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 24R1 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 24R1.0, so our maintenance releases for this version are 24R1.0.2, 24R1.0.3, 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 24R1 Maintenance Releases.
Last Updated: July 24, 2024
July 23, 2024
Release Number: 24R1.0.13 | Build Number: 282
| Description |
Issue No. |
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When an Inbox Item is promoted to a Follow-up Case or merged to an In-flight Case through the Inbox Item to Case Compare page, if the Reason field on the Inbound Transmission record is "Nullification," Vault overwrites the reason to "Follow-Up".
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SAF-59798 |
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When the Clinical Trials: Isolate Blinded Product Information feature is enabled and a Vault includes a large volume of Case Assessments and related child records, users may experience performance issues when editing Case Assessment Result records.
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SAF-62062 |
July 18, 2024
Release Number: 24R1.0.12 | Build Number: N/A
| Description |
Issue No. |
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If Smart MedDRA Auto-Coding is enabled, Vault removes the stop words "no", "not", and "nor" from the search, which can result in incorrect auto-coding.
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SAF-61584 |
July 16, 2024 (Postponed) July 17, 2024
Release Number: 24R1.0.11 | Build Number: 279 280
| Description |
Issue No. |
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When processing Domestic Cases, if field-level atomic security gives a user Read access on Domestic Cases and Edit access on Localized Cases, both the local and English components of dual-entry fields are read only.
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SAF-58181 |
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On Domestic Cases where Localization has a scope, users without access to the Localized Medical History Text field can't see the Medical History Text box on the global Case, although the Medical History Text Reason Omitted field is displayed.
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SAF-58366 |
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When Suppress Submission is selected on a Case, Vault still generates One Last Time reports.
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SAF-58368 |
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For users with Read permission on Reason Omitted fields, those fields appear editable when in edit mode on Cases, although Vault does not save entered changes.
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SAF-59527 |
July 2, 2024
Release Number: 24R1.0.10 | Build Number: 270
| Description |
Issue No. |
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Vault prevents Follow-up Case creation when the previous Case version includes an Adverse Event linked to a Diagnosis.
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SAF-58266 |
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When exporting custom E2B formats with ICH as the base document type, if a Case is also reportable to another agency with a regional E2B, Case-level validations for the ICH base document type for the custom E2B may not run if regional superseding validation criteria are configured for the regional E2B.
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SAF-58606 |
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Vault prevents creating a Follow-up Case from an Inbox Item if an associated Localized Case has a Localized Case Document record with a value in the Case field.
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SAF-58926 |
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When generating a PMDA E2B(R3) report for a Japan Study Case with no Parent Information, the ICH.D.10.6-1 validation criterion fails at both the Case and Submission levels.
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SAF-59067 |
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When a Domestic Case includes a Case Product with one (1) Dosage record that has no local field values, Vault does not generate the expected Localized Case Product Dosage record.
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SAF-59339 |
During evaluations for Japan Localized Cases where a Case Product Registration and Local Reporting Detail record are blank, Vault incorrectly evaluates the ICH.G.k.2.2 Validation Criteria and sets the Validation Status to "Hard Fail."
This issue was fixed by reverting SAF-59290 in 24R1.0.9.
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SAF-61362 |
June 25, 2024
Release Number: 24R1.0.9 | Build Number: 258
| Description |
Issue No. |
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Users can run the Promote to Multiple Cases action multiple times on the same Inbox Item.
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SAF-57241 |
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Non-Vault Owner users cannot manually create Medical History and Drug History records on Domestic Localized Cases.
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SAF-57312 |
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If a user promotes the same Inbox Item to a Case multiple times in quick succession, Vault creates multiple versions of the Case.
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SAF-57657 |
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During validations for PMDA E2B(R3) reports, Vault does not fail the ICH.F.r.3.1-1 and ICH.F.r.3.2-1 Validation Criteria at the Case level.
This fix was reverted by issue SAF-61362 in 24R1.0.10.
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SAF-59290 |
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When generating E2B(R3) reports, Vault incorrectly populates "nullFlavour" instead of "nullFlavor" in the C.5.3 Sponsor Study Number data element.
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SAF-59857 |
June 13, 2024
Release Number: 24R1.0.8 | Build Number: 248
| Description |
Issue No. |
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When Automated Case Promotion is configured with the Smart or Override merge method, Vault promotes Inbox Items to Follow-ups for Cases in prohibited states.
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SAF-59162 |
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When regenerating FDA MedWatch 3500A and CIOMS I forms, if the Patient Content Protection field is populated, Vault generates new documents instead of upversioning existing ones.
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SAF-59426 |
PSMF logbooks include Summary of Changes values added to minor versions of documents related to prior major versions, instead of just to the current major version.
Draft PSMF logbook entries associated with minor versions associated with a previous major version of documents are not automatically updated to the most recent minor version.
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SAF-59686 |
June 11, 2024
Release Number: 24R1.0.7 | Build Number: 242
| Description |
Issue No. |
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For PMDA Cases, users receive an error when creating a Follow-up Case where multiple Localized Case Assessments are linked to a single global Case Assessment.
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SAF-52027 |
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Localized Follow-up Cases have duplicated Case Product Substance records if the initial Case and Follow-up Case have a record for the same Substance.
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SAF-57784 |
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In some Vaults, the Case object's Device Follow-Up Type (device_multi_followup_type__v) field does not appear.
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SAF-59156 |
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PSMF logbooks include Summary of Changes values added to minor versions of documents related to prior major versions, instead of just to the current major version.
This fix has been moved to a future release.
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SAF-59686 |
June 4, 2024
Release Number: 24R1.0.6 | Build Number: 235
| Description |
Issue No. |
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During Transmission generation, in some instances, Vault generates a new report instead of up-versioning an existing report.
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SAF-59096 |
When evaluating reporting rules with SDK parameters configured, Vault now displays error messages for SDK failures by default. This enables users to take action or contact their Admin to resolve SDK issues. Previously, Vault did not identify SDK failures. Contact Veeva Support to turn off SDK error notifications in your Vault if your organization needs time to address outstanding SDK issues.
Enablement: Auto-On
Default Impact: Visible to All Users
GxP Risk: High
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SAF-59325 |
May 30, 2024
Release Number: 24R1.0.5 | Build Number: 231
| Description |
Issue No. |
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In some instances, Product Registration records cannot be created or edited.
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SAF-57270 |
During duplicate search, Vault considers MRNs as an ID match instead of a Patient record match and, in some instances, marks Inbox Items as Follow-up instead of creating new Cases. When duplicate search finds matching Patient MRN values, Vault tags the search result with "Likely match" instead of "Possible Match" and, when using Automated Case Promotion, Vault marks Inbox Items as Follow-up instead of creating new Cases.
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SAF-59041 |
May 15, 2024
Release Number: 24R1.0.4 | Build Number: 226
| Description |
Issue No. |
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Vault cannot generate or validate custom E2B Transmission formats that use SDK.
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SAF-58847 |
May 14, 2024
Release Number: 24R1.0.3 | Build Number: 223
| Description |
Issue No. |
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For Study Cases with non-Study Products, when the Case enters the Revision state, Vault clears the value in the Case Blinded field of the Details section.
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SAF-55749 |
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When generating FDA MedWatch 3500A forms, if the Rank 1 Case Product is a Device and the Product Registration field of the highest ranked non-Device Product is blank, Vault does not populate the NDA # field in Section G of the form.
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SAF-56220 |
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When creating a Follow-up Case for a Study Case that was kept blinded through the Case workflow, Vault sets the Case Blinded field to No on the Follow-up Case.
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SAF-56783 |
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If Smart MedDRA Coding is enabled, in some instances importing a high volume of Inbox Items causes the Number of Requests in Current Month counter on the MedDRA Coding Settings record to lock and E2B import fails. The Number of Requests in Current Month counter has been turned off and will be fixed in a future release.
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SAF-56801 |
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When Automated Case Promotion is configured with the Override merge method, if an Inbox Item has a matching MRN with a Case, but the Worldwide UID does not match, Vault creates a new Case and changes the Worldwide UID on the original Case.
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SAF-56018,
SAF-57164 |
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Vault does not run Validation Criteria with a Rule Formula Format of Case Data or Case Data - Expression when the Agency field is blank.
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SAF-57779 |
May 7, 2024
Release Number: 24R1.0.2 | Build Number: 212
| Description |
Issue No. |
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When the Safety-EDC Vault Connection is enabled, after creating a serious adverse event (SAE) that includes multiple adverse events (AEs) in a CDMS Vault, when Vault generates an Inbox Item in the connected Safety Vault, Vault does not assign Rank 1 to the primary AE.
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SAF-54230 |
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When the Safety-EDC Vault Connection is enabled, if a user in a CDMS Vault deletes SAE subject data that was previously linked on an Inbox Item in a Safety Vault, Vault maps the deleted subject data when creating an Inbox Item for a Follow-up.
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SAF-55733 |