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.
This list only covers fixes for issues that impact 24R3 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 24R3.0, so our maintenance releases for this version are 24R3.0.2, 24R3.0.3, 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 24R3 Maintenance Releases.
| Description |
Issue No. |
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On Japan domestic Cases with one (1) Study Product and no Datasheet, if a user manually enters an Expected value on the Localized Case Assessment and then manually enters an Expected value on the Case Assessment, Vault sets the Expected (Status) field to "Auto Calculated" instead of "Overridden".
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SAF-58838 |
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In some instances, when a user attempts to delete a Case Assessment from the Assessment grid while Vault is reevaluating and generating Case Assessments, Vault displays an error message and cannot delete or display the record.
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SAF-70033 |
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In Vaults configured with the "Enable Localization-based Mapping on Import" application setting, when importing a domestic Case for a Localization with a specified Localization Scope and the source document includes out-of-scope field values, global values do not appear in the related dual-entry domestic Case fields, requiring users to enter missing values manually.
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SAF-71242 |
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For Cases reportable to the PMDA, Vault maps global Case Assessment Expectedness values to all Localized Case Assessment Expectedness records.
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SAF-72211 |
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During E2B import, when executing custom SDK code, in some instances Vault does not process all Case Assessments, which prevents completing the import.
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SAF-73065 |
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When generating PMDA E2B(R3) reports for Cases created with migrated data, if the Patient RoA TermID and Patient RoA TermID Version values are blank on Case Product Dosage records, Vault exports "2.0" as the CodeSystemVersion for the G.k.4.r.10.2b data element, instead of "2.2", resulting in Submissions being rejected by the PMDA.
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SAF-73194 |
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In some instances, when a user deletes a Case Product while Vault is reevaluating and generating Case Assessments on an initial Case, Vault prevents creating a follow-up Case.
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SAF-73326 |
For a Case related to a Study with both biologics and drugs where the Case includes either a biologic or a drug but not both, Vault does not select the correct Transmission Profile when generating FDA E2B(R3) reports.
Optionally, for clinical trial study Case submissions with no Transmission Profile specified on the Study Registration, you can now configure your Vault to always use the CBER Study Transmission Profile when the Study Product Type is Biologic and the CDER Study Transmission Profile for any other Study Product Type. For more information, contact Veeva Support.
Enablement: Support
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SAF-73458 |
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When generating FDA E2B(R3) reports for premarket Cases, Vault populates the G.k.9.i.2.r section for non-sponsor Case Assessment Results.
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SAF-73645 |
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For postmarket Cases for Studies configured with the Study Has Unspecified Products setting, Vault does not generate expected manual correspondence that uses the AESI Questionnaire (Template) document type.
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SAF-73773 |
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In Vaults configured to isolate blinded clinical trial information, after users run the Create Follow Up Case action, Vault populates the Blinded Reference ID on unblinded Case Assessment Expectedness records, which prevents follow-up Case creation.
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SAF-74110 |
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When users code a MedDRA Preferred Term (PT) that has undergone a hierarchical change across dictionary versions through the MedDRA Browser, if duplicate records exist for the term in the MedDRA dictionary in the Business Admin library, Vault adds the dictionary version to the non-primary PT.
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SAF-74161 |
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In Vaults configured to isolate blinded clinical trial information, when processing a follow-up with a new adverse event or product to an unblinded Case, Vault prevents entering blind-sensitive information on blinded records, resulting in missing values on blinded Distributions to partners and ethics committees.
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SAF-74746 |
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When generating FDA E2B(R3) reports for study Cases where the study is unblinded and the unblinded Case Product does not have the Rank set to 1, Vault does not order suspect Case Products before Case Products with other drug roles in the G.k section of the report.
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SAF-75033 |
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When generating PMDA E2B(R3) reports for Cases created with migrated data, if the Parent RoA TermID and Parent RoA TermID Version values are blank on Case Product Dosage records, Vault does not export a CodeSystemVersion for the G.k.4.r.11.2b data element, instead of exporting "2.2", resulting in Submissions being rejected by the PMDA.
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SAF-75095 |
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In Vaults configured with the "Cross Reporting without Datasheet Expectedness Substitution" application setting, when evaluating cross reporting obligations for study Cases, Vault generates Case Assessment Expectedness for all Study Products that have a common Datasheet to the Study Product on the evaluated Case Assessment, instead of only Study Products with the same Substance.
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SAF-75304 |
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When generating FDA E2B(R3) files with a value in the F.r.3.1 Test Result (code) data element, Vault exports the F.r.3.2 Test Result (value / qualifier) data element tag but does not export existing values in the Test Result (Qualifier) and (Number) fields on the Case Test Result.
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SAF-75672 |
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When generating FDA E2B(R3) reports for cross reporting obligations for studies not registered in the United States, Vault does not map a Study Registration Number to the "FDA.C.5.5a IND Number where AE Occurred" data element.
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SAF-75896 |
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When generating FDA E3B(R3) reports, if an unsupported Unified Code for Units of Measure (UCUM) code exists in the Strength (Unit) field of the Case Product Substance, the Dose (unit) field of the Case Product Dosage, or the Cumulative Dose (unit) field of the Case Product record, Vault exports tags with no values to the G.k.2.3.r.3a, G.k.2.3.r.3b, G.k.4.r.1a, G.k.4.r.1b, G.k.5a, and G.k.5b number and unit data elements.
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SAF-76115 |
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In Vaults configured to isolate blinded clinical trial information, Vault does not support commas in cell values of CSV files prepared for bulk unblinding Cases.
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SAF-76309 |
| Description |
Issue No. |
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When using multilingual MedDRA with either NLD (Dutch; Flemish) or SPA (Spanish; Castilian) as the language, after autocoding a MedDRA term, Vault creates duplicate MedDRA (Localized) records with blank Language fields.
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SAF-69442 |
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When searching for a JDrug code in the JDrug Browser, if the search term includes any alphabetic characters, no search results appear.
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SAF-69444 |
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For Inbox Items generated from the Safety-EDC Vault Connection, subject information for patient height history, weight history, last menstruations, and pregnancy information does not reflect the onset date of the primary adverse event.
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SAF-72080 |
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In Vaults configured to isolate blinded clinical trial information, when evaluating expectedness for general reporting, the reporting rules engine does not evaluate expectedness for Study Products using study product Datasheets but instead uses product core Datasheets.
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SAF-73774 |
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When a user removes a Case Assessment on a Japan domestic Case and then runs the Generate Assessments action, Vault generates a duplicate of existing Localized Case Assessments on the Localized Case.
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SAF-74058 |
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In Vaults with MedDRA Criteria records created before Vault introduced the Standard MedDRA Query (SMQ) Hierarchy Update feature in 24R1, after a MedDRA dictionary version update, those records remain linked to non-primary SOC MedDRA terms.
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SAF-74149 |
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When using study product Datasheets, after running the Re-evaluate Submissions / Distributions action on a study Case, Vault does not always correctly evaluate reporting obligations based on the expectedness for the passing Case Assessment. In some instances, Vault evaluates reporting obligations using a different Case Assessment based on a Study Product set up with a study product Datasheet and Study Product Placeholder, resulting in an incorrect expectedness determination.
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SAF-74208 |
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Vault exports MPIDs, instead of NDC codes, to the D.8.r.2b, D.10.8.r.2b, G.k.2.1.1b, and FDA.G2.k.2b data elements of FDA VAERS E2B(R3) reports, resulting in NACKs from the FDA.
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SAF-74439 |
| Description |
Issue No. |
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In some instances, Vault codes Localized MedDRA terms in English instead of the local language.
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SAF-69438 |
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When the Generate Assessments action is running as part of a workflow and another workflow to reset the Locked By field runs, when the Generate Assessments action finishes, Vault locks the Case to the initial user instead of the current user.
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SAF-70626 |
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If Case Assessment Result controlled vocabulary labels are changed from the Vault-provided values, when generating MFDS E2B(R3) reports for domestic study Cases, Vault does not populate the G.k.9.i.2.r.3.KR.2 KRCT Result of Assessment data element.
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SAF-71663 |
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For follow-up online questionnaires configured with Question Field Mapping for the Event Country of the (Primary) Case Adverse Event, when respondents access and submit questionnaires that include a country name through public access links (PALs), Vault maps the country ID instead of the name and displays an error when users attempt to open the generated Inbox Item.
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SAF-72076 |
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On generated MFDS E2B(R3) reports, Vault formats the G.k.2.1.KR.1b Medicinal Product ID and G.k.2.3.r.1.KR.1b Substance ID data elements incorrectly.
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SAF-72324 |
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When transmitting custom E2B formats to the Therapeutic Goods Administration (TGA) of Australia, file names sometimes exceed the character limit, resulting in NACKs.
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SAF-72623 |
| Description |
Issue No. |
Vault Safety now supports including Transmissions generated by Transmission Output Templates during One Last Time (OLT) reporting for follow-up Cases. For more information, contact Veeva Support.
Enablement: Support
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SAF-69421 |
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In Vaults with the Generate Assessments for both Serious and Non-Serious Adverse Events application setting enabled, when Vault cannot generate Case Assessments during Case promotion, Vault now promotes the Inbox Item and creates the Case with no Case Assessments. This enables users to run the Generate Assessments action on the Case to generate Case Assessments, Case Assessment Results, and Case Assessment Expectedness records for Case Adverse Event and Case Product pairs. Previously, when Vault could not generate Case Assessments during Case promotion, Vault did not promote the Inbox Item and voided the Case.
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SAF-69688 |
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When the Superseded By field on a MedDRA term is updated by users coding a MedDRA term on a Case, whether through auto-coding or the MedDRA Browser, the audit trail now includes a clear event description about why Vault updated the Superseded By field.
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SAF-72061 |
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This release improves the performance of auto-coding multilingual MedDRA terms during Inbox Item intake and Case promotion.
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SAF-72067 |
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Vault evaluates Localized Case Assessment Expectedness for Study Products with a Study Product Role of Investigational or Comparator, instead of for any Study Product Role.
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SAF-60246 |
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If the Data Entry (Initial) state of the Case Lifecycle object lifecycle is configured with an entry action that transitions Narrative documents to a different state, after successful Case promotion, Vault does not update the state of localized Inbox Items to Promoted.
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SAF-66949 |
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When generating FDA VAERS E2B(R3) reports for Cases with blank Date of Birth, Age at Vaccination, Age, Gestation, and Age Group values, Vault generates the XML with no D.2 Age Information section values, instead of exporting the nullFlavor NI to the D.2.3 Patient Age Group (as per reporter) data element.
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SAF-71107 |
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When generating FDA VAERS E2B(R3) reports, Vault does not populate the G.k.2.2 Medicinal Product Name as Reported by the Primary Source data element for Case Products with Similar Device in the Drug Role field, resulting in NACKs.
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SAF-71360 |
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When Transmissions that reference the CBER or CDER Transmission Profile are sent to the FDA through the FDA AS2 Connection, Vault names attachment files with the name of the E2B file, instead of the attachment file name.
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SAF-71524 |
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When users run the Copy Case action on a Japan Domestic Case, Vault links copied Case Product Registration records to the original Localized Case instead of the copied Localized Case.
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SAF-71875 |
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When auto-coding MedDRA terms on Cases referencing MedDRA dictionary versions that are older than the latest available version, for terms with Name changes only, Vault creates a new MedDRA term record instead of updating the Name on the existing record.
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SAF-72069 |
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When creating a follow-up Case for a Case with multiple previous versions that include Case Child Information records, Vault copies Case Child Information records from every Case version instead of just the previous Case version, resulting in duplicate records on the follow-up Case.
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SAF-72083 |
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When generating FDA E2B(R3) and FDA VAERS E2B(R3) reports for Cases with a Combination Product that has the Drug Role field set to Suspect and another Combination Product that has the Drug Role field set to Similar Device, for the Similar Device product Vault populates 5 in the G.k.1 Characterisation of Drug Role data element, instead of 4 for Drug Not Administered.
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SAF-72108 |
| Description |
Issue No. |
Vault Safety now supports masking exceptions when reporting to Swissmedic. If Mask PII is configured on a Transmission, when exporting an EMA E2B(R3) with a transmission destination of Swissmedic, Vault will not mask the following Case fields:
- Date of Death
- Last Menstrual Period (Patient or Parent)
- Medical History Text
- Sex (Patient or Parent)
If the field contains a manually entered MSK value, then the field is omitted from the transmission.
Enablement: Auto-on
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SAF-71031 |
Vault Safety now supports evaluating expectedness based on Study Product Datasheets for Study Products with any Study Product Role. Previously, Vault generated expectedness only for Study Products with a Study Product Role of Investigational.
Enablement: Auto-on
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SAF-71094 |
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After promoting an Inbox Item with new adverse events as a follow-up through the Inbox Item to Case Compare page, when syncing data from the global Case to a Japan Localized Case, Case Assessments and Case Assessment Results are not synced.
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SAF-67979 |
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When users manually delete products or adverse events referenced in assessments on E2B-imported Inbox Items, after domestic Case promotion Vault does not generate all expected Localized Case child records.
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SAF-68167 |
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For E2B-imported Inbox Items with follow-up information that generates new assessments for an existing Japan domestic Case, after merging to the in-flight Case, Vault does not generate all expected Localized Case Assessment Result records based on the global Case Assessment Result records.
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SAF-68710 |
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Generated FDA E2B(R3) files for postmarket reports do not include EDQM terms for the G.k.4.r.9.2a, G.k.4.r.9.2b, G.k.4.r.10.2a, and G.k.4.r.10.2b data elements.
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SAF-68929 |
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In some instances, Vault does not display some Case fields to users with view-only access.
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SAF-70179 |
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In Vaults configured to isolate blinded clinical trial information, when users run the Evaluate Reporting Obligations action on a Localized Case related to a Localized Case for a different locale that has a blinded and unblinded Localized Case Assessment record pair, an error message appears.
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SAF-70982 |
| Description |
Issue No. |
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Vault does not export standalone devices with a Drug Role of "Similar Device" and a Device Report Type of "Malfunction" to FDA VAERS E2B(R3) reports.
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SAF-68653 |
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On the Inbox Item to Case Compare page, when either the Inbox Item or the Case includes Parent Information records and the user manually matches any records, updates page filtering, or switches pages, Vault displays the Parent Information records in the Case Drug History or Case Medical History & Concurrent Conditions sections and prevents merging the Inbox Item to an in-flight Case.
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SAF-68953 |
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In some cases after running the Copy Case action, Vault copies the version of the copied Case to the generated record instead of creating the new record in v0.1.
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SAF-69153 |
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Vault does not copy the Compare ID field value to Study Registrations for follow-up Cases.
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SAF-69407 |
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For Vaults configured to use Case Access Group security, users in the All Access Group who have a value in the Localization field of their User Access Group Assignment record can see all Localized Cases instead of just those for the specified Localization.
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SAF-69440 |
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When generating PMDA E2B(R3) reports, Vault populates the J2.14 Expectedness data element based on the Localized Case Assessment with the earliest creation date instead of from the Localized Case Assessment related to the primary PMDA product.
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SAF-69441 |
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In some cases when users run the Run Bulk Unblind action on a blinded Case with an unblinded Product and at least one (1) blinded Product, Vault generates another unblinded Product record.
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SAF-69443 |
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In instances where a One Last Time report to the PMDA exists on a Case and the follow-up Case would generate reports only for investigational to investigational cross reporting scenarios, after a user runs the Evaluate Reporting Obligations action on the follow-up Case, Vault does not generate the expected PMDA Transmissions.
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SAF-69867 |
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For Cases created from Literature Articles in Vault SafetyDocs, when generating non-PMDA E2B(R3) reports, Vault maps the value in the Vancouver Citation field instead of the Vancouver Citation (English) field to the Literature Reference(s) data elements, C.4.r.1 for E2B(R3) formats and A.2.2 for E2B(R2) formats, resulting in negative acknowledgments (ACKs).
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SAF-69944 |
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PSMF PDF creation fails for users without the required permissions to create PSMF PDFs.
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SAF-70069 |
| Description |
Issue No. |
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When sending follow-up email questionnaires to Case Reporters, in some instances, Vault sends emails without attaching the questionnaire documents from the Correspondence record.
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SAF-67811 |
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For Cases that include multiple Products with the same Case Product Registration and at least one (1) Local Reporting Details record that references the Case Product Registration in the Primary Case Product Registration field, Vault prevents creating follow-up Cases from Inbox Items.
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SAF-68648 |
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In some instances, system performance issues result in Vault not generating Correspondence when expected. In these instances, Vault appears to generate Correspondence but displays an error message when users try to access the document from the Correspondence record.
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SAF-69354 |
This fix addresses the following previously reported issues affecting the August 2024 version of the FDA MedWatch 3500A form: SAF-68232, SAF-69013, SAF-69014, SAF-69015, SAF-69101.
This fix addresses the following previously reported issues affecting the FDA MedWatch 3500A: August 2024 Version feature: SAF-68232, SAF-69013, SAF-69014, SAF-69015, SAF-69101.
Removed because specific details for each previously known issue is provided in the following rows.
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SAF-69760 |
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When the Gender field on a Case is blank, Vault automatically selects the "Decline to answer" checkbox on the generated MedWatch 3500A form.
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SAF-68232 |
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When the Sex field on a Case is blank, Vault automatically selects the "Decline to answer" checkbox on the generated MedWatch 3500A form.
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SAF-69013 |
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Generated MedWatch 3500A forms include the Concomitant Medical Products and Therapy Dates section for non-device Cases.
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SAF-69014 |
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Section B in generated MedWatch 3500A forms includes repeated Relevant Tests/Laboratory Data, Including Dates details.
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SAF-69015 |
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Overflow pages on generated FDA MedWatch 3500A (August 2024 Version) forms display some incorrect labels in the "Treatment Dates/Therapy Dates" and "Diagnosis for use" sections.
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SAF-69101 |