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.

New Record: Updated Records:
PDF-13162000 N/A

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:
  • Evaluate Regulatory Conformance
  • Evaluate Reporting Obligations
  • Assign Due Date
  • Submit to Gateway
 
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:
  • If the B.4.k.5.1 (Dose Value) and B.4.k.5.2 (Dose Unit) values exceed data element character limits, additional text is included in the B.4.k.6 (Dosage Text) data element, preceded by the label "DOSAGE:".
  • If the B.4.k.5.6 (Cumulative Dose Value) and B.4.k.5.7 (Cumulative Dose Unit) values exceed data element character limits, additional text is included in the B.4.k.19 (Additional Information on Drug) data element, preceded by the label "CUMULATIVE DOSAGE:".
Where these values are populated, they are exported to a limit of 2,000 characters.
 
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:
  • Test Name (LLT)
    If Test Name (LLT) is blank, the Test Name (Reported) field is mapped instead.
  • Test Date
  • Result (Code)
  • Result (Text)
  • Comments

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:
  • Creating or editing a Case Adverse Event
  • Manually creating a Case Assessment
 
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:
  • ROA-20085000
  • ROA-20082000
  • ROA-20083000

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

August 25, 2022

Release Number: 22.2.0.2 | Build Number: 430