Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
Note An asterisk (*) next to the issue number denotes an internally found defect filed during the development of Limited Release features.
Intake
| Category | Description | Issue Number |
|---|---|---|
| Create AER | Fixed an issue where a server error appeared when a user assigned the Lock Manager role tried to create an AER. | SAF-5907* |
| E2B Import | Fixed an issue where Adverse Events were not being included in Case headlines upon E2B Import if a MedDRA Event was not selected. | SAF-7439 |
| E2B Import | Fixed an issue where an E2B import failed when importing an E2B file with an invalid Date of Birth value. | SAF-7360 |
| E2B Import | Fixed an issue where the acknowledgment failed to generate when importing E2B files through Vault API or AS2 Gateway. | SAF-7169* |
| E2B Import | Fixed an issue where, when importing EMA E2B (R3) where Assessment Results use E2B Codes instead of plain text, values from the file were not always mapped to the respective default E2B code. | SAF-6528 |
| E2B Import | Fixed an issue where E2B (R3) files were failing to import if a Case Product was linked to a different Organization than the E2B document in the vault library. | SAF-6484 |
| E2B Import | Fixed an issue where, when using B.4.k.5.3 in an E2B (R2) file, product dosages were aggregated on import. | SAF-6078 |
| Case Promotion | Fixed an issue where users could create duplicate Cases by clicking “Back to the previous page" after promoting an AER to a Case. | SAF-5781 |
| Case Promotion | Fixed an issue where a "Product record not found" error appeared when promoting an E2B AER with a high number of Case Products with dosages. | SAF-5526* |
| Case Promotion | Fixed an issue where Follow-Up Cases promoted from a non-E2B AER did not have the Case Number populated. | SAF-5501* |
| Case Promotion | Fixed an issue that was causing a “ProtectedRollbackException” error when promoting an AER to a Follow-Up Case. | SAF-5444* |
| Case Promotion | Fixed an issue where the Assessment Result of an AER did not copy over when a user opened a new Study Case. | SAF-6144* |
Case Processing
| Category | Description | Issue Number |
|---|---|---|
| Data Entry | Fixed an issue where the “Determine Due Date” action was calculating the Case Due Date incorrectly. | SAF-8501 |
| Data Entry | Fixed an issue where Case Products could not be saved if the Dosage subsection was populated with a custom entry. | SAF-7550 |
| Data Entry | Fixed an issue where users were unable to save Case Product when they entered a custom Dosage unit. | SAF-7500 |
| Data Entry | Fixed an issue where the text was not fully displayed in the Remedial Action-Other field on the FDA 3500A form generated from a Transmission. | SAF-7404* |
| Data Entry | Fixed an issue where the Medical Review Timeline did not display the Case Product and its respective Product Dosage. | SAF-7389* |
| Data Entry | Fixed an issue where the Frequency text and drop-down fields remained visible on screen after deleting the Dosage overlay. | SAF-7320* |
| Data Entry | Fixed an issue where a console error appeared when a user entered a numeric value in a Unit Picker field. | SAF-7319 |
| Data Entry | Fixed an issue where the Gender field value was not appearing on AER or Cases for non-Vault Owners when it was marked as deprecated by a Vault Owner. | SAF-7602* |
| Data Entry | Fixed an issue where a Read-only Value field was left blank in Case Product when its Unit field was blank. Now, the system will issue an “Invalid” icon when a Unit field is left blank. | SAF-6804 |
| Data Entry | Fixed an issue where users could select invalid Reason Omitted (nullflavor) values from combined control fields during data entry. | SAF-6043 |
| Data Entry | Fixed an issue where, when a Dosage is marked for deletion, the delete overlay of Dosages is misplaced on the screen after expanding or collapsing the above subsection. | SAF-5759* |
| Data Entry | Fixed an issue where, when tabbing out of the Dose and Indication selection in Case Product, the fields were being cleared. | SAF-4702 |
| Data Entry | Fixed an issue where the Date Picker did not close after selecting a Receipt Date on the AER. | SAF-3954 |
| Triage | Fixed an issue where, if a preconfigured Study Site had a blank Registration field, a NullPointerException error was appearing when users tried to complete the Triage task. | SAF-5620 |
| Auto-Calculation | Fixed an issue where, when the Case Product registration was updated, the system set the Expedited flag to NO instead of leaving the Expedited flag as-is. | SAF-5904* |
| Auto-Calculation | Fixed an issue where, when a new Adverse Event was added to a Case, the system was not automatically calculating the Latency field. | SAF-6927 |
| Auto-Calculation | Fixed an issue where the system was not automatically calculating the Latency field on Case Assessment records after a Case was created from an imported E2B file. | SAF-6374 |
| Auto-Calculation | Fixed an issue where a server error appeared when multiple dosages are updated or created on Case Product and result in auto-calculation. | SAF-6168* |
| Auto-Calculation | Fixed an issue where the End date was calculated incorrectly when the Case Adverse Event contains an Onset date and Outcome is Unknown or left blank. | SAF-6103* |
| Auto-Calculation | Fixed an issue where the Age at Onset field was not being recalculated correctly on Cases imported from an E2B file with multiple Case Adverse Event records. | SAF-5632 |
| Expectedness | Fixed an issue where, when a non-primary Adverse Event or Product was updated to primary, Case level Expectedness was not updated. | SAF-7042* |
| Expectedness | Fixed an issue where after you manually changed the auto-calculated Expected field to set the value to Yes (Overriden), the system updated the Expedited field to No instead of leaving the Expedited field as-is. | SAF-6123 |
| Expectedness | Fixed an issue where different Expectedness values were being populated on initial Cases and their corresponding Follow-Up Cases. | SAF-6096 |
| Expectedness | Fixed an issue where, when an AER was promoted to Case with an empty Seriousness field, the Expectedness field on the resulting field was set to Yes if there were no preconfigured Product Datasheets. | SAF-5834 |
| Relatedness | Fixed an issue where the system was incorrectly populating Relatedness as "Unknown". | SAF-6447 |
| Narratives | Fixed an issue where the Title field for Case Narratives was not being populated correctly. | SAF-6223* |
| Narratives | Fixed an issue where users were not receiving a warning notification when uploading a Narrative Document in an unsupported format. | SAF-6055 |
| Blinding | Fixed an issue where a SOC product in a blinded study case was getting created as Blinded instead of Open. | SAF-6255* |
| Watchlists | Fixed an issue where the Case Expedited field was being populated when the Event MedDRA was on the DME watchlist and the Product Registration Agency was FDA. | SAF-5802, SAF-5795 |
| Watchlists | Fixed an issue where the AESI Watchlist Tag was unable to be added on Study cases. | SAF-5741* |
| Medical Review | Fixed an issue where the Dosage Details on the Medical Review Timeline contained extra decimals compared to the Dosage Details of the Case Product. | SAF-6125* |
| Medical Review | Fixed an issue where a server error appeared when a Case Product Dosage did not have a Frequency Value and a First Admin Date. | SAF-6124* |
| Medical Review | Fixed an issue where, when the Case Adverse Event had Onset Date and Outcome: “recovered/resolved” or “recovered/resolved with sequelae”, the Timeline bar is empty instead of displaying the Milestone Marker. | SAF-6119* |
| Medical Review | Fixed an issue where the Date values in the Medical Review Timeline hovercard were displayed incorrectly when the Case AE contains an Onset or Cessation date and Duration < 1 day. | SAF-6116* |
| Medical Review | Fixed an issue where the Medical Review Timeline hovercard only displayed the year value when the Onset date of the Case Adverse Event was the first day of any month. | SAF-6095* |
| Medical Review | Fixed an issue where the Date Range field for the Medical Review Timeline was misplaced on the screen when the user tried to edit it. | SAF-6094* |
| Medical Review | Fixed an issue where, when the Case Adverse Event had the same start and end date, the Medical Review Timeline bar was empty instead of displaying a Milestone Marker. | SAF-6080* |
| Medical Review | Fixed an issue where the Medical Review Timeline Header was not displayed correctly when the Case Adverse Event contained a start and end date. | SAF-6079* |
| Medical Review | Fixed an issue where “highcharts.com” was displayed at the bottom right corner of the Medical Review Timeline section. | SAF-6075* |
| Medical Review | Fixed an issue where the Case page could not load when the Medical Review Timeline section control was added to the Case page layout. | SAF-6049* |
| Follow-Ups | Fixed an issue where an error message appeared without stating the actual cause of the error after creating a Follow-Up Case with two open Case versions. | SAF-6669 |
| Follow-Ups | Fixed an issue where Non-Expedited Closed Cases with SAE tags changed to Expedited upon creating Follow-Ups. | SAF-6341 |
| Follow-Ups | Fixed an issue where a duplicate Case Adverse Event record was created on the follow-up case when the auto-calculated Expected value was updated on the original case. | SAF-6257* |
| Follow-Ups | Fixed an issue where a system error appeared when trying to create a follow up Adverse Event Report from potential matches with a different Adverse Event MedDRA. | SAF-6179* |
| Follow-Ups | Fixed an issue where you could not create a Follow-Up Case from a Case containing multiple Case Product or Case Adverse Event records with identical names. | SAF-6157 |
Coding
| Category | Description | Issue Number |
|---|---|---|
| MedDRA | Fixed an issue where the Organization field was not required on the MedDRA Criteria object. | SAF-8334 |
| MedDRA | Fixed an issue where, when an Administrator changed the active MedDRA version, the MedDRA version was not appearing on Cases. | SAF-7966* |
| MedDRA | Fixed an issue where the MedDRA Dictionary was not being consolidated with previously loaded versions, resulting in duplicate entries in the DME List. | SAF-7424 |
| MedDRA | Fixed an issue where, when a user navigated to the next page in the MedDRA browser and then searched for a new term, no results were shown. | SAF-7336* |
| MedDRA | Fixed an issue where, when a user navigated to the next page in the MedDRA browser and then changed the filter level (i.e. from SOC-level to LLT-level), no results were shown. | SAF-7182* |
| MedDRA | Fixed an issue where, when using MedDRA Auto-code to search for a term, the term is coded as “Non-Primary”. | SAF-7142* |
| MedDRA | Fixed an issue where you could not use the pagination input box in the MedDRA browser to navigate to a different result page. | SAF-7041* |
| MedDRA | Fixed an issue where the selected MedDRA term was not displayed on the first page after re-opening the browser. | SAF-6038* |
| MedDRA | Fixed an issue where the Binoculars icon next to the Event (Reported) field was missing on MedDRA control. | SAF-5893* |
| MedDRA | Fixed an issue where, when a MedDRA term was coded to a non-primary SOC, the term was not shown in results upon exiting and re-entering the browser. | SAF-5854* |
| MedDRA | Fixed an issue where the coded value of the MedDRA term was not shown in results upon exiting and re-entering the browser. | SAF-5850* |
| MedDRA | Fixed an issue where the selected MedDRA term was not shown in results upon exiting and re-entering the browser. | SAF-5828* |
| MedDRA | Fixed an issue where, when three keywords were inputted in the MedDRA search bar, no results were shown. | SAF-5827* |
| MedDRA | Fixed an issue where a descriptive error message did not appear below the MedDRA field when a non-primary MedDRA term was selected for a Case Adverse Event. | SAF-5735* |
| MedDRA | Fixed an issue where the combined MedDRA control could not be created or updated in the Case Product Indication Section Control. | SAF-5079* |
| MedDRA | Fixed an issue where, when trying to change the MedDRA Query Level, the record did not update and an incorrect success message appeared instead of displaying a valid error message. | SAF-5929 |
Report Generation
| Category | Description | Issue Number |
|---|---|---|
| E2B Export | Fixed an issue where the Patient RoA field was not being exported correctly for HC E2B (R2) exports. | SAF-8519 |
| E2B Export | Fixed an issue where, when generating an ICH or EMA E2B (R3) file, the Start and End date fields in the Case Adverse Event record were exported as invalid E2B values in section E when these fields had nullflavors. Also, when the Case Adverse Event record contained only the End date and Duration values, the corresponding Section E data elements were exported in an incorrect order. | SAF-7502 |
| E2B Export | Fixed an issue where, when a Case contained more than one Case Assessment with the same outboundRelationship fields populated (i.e. Start and End Date, Recurrence), the outboundRelationship fields were exported in an incorrect order in the generated E2B (R3) file. | SAF-7322 |
| E2B Export | Fixed an issue where an error appeared when uploading an EMA E2B (R3) XML file to EVWEB and submitting the same file through EMA Gateway. | SAF-7279 |
| E2B Export | Fixed an issue where the Manufacturer tag was missing in E2B (R2) files generated for Cases regarding a combination Product with Device Constituent. | SAF-7231* |
| E2B Export | Fixed an issue where the Combination Products’ Device Constituent fields were getting exported in the Health Canada E2B (R2) file. | SAF-7132* |
| E2B Export | Fixed an issue where the Product Code in Combination Products with Device Constituents was not getting exported in the FDA E2B (R2) file. | SAF-7125* |
| E2B Export | Fixed an issue where blank EMA E2B (R3) fields were included in the XML file and caused an EMA submission failure. | SAF-6923 |
| FDA 3500A | Fixed an issue where, when multiple Dosages overflowed from Section C.3 of FDA 3500A forms onto an additional page, this page would go missing. | SAF-7840 |
| FDA 3500A | Fixed an issue where, when Malfunction was selected for Device Report Type, both Adverse Event and Product Problem were selected in the FDA 3500A form instead of Product Problem only. | SAF-7356* |
| CIOMS I | Fixed an issue where generated CIOMS I forms showed both the two-letter country code and the country name in the address fields. Now, the system populates the country name only without the country code. | SAF-6138 |
Transmissions
| Category | Description | Issue Number |
|---|---|---|
| Reporting Rules | Fixed an issue where Transmission records were being created for all products and studies regardless of registration, country, or agency. Now, Transmission records are only created when studies or products are registered in association with Cases. | SAF-7453 |
| Reporting Rules | Fixed an issue with Study Report Types where Submission records were being created on Follow-Ups if the initial Case had a completed Submission, even if it was not tagged as SUSAR. This fix does not affect the current behaviour for Post-Market Report Types. | SAF-6834 |
| Reporting Rules | Fixed an issue where reporting rules were generating additional Submissions and Distributions on Follow-Up Study Cases when the Study was not associated with those reporting rules. | SAF-7445 |
| Reporting Rules | Fixed an issue where, when evaluating reporting obligations, the Case Adverse Event was not being filtered based on agency country. | SAF-6003* |
| Reporting Rules | Fixed an issue where a Submission record was not automatically generated for Follow-Up Cases when the initial imported Case did not have a Submission. | SAF-6672 |
| Reporting Rules | Fixed an issue where the system was automatically generating Submission records for non-SUSAR and non-SAE Follow-Up Cases. | SAF-5988 |
| Transmission Generation | Fixed an intermittent issue where Transmission documents were not automatically generated from FDA and EMA Submissions. | SAF-7357* |
| Transmission Generation | Fixed an issue where a system error appeared when trying to create a Distribution from Combination Products with a registration and reporting Organization set. | SAF-7098* |
| Gateway Transmissions | Fixed an issue where EMA EVWEB XSD validation failed after selecting “Cyclical”, “As Necessary”, or “Total” for Frequency instead of a value. | SAF-6806 |
Aggregate Reports
| Category | Description | Issue Number |
|---|---|---|
| PSUR | Fixed an issue where Cases with Start Dates/End Dates after Receipt Dates were not being included in PSUR reports. | SAF-8596* |
| PSUR | Fixed an issue where the Adverse Event was exported with Event MedDRA instead of in format Event Reported (Event MedDRA) when generating PSUR Summary Tabulations. | SAF-5950* |
| PSUR | Fixed an issue where PSUR reports failed to generate when a non-serious case has the Expectedness field left blank. | SAF-5933* |
| PSUR | Fixed an issue where Null appeared on CIOMS II listings when Event MedDRA was not provided on the case. | SAF-5921* |
| PSUR | Fixed an issue where, when Adverse Events on Study and Literature Cases did not have a Case Assessment, they were not counted on the PSUR Summary Tabulation. | SAF-7887 |
| PSUR | Fixed an issue where, when Adverse Events on Study and Literature Cases did not have a Case Assessment, they were not counted on the PSUR Summary Tabulation. | SAF-5875* |
| DSUR | Fixed an issue where Patient Initials/ID instead of Investigational MRN was appearing as Patient ID on DSUR Line Listings and Appendix if both fields were populated. | SAF-8484 |
| PBRER | Fixed an issue where the interval column did not include the latest New Info Date in range for PBRER Number of Product Reactions by Term for Postmarketing Sources table. | SAF-6648 |
| PBRER | Fixed an issue where cumulative case calculations were not considering the correct start date when generating aggregate reports. | SAF-6605 |
| PBRER, PADER |
Fixed an issue where Superseded initial versions of Cases were not being included in cumulative PBRER and PADER reports. | SAF-7897 |
System
| Category | Description | Issue Number |
|---|---|---|
| Audit Log | Fixed an issue where the audit log recorded that the system created Follow-Up Cases instead of the user who triggered the action. | SAF-6344, SAF-6535 |
| Audit Log | Fixed an issue where the audit log was not turned on for Admin objects. | SAF-7474 |
| Audit Log | Fixed an issue where the audit log was not turned on for system-managed objects. | SAF-7540 |
| Object Administration | Fixed an issue where any user was able to edit or delete records associated with the Device Code Object. | SAF-8023 |
| Object Administration | Fixed an issue where a server error appeared when navigating to the Case page after Read permission was removed from the Name (MedDRA) field in the Indications subsection. | SAF-7242 |
| Object Administration | Fixed an issue where a user could successfully delete an Object when their Delete permission was disabled. | SAF-7236 |
| Object Administration | Fixed an issue where a user could successfully edit the Name (Reported) field when their Edit Object Field permission was disabled. | SAF-7232 |
| Object Administration | Fixed an issue where a server error appeared when a user without permissions to read User security tried to create records on Safety objects with an api_name field. | SAF-6828 |
| Lifecycles & Worflows | Fixed an issue where a State name was misspelled on the Aggregate Template Lifecycle. | SAF-5662 |
| Lifecycles & Worflows | Fixed an issue where the user was unable to change the state of the case to Approved once the user locks the case. | SAF-5985* |
| Lifecycles & Worflows | Fixed an issue where a Study Case Product on Open case went to Unblinded lifecycle state instead of Open lifecycle state. | SAF-5968* |
| Notifications | Fixed an issue where a failure notification did not appear when a user tried to generate an FDA 3500A form from a Case where a Device-type Product is the only and primary Case Product. | SAF-6794* |
| Notifications | Fixed an issue where a descriptive error message did not appear when Follow-Up Case creation failed due to a Case field referencing an inactive Controlled Vocabulary record. | SAF-6449 |
| Notifications | Fixed an issue where users were unable to open links to documents or Cases from vault notifications. | SAF-5874 |
| Notifications | Fixed an issue where the “Transmission Profile already exists” error was displaying incorrectly. | SAF-5662 |
| VMC | Fixed an issue where a server error appeared when a user tried to view Case Product page from VMC > View Configuration. | SAF-6832, SAF-6158 |
