact: Visible to Admins Only GxP Risk: Medium For more information, see the EDQM Dose Form and Routes of Administration Terms on EMA Submissions FAQ. |
SAF-6915 |
| Fixed an issue on some Production Validation and Demo Vaults where the following Operations Jobs were inactive: Reporting Notification for Followup and Safety Daily Maintenance. | SAF-29188 |
| Fixed an issue where, when importing an E2B file, the Patient RoA was incorrect on the Inbox Item. | SAF-29527 |
June 2, 2022
Release Number: 22.1.0.6 | Build Number: 546
| Description | Issue No. |
|---|---|
| Fixed an issue where, when creating a localized Follow-Up Case, the child and grandchild records were moved to the Closed state. | SAF-27870 |
Fixed an issue with migrated Cases where the country was not populated on CIOMS I or FDA 3500A forms after report generation. Now, the fields will be populated as follows:
|
SAF-28781 |
| Fixed an issue where expectedness was not evaluated correctly when cross reporting to a study for the same product. | SAF-28890 |
| Fixed an issue where, when a Case was missing a UID, the List of Subjects Who Died During the Reporting Period was not generated, preventing DSUR report creation. | SAF-29033 |
| Fixed an issue where, after importing an Inbox Item from a non-E2B source document, if you manually changed the New Info Date on the Inbox Item, the Receipt Date was being populated incorrectly upon Case promotion. | SAF-29301 |
May 26, 2022
Release Number: 22.1.0.5 | Build Number: 526
| Description | Issue No. |
|---|---|
| Fixed an issue where, when the Evaluate Reporting Obligations action was run on a Case with a product registered in multiple countries, the exported E2B files incorrectly included the country-specific registration details entered on the Case Product for all countries instead of just the registration in the target jurisdiction. | SAF-27877 |
Fixed an issue with generating E2B(R3) files where the system was missing the following field validations:
|
SAF-28032 & SAF-28218 |
| Fixed an issue where a term in the Vault Safety Designated Medical Events (DME) Watchlist did not match the EMA DME. The term Immune thrombocytopenia (10083842)* was added. | SAF-28217 |
| Fixed an issue where, 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 were set to version 2.2, instead of 2.1. | SAF-28256 |
| Fixed an issue where Medical History & Concurrent Conditions records were being compared during duplicate detection, though they should not be. | SAF-28297 |
| Fixed an issue where, when a Case Test Result (Text) field had more than 18 characters, all subsequent field characters were replaced with zeroes on CIOMS I and FDA 3500A forms. | SAF-28354 |
Fixed an issue where the Age and Weight fields were not populated on the CIOMS I form after report generation if the following setup was present on the Case:
Now, if the Age (normalized) or Weight (normalized) fields are blank, the Age or Weight value and unit (if present) are exported and set on the CIOMS I form. |
SAF-28482 |
| Fixed an issue where, on the NMPA Report Source Controlled Vocabulary type, editing the Name field was prevented by the system. | SAF-28619 |
| Fixed an issue where, when creating an Inbox Item, if a mixture of precise dates (for example, YYYY/MM/DD) and partial dates (for example, YYYY) was used for specific field combinations, and those dates included the same year, the system prevented Inbox Item creation. | SAF-28723 |
| Fixed an issue where, when importing an E2B(R3) file, if the Date of Birth was a partial date (for example, YYYY), the Date of Birth field was blank on the Inbox Item. | SAF-28779 |
| Fixed an issue where, when the Sender's Organisation field included more than 60 characters, a system error prevented the Evaluate Reporting Obligations action from running for PMDA E2B(R3) reports. | SAF-28951 |
| Fixed an issue where, when a Case Test Result value and unit were blank, the system prepended a zero to Case Test Result (Text) fields on CIOMS I and FDA 3500A forms. | SAF-29165 |
May 19, 2022
Release Number: 22.1.0.4 | Build Number: 502
| Description | Issue No. |
|---|---|
Fixed an issue with Date Received by Manufacturer (Section G4) field mapping when generating FDA MedWatch 3500A forms. Now, the Case New Info Date field (if populated) will be used for the Date Received by Manufacturer on the form for both Initial and Follow-Up Cases. If the New Info Date field is blank, the field on the form will be populated as follows:
|
SAF-26026 |
Fixed an issue where, when importing an E2B(R2) file, if the Suspect or Interacting products were not listed first, the following fields were not mapped to the Case Assessment correctly:
|
SAF-27458 |
| Fixed an issue where, when an Adverse Event Report was created from a non-E2B source file with a date in the Receipt Date field, the date was not applied to the New Info Date field on the Inbox Item. | SAF-27863 |
| Fixed an issue where Case Contacts assigned Rank 1 were always being compared as Reporter-type Case Contacts during duplicate detection, even when the "Contact is also Reporter" checkbox was not selected. | SAF-28328 |
Fixed an issue where the Age and Weight fields were not populated on the CIOMS I form after report generation if the following setup was present on the Case:
Now, if the Age (normalized) or Weight (normalized) fields are blank, the Age or Weight value and unit (if present) are exported and set on the CIOMS I form. |
SAF-28482 |
| Fixed an issue where, when the “AE in Jurisdiction” rule parameter on a rule set was set to No, Vault Safety did not apply the Agency Rule. | SAF-28534 |
| Fixed an issue where the Weight field was not populated on FDA MedWatch 3500A forms after report generation if only Weight (normalized) was present. Now, if the Weight value and unit are blank on the Case, the Weight (normalized) field (if present) will be exported and set as the Weight on the FDA 3500A form. | SAF-28687 |
| Fixed an issue with migrated Cases where if either the Normal Low Value or Normal High Value fields were blank, the normal range for the test was not populated on CIOMS I or FDA 3500A forms after report generation. Now, if one field is blank, the missing part of the range is populated as "Unknown". If neither the Normal Low Value nor the Normal High Value is populated on the Case, the normal range for the test is not included on generated reports. | SAF-28782 |
May 10, 2022
Release Number: 22.1.0.3 | Build Number: 460
| Description | Issue No. |
|---|---|
| Fixed an issue where, when a Follow-Up Case was created from a global Case using the Create Follow-Up Case user action, the Localized Follow-Up Case link was not populated on the localized Narrative document. | SAF-26917 |
| Fixed an issue with global Case processing where, when trying to update the rank of a Product with a Substance to a Product without a Substance, an error appeared if the Product with a Substance was on a linked Localized Case. | SAF-27681 |
| Fixed an issue where, when Cases were imported using migration user, the Imported Cases were not automatically indexed for duplicate case detection. | SAF-27780 |
| Fixed an issue where, when a localized Follow-Up Case was created, the child and grandchild records were moved to the Closed state instead of the Active state. | SAF-27870 |
| Fixed an issue where, when E2B-imported Inbox Items were promoted, incorrect values appeared in the Source Type field on Case Assessment Results. | SAF-27871 |
| Fixed an issue where, when an E2B(R2) file that included multiple Adverse Events with the same MedDRA code was imported, the Case Assessment records were not imported correctly. | SAF-27954 |
| Fixed an issue where an incorrect error message appeared when creating a Follow-Up Case if there was an existing invalid Follow-Up Case for that Case. | SAF-27978 |
| Fixed an issue where, when a Case was locked, the system prevented SDK jobs from updating the Case and its child records. | SAF-28203 |
| Fixed an issue where, for imported Inbox Items, expanding and then collapsing the Case Contact section caused a blank page to appear. | SAF-28465 |
| Fixed an issue where E2B(R3) Transmissions were not generated when the Blind Protection Relatedness Override - CIOMS I and E2B feature was enabled. This issue affected all E2B(R3) transmissions. | SAF-28536 |
May 5, 2022
Release Number: 22.1.0.2 | Build Number: 439
| Description | Issue No. |
|---|---|
| Fixed an issue where users might have experienced data integrity issues when updating documents. | DEV-486987 |