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 24R2 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 24R2.0, so our maintenance releases for this version are 24R2.0.2, 24R2.0.3, 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 24R2 Maintenance Releases.
Last Updated: November 12, 2024
November 12, 2024
Release Number: 24R2.0.13 | Build Number: 290
| Description |
Issue No. |
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Vault includes inactive MedDRA terms when synchronizing terms from a Standard MedDRA Query (SMQ) to a Datasheet or Watchlist. With this release, Vault Safety copies SMQ terms that match the Datasheet or Watchlist MedDRA version.
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SAF-58687 |
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If the Registration Type reporting rule parameter is populated on a Safety Rule Set, Vault does not generate Submissions to the PMDA for cross reporting scenarios.
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SAF-64461 |
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When both an initial and follow-up Case for Japan are created through XML import or both are created manually, Vault does not generate Localized Case Assessments for any new Adverse Events on the follow-up Case.
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SAF-64868 |
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When evaluating Investigational to Investigational cross-agency cross reporting scenarios for the PMDA, Vault considers Japan Study Registrations, instead of Japan Investigational Product Registrations, on the related non-Japan Study Registration. This leads to the under-reporting of Cases to the PMDA.
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SAF-64870 |
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When using the Inbox Item to Case Compare page to promote an Inbox Item to a follow-up for a Case created through the Safety-EDC Connection, Vault does not identify matching Medical History & Concurrent Conditions type Medical Event records, leading to duplicate records on the follow-up Case.
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SAF-65146 |
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When promoting an Inbox Item with a blinded Product as a follow-up to an unblinded Japan Domestic Case, Vault displays an error message and Inbox Item promotion fails.
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SAF-66744 |
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After the Evaluate Reporting Obligations action runs on a global Case, Vault maps the Narrative Preview and Narrative Length values to the Localized Case.
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SAF-66876 |
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When users add a Product to an Inbox Item through the Product Browser, after Case promotion, Vault does not populate the MPID version from the active WHODrug dictionary on the Case Product.
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SAF-66957 |
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Vault exports Localized Case Adverse Events with the Special Adverse Event field set to Non-reportable Event to PMDA E2B(R3) files, resulting in invalid files.
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SAF-67480 |
November 5, 2024 (Postponed) November 6, 2024
Release Number: 24R2.0.12 | Build Number: 277
| Description |
Issue No. |
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This update optimizes code for identifying Case children records, such as Case Adverse Event and Case Product, across Case versions. This will be available for configuration in a future release.
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SAF-65654 |
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When Inbox Items are merged to in-flight Cases or promoted to follow-up Cases, Vault does not map Parent Information from the global Case to the Localized Case.
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SAF-67521 |
October 22, 2024
Release Number: 24R2.0.11 | Build Number: 265
| Description |
Issue No. |
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When generating PMDA E2B(R3) reports, Vault exports the J2.15.r Country of publication and J2.17.r Classification of trial/research data elements when they should be excluded based on the PMDA Reporting Category.
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SAF-62583 |
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On PMDA Post-Market aggregate reports, Vault suppresses Submissions for Japan domestic Cases on which the Suppress Submission checkbox is clear.
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SAF-66084 |
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For blinded Case Assessments on E2B-imported Cases, Vault does not roll up Expected values.
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SAF-66427 |
MedDRA terms with apostrophes cannot be auto-coded. In Vaults that are not configured to offer MedDRA coding suggestions (Admins have not enabled Smart MedDRA Coding), MedDRA terms with apostrophes cannot be auto-coded.
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SAF-66428 |
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In Vaults configured to isolate blinded product information for clinical trial study Cases, Vault does not roll up Case Assessment Tags to Case Tags.
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SAF-66429 |
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After receiving an ACK from the PMDA through the AS2 Connection, Vault populates the incorrect Destination Case ID on Local Reporting Details records.
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SAF-66430 |
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PMDA E2B(R3) reports include Section D when the PMDA Reporting Category is Safety Measure or Research Report.
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SAF-66431 |
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When both the "Enable Localization-based Mapping on Import" and "Enable auto-set Inbox Item Localization by Reporter Country" settings are enabled, Vault displays an error message when promoting an Inbox Item with a Combination Product that includes multiple product constituents to a Case through the Inbox Item to Case Compare page.
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SAF-66505 |
October 15, 2024
Release Number: 24R2.0.10 | Build Number: 255
| Description |
Issue No. |
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When a Case Reporter Qualification is Unknown, Vault exports the UNK nullFlavor to the C.2.r.4 Qualification data element of E2B(R3) reports without the code system.
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SAF-63050 |
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When attempting to auto-code imported Products to library Product Aliases using the Default Alias field, Vault codes Products without a Default Alias configured.
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SAF-63191 |
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When evaluating reporting obligations, Vault does not correctly consider Inbound Transmissions when generating One Last Time (OLT) reports for destinations, even if they are configured to prevent back reporting.
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SAF-63743 |
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When importing E2B formats through the AS2 Gateway, if the file format is not specified in the header, Vault sets the Intake Format to "Document" instead of "E2B".
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SAF-64266 |
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When creating a follow-up Case for a Japan domestic Case with multiple Local Reporting Details records through the Inbox Item to Case Compare page, Vault replaces the Case Product Registration on all Local Reporting Details records with the primary Case Product Registration.
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SAF-64294 |
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When a Vault's Auto-Translation Framework uses a custom translation service integration, the Cancel Translation Request action is not available.
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SAF-65229 |
October 8, 2024
Release Number: 24R2.0.9 | Build Number: 241
| Description |
Issue No. |
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When adding Company Products to Inbox Items and Cases, the Product Browser displays Product matches for the reported Product only if Vault does not find a Product Registration match.
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SAF-58795 |
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When an unblinded Study Case with multiple products is exported to an E2B file, the values of the G.k.2.3.r.1 Substance / Specified Substance Name data element are mapped incorrectly.
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SAF-62323 |
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For Vaults configured to isolate blinded product information on clinical trial study Cases, when promoting an Inbox Item to a follow-up Case, Vault displays an error message if a record is ignored or deleted on the Inbox Item to Case Compare page.
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SAF-64177 |
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When a Case Identifier is manually entered and then deleted from an Inbox Item, Vault no longer matches using any available ID during duplicate detection.
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SAF-64264 |
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Vaults configured with any time zone ahead of Greenwich Mean Time (GMT) cannot generate PSMF PDFs.
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SAF-64654 |
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When users set up in a User Access Group Assignment record with a specified country click Compare Details on the Potential Matches page, Vault displays an error message.
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SAF-64712 |
AS2 Connections cannot process binary or unreadable characters inside an MDN. Vault does not move rule engine-created Submissions resulting from the Void Case action to a Deleted state type.
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SAF-64714 |
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After running the Copy Record action on a Case child record, Vault copies the Compare ID to the new record instead of generating a new ID.
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SAF-64913 |
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Vault cannot promote E2B-imported Inbox Items with very large volumes of suspect Case Products to new Cases.
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SAF-65147 |
October 1, 2024
Release Number: 24R2.0.8 | Build Number: 225
| Description |
Issue No. |
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If the reported product changes between the initial and follow-up Case versions, Vault displays an authorization error when non-Vault Owner users run the Evaluate Reporting Obligations action on Localized Cases.
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SAF-56193 |
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This update optimizes code for generating expectedness based on Datasheets for blinded Study Products. This will be available for configuration in a future release.
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SAF-62577 |
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After sending a gateway transmission, Vault does not receive ACKs that are UTF-16 encoded.
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SAF-62673 |
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Validation fails when a case contact's email address includes special characters other than single or double quotes.
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SAF-63549 |
Case Processors without the required role permissions can edit Cases in the Promoted state that were created from E2B-imported Inbox Items. Case Processors without the required role permissions can edit Inbox Items in the Promoted state that were created from E2B-imported Inbox Items.
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SAF-64173 |
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AS2 Connections cannot process binary or unreadable characters inside an MDN.
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SAF-64262 |
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When receiving EMA gateway ACKs, if the root value precedes the extension value in the XML file, Vault does not populate the Destination ID value on Transmissions.
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SAF-64597 |
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This update optimizes code for aggregate reports to support product registration detail selection when generating Submissions. This will be available for configuration in a future release.
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SAF-64800 |
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Due to a caching issue, in some instances, Vault uses the incorrect template when sending follow-up correspondence to case reporters.
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SAF-64923 |
September 17, 2024
Release Number: 24R2.0.6 | Build Number: 209
| Description |
Issue No. |
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In some instances, users may experience performance issues when promoting a Case due to inefficient DME Watchlist evaluation and caching.
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SAF-61572 |
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When creating a Japan domestic follow-up Case, Vault does not copy the value in the System Generated LRD Category field of the Local Reporting Details section of the previous Japan Localized Case version to the follow-up Japan Localized Case. This can result in Vault generating unnecessary Local Reporting Details and Submissions after users run the Generate Local Reporting Details action.
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SAF-62322 |
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PMDA E2B(R3) reports include Section D for all PMDA Reporting Categories.
This fix has been moved to a future release.
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SAF-62533 |
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In the EMA ICSR Reporting Rule Set, the Study Type parameter on the Downgrade to Non-Serious rule is configured for "Other Studies" instead of "Other Study".
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SAF-62535 |
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The AE in Jurisdiction Source reporting rule parameter is case-sensitive.
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SAF-62775 |
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Vault cannot evaluate custom Validation Criteria that contain single quotes.
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SAF-63569 |
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If a global Case has multiple Localized Cases, when generating Case Product Registration records on a related Japan Localized Case, Vault does not populate the Due in Days field.
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SAF-63610 |
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When evaluating a Case with custom Validation Criteria, if the Local Expedited Criteria field is blank on a Transmission for a previous Case version and there is a One Last Time reporting rule set to "Same as Previous" for the related Inbound Transmission origin, Vault sets the new Transmission record to the Validation Error state.
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SAF-63874 |
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After merging a PSMF binder to a PDF, Vault does not apply the configured sharing rules.
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SAF-64105 |
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Vault does not include the Case Checklist Rule Assignment, Checklist Creation Rule, and Checklist Creation Rule Criteria objects in audit trails by default.
This fix has been moved to a future release.
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SAF-64743 |
September 10, 2024
Release Number: 24R2.0.5 | Build Number: 197
| Description |
Issue No. |
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After receiving an ACK response to a gateway submission, Vault does not populate the ACK.B.r.2 Local Report Number in the Destination Case ID field of the associated Transmission record.
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SAF-60483 |
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This update optimizes code for syncing global and localized follow-up cases. This will be available for configuration in a future release.
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SAF-61855 |
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This update optimizes code for syncing global and localized case narratives. This will be available for configuration in a future release.
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SAF-61873 |
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Transmission Output Templates do not generate multiple submissions to the same agency or multiple distributions to the same partner. If the due date is not less than the rule's Due Date, Vault ignores the applicable Transmission Profile.
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SAF-62361 |
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This update optimizes the Vault Safety reporting rule engine in preparation for case reportability classifications. This will be available for configuration in a future release.
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SAF-62662 |
August 27, 2024
Release Number: 24R2.0.4 | Build Number: 186
| Description |
Issue No. |
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In some cases, users receive an error when merging to an in-flight Case if the Inbox Items were created using the Safety-EDC Vault Connection.
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SAF-62113 |
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In Vaults with the Clinical Trials: Isolate Blinded Product Information enabled, some entry actions may not execute on Study Cases and Vault displays a system error message.
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SAF-63012 |
August 18, 2024
Release Number: 24R2.0.3 | Build Number: 181
| Description |
Issue No. |
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In some situations, when a PMDA localized case does not yet exist on the global case but validations are run, customers may experience an unexpected validation criteria failure for PMDA submittable cases.
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SAF-63392 |
August 16, 2024
Release Number: 24R2.0.2 | Build Number: 179
| Description |
Issue No. |
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Following reporting rule evaluation on Follow-up Cases with multiple PMDA cross reporting obligations, Vault displays an error message and prevents some actions, such as generating Transmissions or calculating due dates.
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SAF-63127 |