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 22R2 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 22R2.0, so our maintenance releases for this version are 22R2.0.2, 22R2.0.3, 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 22R2 Maintenance Releases.
Last Updated: May 17, 2023
December 1, 2022
Release Number: 22.2.0.29 | Build Number: 829
| Description | Issue No. |
|---|---|
| Fixed an issue where, when a migrated Case did not have a Dose Frequency value but had a Dose Frequency time interval, the system prevented creating a Follow-Up Case. | SAF-36028 |
November 17, 2022
Release Number: 22.2.0.28 | Build Number: 825
| Description | Issue No. |
|---|---|
|
Fixed an issue where, in some instances after Case promotion, the Inbox Item was missing the link to the Case. Affected customers have been notified of the issue and resolution. Enablement: Support |
SAF-34790 |
| Fixed an issue where, when an Inbox Item was edited after saving the Product and Dosage, the Dose Form Text and Patient RoA Text fields were populated with IDs instead of the text values on the Inbox Item. This issue affected the Case Compare page and the new or Follow-Up Case Product Dosage record. | SAF-35060 |
| Fixed an issue where, if two different Case Products referenced the same Study Product, the system prevented unblinding Cases and creating a Follow-up Case from a Closed Case. | SAF-35126 |
| Fixed an issue with E2B report generation where, when the Retransmit field was set to No, the Related Case Identifier was exported to the A.1.12 or C.1.10.r (Identification Number of the Report Which Is Linked to This Report) data element, resulting in Negative Acknowledgement (NACK) messages. | SAF-35735 |
November 10, 2022
Release Number: 22.2.0.27 | Build Number: 818
| Description | Issue No. |
|---|---|
| Fixed an issue where, when performing a Case Compare, if a Reporter Type was merged in as a Patient Type and the Primary Source field was selected to be kept, the merge failed because the Primary Source field does not exist for a Patient Type. Now, merging across Object Types is prevented by the system. | SAF-31436 |
| Fixed an issue where, when a non-serious adverse event was added to a Case and replaced another non-serious adverse event as primary, Case Assessments were not updated. | SAF-31894 |
| Fixed an issue where clinical trial cross reporting scenarios were evaluated on Studies with Unspecified Products when the Study Case Type was set to "Clinical Trial" or blank. | SAF-33822 |
| Fixed an issue where system performance was slow when generating CIOMS I forms. | SAF-34494 |
| Fixed an issue where email distributions were sent when the system completed rendering of an email cover letter, instead of when the Send Email Transmission action was initiated. | SAF-34531 |
| Fixed an issue where, when a Transmission Profile was set to include additional output formats and an email cover letter, the email recipient received separate emails for each Transmission document, instead of one email with all of the Transmission documents. | SAF-34675 |
| Fixed an issue where, when the Submit to Gateway and the Evaluate Submission Obligations actions were executed in close succession, a NullPointerException (NPE) error appeared and the Submit to Gateway action did not complete. | SAF-34677 |
| Fixed an issue where, if a Case included any Product with no associated Case Assessments, the system automatically considered the primary product and assessment as the most conservative. Now, the system queries all Case Products with Case Assessments to identify the most conservative product and assessment. | SAF-34736 |
| Fixed an issue where, when an E2B(R2) file included assessments that were not linked to an adverse event, Case import failed. | SAF-34957 |
| Fixed an issue where, when a Localized Case was reportable to an Agency without a Localization setting, case validations failed to run and a NullPointerException (NPE) error message was displayed. | SAF-35003 |
| Fixed an issue where, when generating Health Canada E2B(R2) files for a Localized Case, the global product and substance names were exported. Now, the information entered in the Product (Reported) field on the Localized Case Product will populate the B.4.k.2.1 data element, and the information entered in the Name (Reported) field on the Localized Case Product Substance will populate the B.4.k.2.2 data element. | SAF-35028 |
|
Fixed an issue where, when the system recalculated expectedness during cross reporting, the most conservative product and assessment evaluations were incorrect. Enablement: Support |
SAF-35093 |
| Fixed an issue where, when a Case included large amounts of data, the system was slow when calculating the most conservative product while running validations. | SAF-35101 |
| Fixed an issue where comparators were not considered investigational medicinal products for cross reporting. | SAF-35221 |
| Fixed an issue where, when an Inbox Item included more than 500 grandchild records, Follow-Up Case creation failed. | SAF-35226 |
| Fixed an issue where, if an Inbox Item was created and then the active MedDRA version for the system was updated, after Case promotion, the previous MedDRA version still appeared on the Case. | SAF-35516 |
November 3, 2022
Release Number: 22.2.0.26 | Build Number: 790
| Description | Issue No. |
|---|---|
| Fixed an issue with FDA MedWatch 3500A generation where the G6. If IND/PreANDA, Give Protocol # field was populated although the G5. IND # field was blank. | SAF-31701 |
| Fixed an issue with E2B report generation where the system did not count decimal places in character counts, resulting in Negative Acknowledgement (NACK) messages when calculated fields exceeded E2B limits. Now, decimal places are included in character counts when generating E2B reports. | SAF-31788 |
| Fixed an issue with Case Promotion where, when copying patient information from an existing Case into a new Case, a system error occurred if Suspect/Interacting Products were selected to be copied. | SAF-32924 |
| Fixed an issue where, when the Localization field was set to Global, after Case promotion the value in the Case Product Indication (Reported) field was missing on the Case. | SAF-33006 |
| Fixed an issue where, when an Inbox Item for a Study was created from a non-E2B source file, after Case Promotion, the Case Products for the selected Study and Study Arm were not populated on the Case. | SAF-34068 |
| Fixed an issue where system performance was slow when generating CIOMS I forms. | SAF-34494 |
|
Fixed an issue where, when more than one MedDRA LLT record had the same MedDRA Version and had the Primary SOC field set to Yes, the incorrect MedDRA version was populated on Cases. Enablement: Support |
SAF-34651 |
| Fixed an issue where queries on Controlled Vocabularies may have caused performance issues when loading pages. | SAF-34747 |
| Fixed an issue where, when a Case included large amounts of data, the system was slow when generating E2B(R3) files. | SAF-34958 |
| Fixed an issue where blinded studies were not supported for the standalone CIOMS II line listing report. Additionally, if an administrator has configured Study Product placeholder names for a blinded Study, the CIOMS II report will now populate the placeholder name instead of the generic "Blinded" label. | SAF-34978 |
October 28, 2022
Release Number: 22.2.0.25 | Build Number: 768
| Description | Issue No. |
|---|---|
| Fixed an issue where bulk unblinding all Cases under a Study was prevented when one or more Cases was locked. | SAF-33197 |
|
Fixed an issue where, when custom reporting rules existed, the system did not correctly evaluate the most conservative product and assessment on Cases with multiple products and assessments. Enablement: Support |
SAF-34620 |
| Fixed an issue where system performance was slow when generating E2B(R2) files. | SAF-34787 |
| Fixed an issue where, when a Domestic Case had the Localization field set to Global, the system did not run the rules engine nor validations, and did not assign a Due Date to the Case. | SAF-35103 |
October 25, 2022
Release Number: 22.2.0.24 | Build Number: 755
| Description | Issue No. |
|---|---|
| Fixed an issue where system performance was slow when calculating and assigning watchlist tags. | SAF-32716 |
| Fixed an issue where system performance was slow when running the Evaluate Regulatory Obligations action on a Case with a large number of cross reporting scenarios. | SAF-33749 |
| Fixed an issue where system performance was slow during E2B import. | SAF-34498 |
| Fixed an issue where, when strict case locking was enabled, in some Cases merge to Follow-Up could not be completed. | SAF-34503 |
| Fixed an issue where system performance was slow when running the reporting rules engine. | SAF-34559 & SAF-34131 |
| Fixed an issue where system performance was slow when running the Evaluate Regulatory Obligations action. | SAF-34697 |
| Fixed an issue where, when errors occurred during Case promotion, system error messages did not describe the cause of the issue. | SAF-34701 |
| Fixed an issue where, when a global and Localized Case had a different number of Case Assessments, creating new Case Adverse Events was prevented. | SAF-34850 & SAF-34900 |
October 21, 2022
Release Number: 22.2.0.23 | Build Number: 734
| Description | Issue No. |
|---|---|
| Fixed an issue where, when merging new information into an in-flight Case, if the Inbox Item included a new primary Product, Adverse Event, or Case Contact, instead of updating the Case with the new primary object, the Case included two primary Products, Adverse Events, or Case Contacts. | SAF-32969 |
| Fixed an issue where, when promoting an Inbox Item to a Case, the audit trail did not record the result from the Potential Matches page for any actions other than marking the Inbox Item as a Duplicate. | SAF-33339 |
| Fixed an issue where, when an Inbox Item for a Study was created from a non-E2B source file, after Case Promotion, the Case Products for the selected Study and Study Arm were not populated on the Case. | SAF-34068 |
| Fixed an issue where, when a Case was Closed, saving edits on Transmissions and Transmission Messages was prevented. | SAF-34468 |
| Fixed an issue where, when a Case included large amounts of data, the system was slow when running validations. | SAF-34487 |
| Fixed an issue where, when strict case locking was enabled, merge to Follow-Up could not be completed for Cases with Combination Products. | SAF-34503 |
| Fixed an issue where system performance was slow when loading Case Product Details. | SAF-34507 |
| Fixed an issue where system performance was slow during auto-calculations. | SAF-34624 |
| Fixed an issue where, when errors occurred during Case promotion, system error messages did not describe the cause of the issue. | SAF-34701 |
October 18, 2022
Release Number: 22.2.0.22 | Build Number: 709
| Description | Issue No. |
|---|---|
| Fixed an issue where, when strict case locking was enabled, a Parent Information Case could be created but not edited. | SAF-31823 |
| Fixed an issue where, when typing Case data into an app control field, there was a lag before the value appeared in the field. | SAF-32089 |
| Fixed an issue with E2B-import where, when a Study Case included a Product with a Drug Role of Concomitant, Follow-Up Case creation failed because the system set the Primary field to No. | SAF-33283 |
| Fixed an issue where, when generating FDA MedWatch 3500A forms for Study Cases with Combination Products, the G5. Combination Product checkbox was not selected. | SAF-33313 |
| Fixed an issue where, in some instances, a system error occurred when generating custom E2B formats. | SAF-33834 & SAF-34074 |
| Fixed an issue where, when an Inbox Item included more than two reported terms that did not map to LLT MedDRA terms, automated Case promotion failed. | SAF-33910 |
| Fixed an issue where, if a Study Number was changed after the creation of a Study Case, Follow-Up Case creation was prevented on the Case Compare page. | SAF-34275 |
| Fixed an issue where, in some cases, Vault Safety ran redundant queries on Controlled Vocabularies, which may have caused performance issues for users. | SAF-34508 |
October 14, 2022
Release Number: 22.2.0.21 | Build Number: 697
| Description | Issue No. |
|---|---|
| Fixed an issue where, when importing an E2B(R2) file, the Test Name (LLT) field was not populated with the MedDRA-coded term. | SAF-31133 |
| Fixed an issue where, when strict case locking was enabled, a Parent Information Case could be created but not edited. | SAF-31823 |
| Fixed an issue where, when generating FDA MedWatch 3500A forms for Study Cases with Combination Products, the G5. Combination Product checkbox was not selected. | SAF-33313 |
| Fixed an issue where system performance was slow when running the Evaluate Regulatory Obligations action on a Case with a large number of cross reporting scenarios. | SAF-33749 |
| Fixed an issue where, when errors occurred during E2B import from an API Transmission, system error messages did not describe the cause of the issue. | SAF-33919 |
| Fixed an issue where, when importing an E2B(R2) file with a Safety Report Version that had more than two characters, the lifecycle state remained as "Importing" regardless of whether the import was complete or the Inbox Item could not be created. | SAF-34040 |
| Fixed an issue where, when a Case included large amounts of data, the system was slow when running validations. | SAF-34146 |
| Fixed an issue where, after generating Transmissions on a global Case, system performance was slow during Foreign Localized Case creation. | SAF-34237 |
| Fixed an issue where, in some cases, Vault Safety ran redundant queries, which may have caused performance issues for users. | SAF-34345 |
| Fixed an issue where, when sending multiple Email Transmissions for a Case, if at least one of the Transmission Profiles was set to include Additional Output Formats, all Transmission documents were included in every Email Transmission. | SAF-34480 |
| Fixed an issue where, when promoting an Inbox Item to a Follow-Up Case, a system error occurred if the original Case had duplicate Case Assessments for an adverse event and product pair. Now, the system prevents the creation of more than one Case Assessment for an adverse event and product pair. | SAF-34586 |
| Fixed an issue where, when an Inbox Item was promoted as a Follow-Up Case to a Case created from an E2B import, the Inbox Item Case field did not include a link to the Follow-Up Case and the Linked to field was populated with "EMPTY". | SAF-34629 |
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 change to its standard EDQM Mappings.
| New Records: | Updated Record: |
|---|---|
| N/A | PDF-50052000 |
October 12, 2022
Release Number: 22.2.0.20 | Build Number: 666
| Description | Issue No. |
|---|---|
| Fixed an issue where users may have experienced performance issues when sending notifications with tokens to many users. | DEV-521784 |
| Fixed an issue where users may have experienced poor performance when viewing the Home tab. | DEV-524809 |
|
Fixed an issue where, when generating E2B reports, a number of elements that the EMA does not accept as masked, such as Date of Death (D.9.1), were masked. This was causing EMA Submissions with one or more of these fields to be rejected. Enablement: Support |
SAF-30486 |
| Fixed an issue where, when promoting an Inbox Item to a Follow-Up Case, if the original Case had duplicate Case Assessments for an adverse event and product pair, a system error occurred. Now, the system prevents the creation of more than one Case Assessment for an adverse event and product pair. | SAF-31182 |
| Fixed an issue where system performance was slow when creating Follow-Up Cases. | SAF-32041 |
| Fixed an issue with the CSV rendition of imported E2B(R2) files where the B.4.k.18.1b Reaction(s) / Event(s) Assessed data element was populated with system-generated IDs, instead of the Adverse Event name. | SAF-32272 |
| Fixed an issue where, when errors occurred during initial and Follow-Up Case creation, system error messages did not describe the cause of the issue. | SAF-33196 |
| Fixed an issue where, when a Localized Case did not have a Transmission, the system prevented Transmission generation for the associated global Follow-Up Case. | SAF-33831 |
| Fixed an issue where, when errors occurred during E2B import from an API Transmission, system error messages did not describe the cause of the issue. | SAF-33919 |
| Fixed an issue where, when importing an E2B(R2) file with a Safety Report Version that had more than two characters, the lifecycle state remained as "Importing" regardless of whether the import was complete or the Inbox Item could not be created. | SAF-34040 |
| Fixed an issue where there were too many Vault notification emails being sent for successful completion of certain jobs. Users will continue to receive notifications in the application. | SAF-34177 & DEV-525436 |
October 7, 2022
Release Number: 22.2.0.19 | Build Number: 632
This release affects all PODs. In this release, fixes included in 22R2.0.18 are also included for PODs VLT-1142, VLT-1150, VLT-1157, VLT-2063, VLT-2075, and VLT-3120.
| Description | Issue No. |
|---|---|
| Fixed an issue where editing units of measurement caused system issues. | SAF-33653 |
| Fixed an issue where email cover letters were sent with merge field tokens, instead of the appropriate field values. | SAF-33738 |
| Fixed an issue where, when a Case Transmission Profile was blank, during the Void Case user action the system displayed an error message and did not generate Transmission records for all previously submitted destinations. | SAF-33774 |
| Fixed an issue where, when strict case locking was enabled, Follow-Up Cases could not be created if the Seriousness on the Case Adverse Event did not match the Inbox Item. | SAF-33807 |
|
Vault Safety can now import narratives from the bulk import narrative API endpoint directly to the document archive if Document Archive is turned on in the Vault. This is to support better search performance when migrating in a large set of cases. Enablement: Support |
SAF-33887 |
| Fixed an issue with the Receive E2B API endpoint where the response returned a status of 400 (failure) when the request was accepted but certain issues occurred or the E2B import was still in progress. | SAF-33911 |
| Fixed an issue where system performance was slow in certain circumstances while processing a Study Case. | SAF-33917 |
| Fixed an issue where, when a Localized Case did not include a localized Narrative document, Follow-Up Cases could not be created. | SAF-34078 |
| Fixed an issue where system performance was slow during Case processing. | SAF-34105 |
| Fixed an issue where system performance was slow when running the Evaluate Regulatory Obligations action. | SAF-34144 |
| Fixed an issue with E2B(R3) import where, if the D.7.1.r.5 Comments data element included more than 1,500 characters, the import failed. | SAF-34321 |
October 6, 2022
Release Number: 22.2.0.18 | Build Number: 613
This release only affects POD VLT-1067.
| Description | Issue No. |
|---|---|
| Fixed an issue with PADER 15 Day and Non-15-Day Summary Reports and Interval Line Listings where some Cases were omitted although they met the report settings. | SAF-34278 |
October 5, 2022
Release Number: 22.2.0.17 | Build Number: 600
This release only affects POD VLT-1067. This release only affects internal logging and contains no customer-facing fixes.
October 4, 2022
Release Number: 22.2.0.16 | Build Number: 593
| Description | Issue No. |
|---|---|
| Fixed an issue where, when generating E2B reports, a number of elements that the EMA does not accept as masked, such as Date of Death (D.9.1), were masked. This was causing EMA Submissions with one or more of these fields to be rejected. | SAF-30486 |
| Fixed an issue where, in cases involving certain VQL queries, users may have experienced slow performance. | DEV-521587 |
| Fixed an issue where, in some cases, Vault ran redundant queries on records, which may have caused performance issues for users. | DEV-522122 & DEV-521950 |
| Fixed an issue where, in some cases, users may have experienced performance issues when Vault was decrypting standard fields. | DEV-523568 |
October 2, 2022
Release Number: 22.2.0.15 | Build Number: 585
| Description | Issue No. |
|---|---|
| Fixed an issue where running SDK jobs caused system issues. | SAF-34033 |
| Fixed an issue where running the Evaluate Regulatory Obligations action caused system issues. | SAF-34116 |
| Fixed an issue where, when running the Evaluate Regulatory Obligations action for FDA Cross Reporting, validations failed when the most conservative Case Product was blank. | SAF-34124 |
September 30, 2022
Release Number: 22.2.0.14 | Build Number: 583
This release affects all PODs. In this release, fixes included in 22R2.0.13 are also included for PODs VLT-1142 and VLT-1150.
| Description | Issue No. |
|---|---|
|
Fixed an issue with Workflows that prevented expanding a Follow-Up Case Workflow Timeline and assigning tasks to users. Enablement: Support |
SAF-33453 |
| Fixed an issue where system performance was slow when creating Follow-Up Cases. | SAF-33670 |
| Fixed an issue where generating Transmissions caused system issues. | SAF-34025 |
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 change to its standard EDQM Mappings.
| New Record: | Updated Records: |
|---|---|
| PDF-13162000 | N/A |
September 29, 2022
Release Number: 22.2.0.13 | Build Number: 575
This release only affects PODs VLT-1067, VLT-1157, VLT-2063, VLT-2075, and VLT-3120.
| Description | Issue No. |
|---|---|
| Fixed an issue where users may have experienced performance issues on pages with many object controls. | DEV-520953 |
| Fixed an issue where users may have experienced performance issues when accessing the record action menu and action bar. | DEV-521493 |
| Fixed an issue where, when importing an E2B(R3) file with a Clinical Trial Case through a System Gateway, the C.5.2 (Study Name) and C.5.1.r.1/C.5.1.r.2 (Study Registration Number/Study Registration Country) had to match for the system to generate the Transmission Acknowledgement Code "AA" (E2B Import Success). Now, if the Study Registration values do not match the Study Name, the system matches by C.5.3 (Sponsor Study Number) when generating the Transmission Acknowledgement Code. | SAF-31183 |
|
Fixed an issue with Workflows that prevented expanding a Follow-Up Case Workflow Timeline and assigning tasks to users. Enablement: Support |
SAF-33453 |
| Fixed an issue where, when manually creating an Inbox Item, if the New Info Date and Report Type fields were populated before the Organization field, a system error occurred, preventing Inbox Item creation. | SAF-33518 |
| Fixed an issue where, after successful email delivery of a Transmission, the Email Transmission State did not update from "Ready" to "Completed". | SAF-33590 |
| Fixed an issue where system performance was slow when exporting E2B reports. | SAF-33661 |
| Fixed an issue where system performance was slow when creating Follow-Up Cases. | SAF-33670 |
| Fixed an issue where email cover letters were sent with merge field tokens, instead of the appropriate field values. | SAF-33738 |
| Fixed an issue causing performance issues when loading Case details. | SAF-33778 |
| Fixed an issue with E2B(R2) import where, if B.4.k.2.1 (Medicinal Product Name as Reported by the Primary Source) was blank and B.4.k.2.2 (Substance / Specified Substance Name) included more than 250 characters across all Substance names, the import failed. Now, if B.4.k.2.1 is blank, the system maps the first Substance in B.4.k.2.2, based on alphabetical order, to the Product (Reported) field on the Case Product object. | SAF-33802 |
| Fixed an issue where generating Transmissions caused system issues. | SAF-34025 |
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 change to its standard EDQM Mappings.
September 28, 2022
Release Number: 22.2.0.12 | Build Number: 575
The 22.2.0.12 maintenance release has been reverted due to a defect.
| Description | Issue No. |
|---|---|
| Fixed an issue where, when importing an E2B(R3) file with a Clinical Trial Case through a System Gateway, the C.5.2 (Study Name) and C.5.1.r.1/C.5.1.r.2 (Study Registration Number/Study Registration Country) had to match for the system to generate the Transmission Acknowledgement Code "AA" (E2B Import Success). Now, if the Study Registration values do not match the Study Name, the system matches by C.5.3 (Sponsor Study Number) when generating the Transmission Acknowledgement Code. | SAF-31183 |
|
Fixed an issue with Workflows that prevented expanding a Follow-Up Case Workflow Timeline and assigning tasks to users. Enablement: Support |
SAF-33453 |
| Fixed an issue where, when manually creating an Inbox Item, if the New Info Date and Report Type fields were populated before the Organization field, a system error occurred, preventing Inbox Item creation. | SAF-33518 |
| Fixed an issue where, after successful email delivery of a Transmission, the Email Transmission State did not update from "Ready" to "Completed". | SAF-33590 |
| Fixed an issue where system performance was slow when exporting E2B reports. | SAF-33661 |
| Fixed an issue causing performance issues when loading Case details. | SAF-33778 |
| Fixed an issue with E2B(R2) import where, if B.4.k.2.1 (Medicinal Product Name as Reported by the Primary Source) was blank and B.4.k.2.2 (Substance / Specified Substance Name) included more than 250 characters across all Substance names, the import failed. Now, if B.4.k.2.1 is blank, the system maps the first Substance in B.4.k.2.2, based on alphabetical order, to the Product (Reported) field on the Case Product object. | SAF-33802 |
September 23, 2022
Release Number: 22.2.0.10 | Build Number: 543
| Description | Issue No. |
|---|---|
| Fixed an issue where, when promoting an E2B-imported Inbox Item with a Combination Product to a Domestic Case, a system error occurred and the Domestic Case was not created if a Constituent Product included a Substance. | SAF-33589 |
| Fixed an issue where case promotion failed when attempting to create a Follow-Up Case from an E2B-imported Inbox Item containing a case assessment linking a product with an empty adverse event. | SAF-33700 |
| Fixed an issue causing performance issues when loading a Case.*This fix has been moved to the 22.2.0.11 release This fix has been moved to the 22.2.0.11 release | SAF-33737 |
September 22, 2022
Release Number: 22.2.0.9 | Build Number: 538
| Description | Issue No. |
|---|---|
| Fixed an issue where certain E2B transmission ACKs were being treated as warnings instead of errors. | SAF-30513 |
September 21, 2022
Release Number: 22.2.0.8 | Build Number: 537
This release only affects POD VV1-1150 and only affects internal infrastructure.
There are no customer-facing fixes in this release.
September 20, 2022
Release Number: 22.2.0.7 | Build Number: 536
| Description | Issue No. |
|---|---|
| Fixed an issue causing performance issues while viewing the narrative preview on a Case. | SAF-33669 |
| Fixed an issue where running the Evaluate Regulatory Obligations action caused system issues. | SAF-33622 |
| Fixed an issue where, when a large number of users loaded pages at once, system issues occurred. | SAF-33623 & SAF-33631 |
September 11, 2022
Release Number: 22.2.0.6 | Build Number: 509
| Description | Issue No. |
|---|---|
| Fixed an issue where system performance was slow when auto-coding and saving MedDRA terms. | SAF-33215 & SAF-33237 |
September 8, 2022
Release Number: 22.2.0.5 | Build Number: 504
| Description | Issue No. |
|---|---|
| Fixed an issue where, when Cross Reporting Most Conservative Submission was enabled, system performance was slow when the Evaluate Reporting Obligations action was run on a Case. | SAF-33122 |
| Fixed an issue where, when the Reporter Country was edited on an Inbox Item, the Localization field was not updated. This resulted in the incorrect Localization being applied to the Case after promotion. | SAF-33146 |
| Fixed an issue where, when an Inbox Item for a Domestic Postmarket Case included a Combination Product, a Localized Case was not generated after Case promotion. | SAF-33148 |
| Fixed an issue where, when a Combination Product was added to a Study Case, the Product Type for Device constituents was "Study Product", instead of "Device", and the Product Name did not appear correctly. | SAF-33154 |
September 4, 2022
Release Number: 22.2.0.4 | Build Number: 488
| Description | Issue No. |
|---|---|
Fixed an issue where, when strict case locking was enabled, the following actions did not complete on unlocked Cases and the system did not provide an error message:
|
SAF-32889 |
| Fixed an issue with Case Type-based localization where, when the "Domestic Case Processing and Submission: Report Type-Based Localization" feature was enabled, the system did not consider a Localization's Case Type setting when generating foreign Localized Cases for Submissions. | SAF-32940 |
| Fixed an issue where, when generating a Localized Narrative for a foreign Localized Case, the system linked it as a Supporting Document to the Global Narrative. | SAF-32940 |
| Fixed an issue where, when generating an FDA E2B(R2) report for a Study Case with a Combination Study Product, < drug > blocks were not exported. | SAF-33104 |
September 1, 2022
Release Number: 22.2.0.3 | Build Number: 479
| Description | Issue No. |
|---|---|
| Fixed an issue where system performance was slow during the Submit to Gateway action. | SAF-30075 |
Fixed an issue where some units of measure in the Unified Code of Units of Measure (UCUM) dictionary were not supported on E2B(R2) export. Now, values are exported in E2B(R2) files, with overflow support for some data element limits as follows:
|
SAF-31085 |
| Fixed an issue with E2B(R3) export logic for Domestic Cases, which resulted in the Localized Narrative being included in the H.1 (Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information) data element, as well as the H.5.r.1a (Case Summary and Reporter's Comments Text) data element. Now, the Localized Narrative is exported only to the H.5.r.1a data element. | SAF-31689 |
| Fixed an issue where, when there was a non-English Localization specified on the Inbox Item, after Case promotion, on Adverse Events the Event (Reported) Language field defaulted to English. This issue impacted Vaults with the “Enable auto-set Inbox Item Localization by Reporter Country” setting enabled and the Localization field hidden on the Inbox Item layout. | SAF-31844 |
Fixed an issue with which values populate the B.3.2 (Results of tests and procedures relevant to the investigation of the patient) data element on E2B(R2) export. Now, the B.3.2 data element is mapped from the following Case Test Result fields:
Where these values are populated, they are exported to a limit of 2,000 characters. |
SAF-31935 |
|
With this feature, Vault Safety will support the evaluation of additional cross-reporting scenarios for situations where there are multiple cross-reporting obligations within the same jurisdiction. Enablement: Support Default Impact: None GxP Risk: High |
SAF-31952 |
Fixed an issue where, when a Vault included large Watchlists and Datasheet libraries, system performance was slow during the following tasks:
|
SAF-31968 & SAF-31993 |
| Fixed an issue where, when a Vault had a large number of Studies, Inbox Items loaded slowly. | SAF-31972 |
| Fixed an issue with system performance when loading a Domestic Case with localized dual-entry fields. | SAF-31987 |
| Fixed an issue with the Case Product Indication (Reported) field on Domestic Cases where the MedDRA browser appeared in English, instead of the Localized language on the Case. | SAF-31990 |
| Fixed an issue where, when promoting an Inbox Item to a Case, the system did not snapshot the Patient RoA TermID and TermID Version to the first Case Product Dosage record for Combination Products. | SAF-32059 |
| Fixed an issue where system performance was slow when the Re-evaluate Reporting Obligations action was run. | SAF-32139 |
| Fixed an issue where system performance was slow when manually creating a Domestic Case Product record. | SAF-32240 |
| Fixed an issue where, after promoting a Localized Inbox Item, the value in the localized Case Product (Reported) field was not populated on the Case. | SAF-32317 |
| Fixed an issue where, when generating E2B(R3) reports, if the Retransmit field was set to No, the C.1.6.1.r.1 Documents Held by Sender data element was not populated with the text from the Attachment Description and Attachment Description Continued fields from Case documents of the Case > Source > Attachment type. | SAF-32428 |
| Fixed an issue where, when an update was made to an Email Cover Letter Template that was referenced on multiple Email Profiles, when the Re-evaluate Reporting Obligations action was run, some Transmission documents failed to generate. | SAF-32490 |
| Fixed an issue where, when the Evaluate Reporting Obligations was run on a Study Case that included a non-Study product, the system incorrectly evaluated the non-Study product as the most conservative product when generating Distributions. | SAF-32492 |
| Fixed an issue where, after promoting an Inbox Item with a Combination Product to a Case, Product Registrations for Product Constituents were not snapshotted to the Case. | SAF-32523 |
| Fixed an issue where, when a Domestic Case Assessment included only one result, creating a Case product record was prevented. | SAF-32732 |
| Fixed an issue where, when generating an FDA 3500A report for a Study Case, if the Study Registration Number was blank the report was not generated. | SAF-32847 |
Fixed an issue where Vault Safety did not include the following AER-tagged EDQM Routes of Administration terms:
Vault Administrators must add the mappings for these EDQM terms. Mapping is managed through Business Admin > EDQM Mappings. |
SAF-32986 |
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-13160000 | N/A |