Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
The following fixes are introduced in 22R3. For details about fixed issues in the Vault Platform in 22R3, see the Vault Release Notes.
Intake
| Category | Description | Issue Number |
|---|---|---|
| Case Promotion | 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 |
| Case Promotion | Fixed an issue where, when a Study had Unspecified Products, the Product Name was not included in the Case name. | SAF-33641 |
| Case Promotion | 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 |
| Case Promotion | 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 |
| Case Promotion | 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 |
| Document Intake | Fixed an issue with the Import Narrative API endpoint where, if an error occurred during import, in the resulting API response the JSON error message was incorrectly formed and contained two root nodes. | SAF-34570 |
| Duplicate Detection | Fixed an issue where, when the Deep Duplicate Search feature was enabled, if promoting an Inbox Item with a Combination Product the system did not find Potential Matches for Cases with the same Combination Product. | SAF-33327 |
| E2B Import | Fixed an issue where, when an E2B file included a Combination Product, import failed when creating an AER or Case. | SAF-31979 |
| E2B Import | Fixed an issue where, when importing an EMA E2B(R3), the GB country code did not default to "United Kingdom (Great Britain)" as expected for E.i.9 (Identification of the Country Where the Reaction / Event Occurred). In addition, the XI country code could not be imported. | SAF-32724 |
| E2B Import | Fixed an issue where the system matched E2B-imported countries to inactive countries. | SAF-33989 |
| E2B Import | 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 |
| E2B Import | 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 |
| E2B Import | 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 |
| E2B Import | Fixed an issue where, when an E2B(R2) file included assessments that were not linked to an adverse event, Case import failed. | SAF-34957 |
| E2B Import | Fixed an issue with E2B(R3) import where, if the C.5.2 Study Name data element included more than 1,500 characters, the import failed. | SAF-36146 |
Case Processing
| Category | Description | Issue Number |
|---|---|---|
| Blind Protection, Follow-Ups |
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-34277, SAF-35126 |
| Case Assessment | 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 |
| Case Locking | Fixed an issue where, when the Void Case user action was initiated before locking the Case, the system did not notify the user that they must lock the Case and try again. | SAF-34777 |
| Case Locking | Fixed an issue where, when strict case locking was enabled, date fields set up as exceptions to strict case locking remained uneditable. | SAF-34825 |
| Data Entry | Fixed an issue where, in some instances, Case Dosage section fields became read only. | SAF-33184 |
| Data Entry | Fixed an issue where system performance was slow in certain circumstances while processing a Study Case. | SAF-33917 |
| Data Entry | 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 |
| Domestic Case | Fixed an issue with Localized Case Assessments where they were not generated using the Local Datasheet for the country in the Localization field. | SAF-31850 |
| Domestic Case | Fixed an issue where, when a Domestic Case had the Localization field set to Global, the system did not run the rules engine or validations and did not assign a Due Date to the Case. | SAF-35103 |
| Follow-Ups | 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 |
| Follow-Ups | 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 |
| Follow-Ups | Fixed an issue where, when a Localized Case did not include a localized Narrative document, Follow-Up Cases could not be created. | SAF-34078 |
| Follow-Ups | 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 |
| Follow-Ups | Fixed an issue where, when strict case locking was enabled, in some cases merge to Follow-Up could not be completed. | SAF-34503 |
| Follow-Ups | 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 |
| Follow-Ups | Fixed an issue where Follow-Up Case creation failed when an Inbox Item included more than 500 grandchild records. | SAF-35226 |
| Follow-Ups | 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 |
| Localization | 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 |
Coding
| Category | Description | Issue Number |
|---|---|---|
| MedDRA | 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 |
| MedDRA | Fixed an issue where, if an Inbox Item was created and the active MedDRA version for the system was updated before Case promotion, the previous MedDRA version still appeared on the Case after promotion. | SAF-35516 |
Report Generation
| Category | Description | Issue Number |
|---|---|---|
| E2B Export | 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, SAF-35042 |
| E2B Export | Fixed an issue where, in some instances, a system error occurred when generating custom E2B formats. | SAF-33834, SAF-34074 |
| E2B Export | 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 |
| E2B Export | 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 |
Transmissions
| Category | Description | Issue Number |
|---|---|---|
| Cross Reporting | 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 |
| Cross Reporting | Fixed an issue where the system generated cross reports for External Products. | SAF-33825 |
| Cross Reporting | Fixed an issue where, when cross reporting based on Combination Product Substances, Combination Product Constituents were not included even when configured with the same Substance. | SAF-33874 |
| Cross Reporting | 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 |
| Cross Reporting | Fixed an issue where comparators were not considered investigational medicinal products for cross reporting. | SAF-35221 |
| Email Distributions | Fixed an issue where email cover letters were sent with merge field tokens, instead of the appropriate field values. | SAF-33738 |
| Email Distributions | Fixed an issue where, when the email did not include a subject line and the transmission failed, the system did not provide a notification. | SAF-33979 |
| Email Distributions | 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 |
| Email Distributions | Fixed an issue where, if an Email Submission record remained in the ‘Queued for Submission’ state for more than 24 hours, then the Email Submission record’s state remained as ‘Queued for Submission’ instead of changing to the Error state. | SAF-34486 |
| Email Distributions | 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 |
| Email Distributions | 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 |
| Gateway Transmissions | 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 |
| Reporting Rules | 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 |
| Submissions/Distributions | Fixed an issue where, when the Evaluate Regulatory Conformance action failed, the system did not provide a notification. | SAF-34354 |
| Transmission Generation | 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 |
| Transmission Generation | 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 |
| Transmission Generation | Fixed an issue where, when a Case was Closed, saving edits on Transmissions and Transmission Messages was prevented. | SAF-34468 |
| Validation Rules | Fixed an issue where, when running validations for Test Result (value / qualifier), when there was an error in the resultvalue_text__v field, the system showed the error in the result_value_v field. | SAF-34446 |
Aggregate Reporting
| Category | Description | Issue Number |
|---|---|---|
| PADER | 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 |
System
| Category | Description | Issue Number |
|---|---|---|
| Audit Log | Fixed an issue where, when a Case included large amounts of data, the system was slow when running validations. | SAF-34487 |
| Object Administration | Fixed an issue where bulk unblinding all Cases under a Study was prevented when one or more Cases was locked. | SAF-33197 |
| Notifications | 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 |
| Perfomance | Fixed an issue where system performance was slow when calculating and assigning watchlist tags. | SAF-32716 |
| Performance | 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 |
| Performance | Fixed an issue where system performance was slow during Case processing. | SAF-34105 |
| Performance | Fixed an issue where running the Evaluate Regulatory Obligations action caused system issues. | SAF-34116 |
| Performance | Fixed an issue where system performance was slow when running the reporting rules engine. | SAF-34131, SAF-34559 |
| Performance | Fixed an issue where system performance was slow when running the Evaluate Regulatory Obligations action. | SAF-34144 |
| Performance | Fixed an issue where, when a Case included large amounts of data, the system was slow when running validations. | SAF-34146 |
| Performance | Fixed an issue where, after generating Transmissions on a global Case, system performance was slow during Foreign Localized Case creation. | SAF-34237 |
| Performance | Fixed an issue where queries on Case Products may have caused performance issues. | SAF-34238 |
| Performance | Fixed an issue where, in some cases, Vault Safety ran redundant queries, which may have caused performance issues for users. | SAF-34345 |
| Performance | Fixed an issue where system performance was slow when generating CIOMS I forms. | SAF-34494 |
| Performance | Fixed an issue where system performance was slow during E2B import. | SAF-34498 |
| Performance | Fixed an issue where system performance was slow when creating Domestic Localized Cases. | SAF-34499 |
| Performance | Fixed an issue where system performance was slow when loading Inbox Item Details. | SAF-34626 |
| Performance | Fixed an issue where system performance was slow when running the Evaluate Regulatory Obligations action. | SAF-34697 |
| Performance | Fixed an issue where queries on Controlled Vocabularies may have caused performance issues when loading pages. | SAF-34747 |
| Performance | Fixed an issue where system performance was slow when generating E2B(R2) files. | SAF-34787 |
| Performance | Fixed an issue where, when a Case included large amounts of data, the system was slow when generating E2B(R3) files. | SAF-34958 |
| Performance | 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 |
| UI/UX | 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 |
| UI/UX | Fixed an issue where, when errors occurred during Case promotion, system error messages did not describe the cause of the issue. | SAF-34701 |
