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 21R2. For details about fixes issues in the Vault Platform in 21R2, see the Vault Release Notes.
Safety
The following Vault Safety issues are fixed in 21R2.
Intake
| Category | Description | Issue Number |
|---|---|---|
| E2B Import | Fixed an issue where the Last Dose Latency value was not populated on the Case from the imported E2B(R2) file. | SAF-16741 |
| E2B Import | Fixed an issue where, when an E2B file containing multiple ICSRs was imported, if one of the cases resulted in an error, an Inbound Transmission for that single case was not generated. | SAF-16856 |
| E2B Import | Fixed an issue where a warning notification did not appear for conflicting registration number when importing E2B(R2) merged products. | SAF-17135 |
| E2B Import | Fixed an issue where an incorrect failure notification appeared for manual E2B imports. | SAF-17310 |
| E2B Import | Fixed an issue where some sections in ACK were missing when a single E2B file was not imported with errors. | SAF-16971 |
| E2B Import | Fixed an issue where the Case Assessment Results were not created after importing the E2B file and promoting it to Case. | SAF-16018 |
| E2B Import | Fixed an issue where the Inbound Transmission Origin field was not being set by the source document's Origin field. | SAF-17467 |
| E2B Import | Fixed an issue where, when an E2B file containing a single ICSR was imported successfully, two Message Acknowledgments (ACKs) appeared, one of which incorrectly stated that the message could not be parsed (transmissionacknowledgementcode = 03). | SAF-17428 |
| E2B Import | Fixed an issue where an E2B file and Inbound Transmission could not be imported due to an invalid value on the Origin field. | SAF-17545 |
| E2B Import | Fixed an issue where a Case was being blind protected even when there was no blinded study in the Library. | SAF-17051 |
| E2B Import | Fixed an issue where, when importing an E2B(R2) file, the Source field in the second generated Case Assessment Result was populated with Non Health Care Professional instead of being left blank. | SAF-17522 |
| E2B Import | Fixed an issue where the Multi-Case E2B Import via API/AS2 enhancement was not automatically enabled in the initial release of Vault Safety 21R1.0. | SAF-17216 |
| E2B Import | Fixed an issue where E2B imports were failing due to an intermittent conflict with vault rendition processes. Document renditions will now be suppressed during the E2B import process and will generate once a user views the document. | SAF-18902 |
| E2B Import | Fixed an issue with EMA reporting by supporting the import of Patient Drug History Name Parts (D.8.r.1.EU.1 to D.8.r.1.EU.8) and Parent Drug History Name Parts (D.10.r.8.r.1.EU.1 to D.10.r.8.r.1.EU.8) from EMA E2B(R3). | SAF-19343 |
| E2B Import | Fixed an issue with EMA reporting by supporting the import of Patient Drug History Substance fields section (D.8.r.EU.r) and Parent Drug History Substance fields section (D.10.8.r.EU.r) from EMA E2B(R3). | SAF-19345 |
| E2B Import | Fixed an issue where the Drug Name (Reported) field in Case Drug History was not imported correctly from E2B(R3). | SAF-19347 |
| E2B Import | Fixed an issue where duplicate dosage records were created on E2B(R2) import if the Product had multiple indications and if the dosage information was repeated in all E2B drug sections. | SAF-17754 |
| E2B Import | Fixed an issue with E2B imported Cases where, the Study Product was not set as Primary if the Study was Blinded. | SAF-18735 |
| E2B Import | Fixed an issue with E2B imported Cases where, the Relatedness field was set to Unknown even when the Assessment Result was set to Reasonable Possibility. | SAF-18737 |
| E2B Import | Fixed an issue where partial dates were not accepted for the Date of Death field (D.9.1) on E2B(R3) import. | SAF-18560 |
| E2B Import | Fixed an issue where, when an E2B file was imported manually or through the API to an AS2 Transmission Profile, the logs displayed a NullPointerException (NPE) error. | SAF-18759 |
| E2B Import | Fixed an issue where the Outcome field on the Case Adverse Event record was not populated with "Unknown" and was left blank when the E2B(R2) source file had an invalid code for B.2.i.8 (reactionoutcome). | SAF-18449 |
| E2B Import | Fixed an issue where system-generated E2B(R2) acknowledgment messages (ACKs) were not being populated with any value in the M.1.4 Message Number field. | SAF-17334 |
| E2B Import | Fixed an issue where a Case Assessment and Case Assessment Result were generated for an E2B imported Case with a non serious adverse event. | SAF-17618 |
| E2B Import | Fixed an issue where, when importing an E2B(R2) file, the Case Assessments and Case Assessment Results were created for non-suspect or concomitant Products. | SAF-17592 |
| E2B Import | Fixed an issue where two Inbound Transmissions were generated for a single E2B file during manual import. | SAF-18050 |
| E2B Import | Fixed an issue where a conflict warning appeared during E2B import when some Case Assessment Results were left blank or null. | SAF-18389 |
| E2B Import | Fixed an issue where, when an E2B file containing multiple ICSRs was imported, if one of the cases resulted in an error, an Inbound Transmission for that single case was not generated. | SAF-16856 |
| E2B Import | Fixed an issue where the Inbound Transmission was going to Error state with no error message on manual E2B import. | SAF-19411 |
| E2B Import | Fixed an issue where, when importing an E2B(R2) file, the generated ACK for A.1.3 (icsrmessagesenderidentifer) was left blank on the Inbound Transmission. | SAF-17872 |
| Case Promotion | Fixed an issue where you could not promote AERs to Cases if there was an inactive custom Drug Role Controlled Vocabulary with an E2B code of 1 (suspect) in the Vault. | SAF-17288 |
| Duplicate Detection | Fixed an issue where duplicate detection did not find any potential matches for Cases with matching Worldwide UIDs. | SAF-16097 |
| Duplicate Detection | Fixed an issue where, after promoting an AER to Case and specifying it as a Follow-Up Case during duplicate detection, a duplicate Reporter Case Contact record was created. | SAF-18442 |
Case Processing
| Category | Description | Issue Number |
|---|---|---|
| Data Entry | Fixed an issue where the user was unable to save the Case page after editing if the Gestation value was 0. | SAF-16738 |
| Data Entry | Fixed an issue where an error appeared when setting the Case-level Study field that did not match the Study Product. | SAF-11704 |
| Data Entry | Fixed an issue where you could select a Product (Study) on a Case Product that was not associated with the Case-level Study, causing a mismatch between the Case Product and Study. | SAF-15176 |
| Data Entry | Fixed an issue where, if one record failed when updating records in batch, all the records in the batch failed. | SAF-17501 |
| Data Entry | Fixed an issue where some EMA-supported units of measurement were unavailable in Vault Safety. | SAF-17995 |
| Data Entry | Fixed an issue where the Strength field on Case Product Substances did not support decimals. | SAF-18268 |
| Data Entry | Fixed an issue where the Reason Omitted field was hidden in the Case Product Indication section after selecting Clear Selection. | SAF-17973 |
| Follow-Ups | Fixed an issue where, after removing a field from the Case Assessment, an error appeared during duplicate detection and the Follow-Up Case failed to create. | SAF-17719 |
| Follow-Ups | Fixed an issue where the case promotion action failed when configured as part of an automated system job (for example, SDK) due to a notification failure to System User. | SAF-18910 |
| Follow-Ups | Fixed an issue where E2B-imported Follow-Up Cases were not tagged with a Case Tag or Watchlist Tag. | SAF-16825 |
| Narratives | Fixed an issue where the Narrative Preview field was left blank on Imported Cases even when the narrative document was created. | SAF-18799 |
| Localization | Fixed an issue where, if there are multiple Localized Cases, the H.5.r section is duplicated with a local narrative translation for each Localized Case. | SAF-16303 |
| Watchlists | Fixed an issue where the DME watchlist tag was not updated on the case if the product has Registration in UK. | SAF-16747 |
| Watchlists | Fixed an issue where the watchlist tag did not update on the Case even though the Include Lower Levels field was set to Yes on the watchlist. | SAF-17702 |
| Watchlists | Fixed an issue where the DME watchlist tag was not updated on the case if the product has Registration in UK. | SAF-16747 |
| Auto-Calculation | Fixed an issue where the Cumulative Dose was not calculated correctly on the Case Product. | SAF-18289 |
| Auto-Expectedness | Fixed an issue with central MedDRA where the generated auto-expectedness didn't adhere to the Include Lower Levels option on the Local Datasheet. This resulted in the Expectedness field being incorrectly populated on the Expectedness record. | SAF-19406 |
Coding
| Category | Description | Issue Number |
|---|---|---|
| MedDRA | Fixed an issue where the system generated duplicate MedDRA records when a user uploaded the same MedDRA version zip file locally more than once. | SAF-16997 |
| MedDRA | Fixed an issue where duplicate MedDRA records were created when updating local MedDRA to a new version. | SAF-17449 |
| MedDRA/WHODrug | Fixed an issue where a server error appeared when a user with Business Admin permissions tried to navigate to the Dictionary page. | SAF-17265 |
| Dosage Form | Fixed an issue where Dose Unit ug/g was not available in the Case Product Dosage record after ICH/EMA E2B(R3) import or manual AER creation. | SAF-19440 |
Aggregate Reporting
| Category | Description | Issue Number |
|---|---|---|
| DSUR | Fixed an issue where the DSUR Interval Line Listings report was being generated with the incorrect file tab name. | SAF-17286 |
| DSUR | Fixed an issue where a generated DSUR aggregate report for List of Subjects Who Died During the Reporting Period included the superseded version of the Case. | SAF-18362 |
| PADER | Fixed an issue where Vaults that do not have the event_meddra_pt__c field were unable to generate the PADER Non-Primary Suspect Product Report. | SAF-17768 |
| PADER | Fixed an issue where, if the US Local Datasheet wasn't configured for the user's vault, the Case was not populated after generating PADER Tabulations with a non-15 day Case. | SAF-17750 |
| DSUR, PADER, PBRER, PSUR | Fixed an issue with aggregate reports where the Data Period End was not a required field but after saving the report, an error message appeared stating this field is required. | SAF-15478 |
Report Generation
| Category | Description | Issue Number |
|---|---|---|
| CIOMS I/FDA 3500A | Fixed an issue where the G.4 field on the FDA 3500A and CIOMS I form was populated with Receipt Date instead of New Info Date. | SAF-13197 |
| CIOMS I/FDA 3500A | Fixed an issue with logging during CIOMS I and FDA 3500A form generation where, when forms failed to generate due to issues with the case narrative document, the error logs did not provide sufficient troubleshooting information. The system now logs the Document ID of the case narrative. | SAF-16181 |
| FDA 3500A | Fixed an issue where field G.7 Type of Report was not populating on FDA 3500A forms for manually created Submissions or Distributions. | SAF-17932 |
| FDA 3500A | Fixed an issue where field G.7 Type of Report was not being populated with the appropriate report type for FDA 3500A generated previews. | SAF-17766 |
| E2B Export | Fixed an issue with EMA reporting by supporting the export of Patient Drug History Name Parts (D.8.r.1.EU.1 to D.8.r.1.EU.8) and Parent Drug History Name Parts (D.10.r.8.r.1.EU.1 to D.10.r.8.r.1.EU.8) from EMA E2B(R3). | SAF-19344 |
| E2B Export | Fixed an issue with EMA reporting by supporting the export of Patient Drug History Substance fields section (D.8.r.EU.r) and Parent Drug History Substance fields section (D.10.8.r.EU.r) from EMA E2B(R3). | SAF-19346 |
| E2B Export | Fixed an issue with EMA reporting and EVHUMAN submissions by prioritizing the export of assessment source, method, and result (G.k.9.i.2.r.1, G.k.9.i.2.r.2, G.k.9.i.2.r.3) code values instead of text values. | SAF-19348 |
Transmissions
| Category | Description | Issue Number |
|---|---|---|
| Reporting Rules | Fixed an issue where a "NullPointerException" error appeared when evaluating reporting obligations for a Case. | SAF-16309 |
| Reporting Rules | Fixed an issue where the reporting rules engine did not generate Submissions when the Event Country did not match the Product or Study Registration Country, even if both countries share the same agency (such as EMA). | SAF-18881 |
| E2B Validation | Fixed an issue where the FDA.FDA.D.12-1 and FDA.FDA.D.11-1 validation rules failed for Ethnicity and Race with valid nullFlavors. | SAF-16554 |
| E2B Validation | Fixed an issue where a warning was not appearing for FDA VAERS validation rule FDA.FDA.D.8.r.8a when the Patient Age at Vaccination value exceeded three digits. | SAF-16672 |
| E2B Validation | Fixed an issue where the vault object case_version_v was being used instead of case_drug_history_v for validation criterias FDA.FDA.D.8.r.8b-1 and FDA.FDA.D.8.r.8b-2. | SAF-16952 |
| E2B Validation | Fixed an issue where, if a case with Registration in U.S. had invalid nullFlavors, it passed the FDA.D.1*-3 validation rule. | SAF-16663 |
| E2B Validation | Fixed an issue where Substance TermID and TermID Version always passed the FDA.G.k.2.3.r.2a validation rule. | SAF-16407 |
| E2B Validation | Fixed an issue where the ICH.E.i.7 validation rule was missing at the Case level and Submission level for the EMA E2B(R3) file format. | SAF-18243 |
| E2B Validation | Fixed an issue where a warning was appearing for the ICH.D.7.1.r.6 validation rule when the parent and patient have different Medical History records. | SAF-16352 |
| E2B Validation | Fixed an issue with EMA validation where the EMA.F.r.1-1 validation rule failed when the Reason Omitted field for Test Date was set as Unknown. | SAF-17855 |
| E2B Validation | Fixed an issue with EMA validation where the EMA.C.1.8.1 validation rule passed for a transmission with invalid format. | SAF-17905 |
| E2B Validation | Fixed an issue with VAERS E2B(R3) validation where the FDA.FDA.D.2.1b-2 validation rule failed when a valid decade unit was entered. | SAF-17373 |
| E2B Validation | Fixed an issue with VAERS E2B validation where the Validation Result listed Autopsy Performed as a required field when the Date of Death field was left blank, set to a Reason Omitted, or masked. | SAF-16797 |
| Submissions | Fixed an issue where the E2B R3 top-level acknowledgment message was not generated for inbound multi-case E2B R3 transmissions. | SAF-17389 |
| Submissions | Fixed an issue where the blind protected case narrative was generated in the E2B(R2) submission instead of the updated case narrative. | SAF-17047 |
| Submissions | Fixed an issue where the VAERS Certification Enhancement was not automatically enabled in the initial release of Vault Safety 21R1.0. | SAF-17234 |
| Submissions | Fixed an issue where the Country Obtained field was present in the generated submission file when it was absent in the source file. | SAF-18841 |
| Submissions | Fixed an issue where a VAERS submission was rejected due to the D.7.3 (Concomitant Therapies) value being set to false. | SAF-19911 |
| Submissions | Fixed an issue where the E2B R3 top-level acknowledgment message was not generated for inbound multi-case E2B R3 transmissions. | SAF-17389 |
| Reporting Email Follow-ups | Fixed an issue where the correspondence records were not generated when a combination product is selected on a template questionnaire. | SAF-15991 |
| Email Distributions | Fixed an issue where the system was not populating certain tokens in the created Email Distribution. | SAF-17637 |
| Fixed an issue where an error message that appeared when creating an Email Transmission Profile did not meet the standard format. | SAF-11594 | |
| Gateway Transmissions | Fixed an issue where AS2 gateway communication failed if the name of the incoming E2B file was not specified in the http request. | SAF-18760 |
| Gateway Transmissions | Fixed an issue where asynchronous MDNs were not sent after receiving an ICSR through the AS2 gateway. This resulted in the same ICSR being resent and duplicate AERs being created. A temporary configuration fix was deployed last week for a customer who experienced this issue. This maintenance release deploys a permanent fix for all Safety customers. | SAF-19759 |
| Gateway Transmissions | Fixed an issue where submissions to Health Canada went to Error state due to the encryption certificate not being recognized in Vault Safety. | SAF-17427 |
| Gateway Transmissions | Fixed an issue with MHRA (UK) Submissions where, when the Re-evaluate Submission/Distribution user action was run on a Follow-Up Case, the Case went to Transmission Error State and an error appeared stating the Submission to MHRA could not be created because no transmission profile was found in the populate_transmission_profile__v rule function. | SAF-20546 |
| Transmission Generation | Fixed an issue where the system didn't auto-generate a GUID in the E2B Message ID field for a manually created E2B transmission, which led to the Batch Number field not being populated on the FDA E2B(R2) document. This resulted in a failed submission to the FDA. | SAF-18258 |
| Transmission Generation | Fixed an issue where an empty section was created on the transmission for EMA E2B(R3) when there was no patient menstrual information. | SAF-19565 |
| Transmission Generation | Fixed an issue where an empty section was created on the transmission for EMA E2B(R3) when there was no study data. | SAF-19566 |
System
| Category | Description | Issue Number |
|---|---|---|
| Lifecycles & Workflows | Fixed an issue where, when a user selected "Re-evaluate Submission/Distribution" and completed the transmission error task on the generated submission record, the system skipped the current workflow and moved the Case to the next workflow. | SAF-16857 |
| Security | Fixed an issue where a user could successfully view Dose form and RoA Object IDs on an Inbox Item when their Object permissions for these forms was disabled. | SAF-16552 |
| Security | Fixed an issue where a console error appeared if a user without 'Read' permission for Gender Controlled Variables tried to view the Patient section on an Inbox Item. | SAF-16544 |
| Security | Fixed an issue where a user could successfully edit the Age Group field on an Inbox Item when their permissions for Age Group Controlled Variables was disabled. | SAF-16547 |
| UI/UX | Fixed an issue where there was a large amount of spacing between rows on the Potential Matches page after promoting Inbox Item or AER to Case. | SAF-18447 |
| UI/UX | Fixed an issue where, after modifying the reported MedDRA term, the strikethrough was in the wrong position and did not strike the coded term. | SAF-17019 |
| UI/UX | Fixed an issue where there was extra padding on the Potential Match screen for Firefox browsers. | SAF-16463 |
| UI/UX | Fixed an issue where there was no spacing between the narrative translation and lanuage on the narrative text for E2B(R2) export. | SAF-17997 |
Safety.AI
The following Vault Safety.AI issues are fixed in 21R2.
Intake
| Category | Description | Issue Number |
|---|---|---|
| Case Promotion | Fixed an issue where a second Case Contact Record for an Inbox Item was created after Case Promotion. | SAF-16653 |
| Verification | Fixed an issue where, after selecting Show More on the Source Data pane, the header is not displayed on the pop-up for the Patient, Detail, and Custom sections. | SAF-16368 |
| Verification | Fixed an issue where a server error appeared after saving a new Product with Patient ROA information on an Inbox Item. | SAF-19686 |
| Verification | Fixed an issue where, when the Drug Role field was set to Similar Device, "null" appeared in the Product header. | SAF-18490 |
Case Processing
| Category | Description | Issue Number |
|---|---|---|
| Data Entry | Fixed an issue where if the Patient section was collapsed, after verifying the Date of Death validation error ("The date cannot be later than the Date of Death"), the user could not save the section and the error persisted. | SAF-18038 |
System
| Category | Description | Issue Number |
|---|---|---|
| Audit Log | Fixed an issue where encrypted Inbox Item field values were not shown in the audit trail. | SAF-17847 |
| UI/UX | Fixed an issue where the translation for the invalid_patient_section_exceeds_limits__v error has an extra "n". | SAF-14548 |
| UI/UX | Fixed an issue where there was a blank option in the Study Arm field dropdown. | SAF-16817 |
| UI/UX | Fixed an issue where there was a blank option in the Report Type field dropdown. | SAF-17296 |
| UI/UX | Fixed an issue where, after changing the vault language, the translatated 'New' icon did not adjust its size on the Inbox Item sections. | SAF-17379 |
