Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
The following tables list issues fixed for Vault Safety and Vault SafetyDocs in 23R1. For details about fixed issues in the Vault Platform in 23R1, see the Vault Release Notes.
Safety
Vault Safety 23R1 includes the following fixed issues.
Intake
| Category | Description | Issue Number |
|---|---|---|
| Case Promotion | Fixed an issue with copying patient information from an existing Case to a new Case where, when Narratives were copied, additional Narrative documents were generated and prevented Case processing. | SAF-35553 |
| Case Promotion | Fixed an issue where, when promoting an AER to a Case, UID was not included in the Potential Match criteria. | SAF-36803 |
| Case Promotion | Fixed an issue where, when 22R3 deep duplicate detection was enabled, in some instances the Potential Matches page displayed more results than the maximum number configured in Case Promotion Settings. | SAF-36852 |
| Case Promotion | Fixed an issue where, when a Case Product had a Drug Role of "Concomitant" and the related Dosage record had partial dates (for example, YYYY-MM) in the First Admin Date or Last Admin Date fields, the New Case - Copy Patient Information action was prevented. | SAF-36913 |
| Case Promotion | Fixed an issue with merging Inbox Items into in-flight Cases where Case identifiers doubled with each merge. This led to a high number of duplicate records with the potential to impact system performance. | SAF-37300 |
| Case Promotion | Fixed an issue where, when Atomic Security was configured to hide fields with protected health information (PHI) and personally identifiable information (PII), some values still appeared on the Potential Matches page during Case promotion. Now, Vault Safety includes the option to hide all Reporter, Patient, and Adverse Event Onset field values on the Potential Matches page. Enablement: Admin Checkbox Learn More: |
SAF-37499 |
| Case Promotion | Fixed an issue where, when promoting an Inbox Item and merging it into an in-flight Case or creating a Follow-up Case, if a Case child object on either the Inbox Item or the matched Case exceeded the system limit of 300 records, none of the Inbox Item records for that object were applied to the new Case version. Now, the system limit for Case child objects is 500 records. | SAF-37528 |
| Case Promotion | Fixed an issue where, when Strict Case Locking was enabled, after promoting an Inbox Item to multiple Cases only the first created Case entered the Triage lifecycle state. | SAF-37657 |
| Case Promotion | Fixed an issue with Case promotion where, when the Potential Matches page included both likely and possible matches, the possible match results were not ranked in the correct order. | SAF-37847 |
| Case Promotion | Previously, when merging to an in-flight Case or creating a Follow-Up Case, if either the Inbox Item or matched Case included at least one (1) Case child object that exceeded the system limit of 500 records, the action was prevented by the system. Now, Vault Safety supports up to 1,500 Case child objects on a maximum of three (3) objects. Enablement: Support |
SAF-37884 |
| Case Promotion | Fixed an issue with automated Case promotion where, when 22R3 deep duplicate detection was enabled and set to consider Inbox Items, promotion failed when the most likely ID match was an Inbox Item. | SAF-38058 |
| Case Promotion | Fixed an issue with Inbox Item promotion where, when the rank 1 Product or Adverse Event was edited to rank 2, Case Promotion was not prevented by the system although there was no rank 1 Product or Adverse Event. | SAF-38668 |
| Case Promotion | Fixed an issue with Case promotion where, in some instances, the Potential Matches page did not appear and a system error was displayed but the Inbox Item was promoted. | SAF-38785 |
| Case Promotion | Fixed an issue with manually created Inbox Items for unarmed studies where, when the Inbox Item included one Study Product, after promotion all Study Products appeared on the Case. | SAF-39633 |
| Case Promotion | Fixed an issue where, when 22R3 deep duplicate detection was enabled, in some instances Promote to Case was prevented when Inbox Items included the words "and", "not", or "or" in Adverse Event or Product fields. | SAF-40685 |
| Data Entry | Fixed an issue where, when an Inbox Item was edited, the Last Modified Date value was not snapshotted to the Section Last Modified Date field. | SAF-38822 |
| Data Entry | Fixed an issue where, when editing a previously saved Inbox Item, the system prevented saving new data in a blank custom long text field. | SAF-39327 |
| Data Entry | Fixed an issue with Inbox Items where, in some instances, after entering the required details, the Identifiable Patient and Identifiable Reporter fields were not set to Yes. | SAF-40223 |
| Duplicate Detection | Fixed an issue with 22R3 deep duplicate detection where Study Number was included in the ID match criteria, resulting in too many Likely Match suggestions. Now, Study Name and Study Number are included in the Matching Reporter criteria. | SAF-37574 |
| Duplicate Detection | Fixed an issue on the Potential Matches page where, when 22R3 deep duplicate detection was enabled, Case Identifiers were not considered when searching for potential matches. | SAF-39774 |
| Duplicate Detection | Fixed an issue on the Potential Matches page where, when 22R3 deep duplicate detection was enabled, Inbox Item Case Identifiers were not considered during duplicate detection. | SAF-39869 |
| Duplicate Detection | Fixed an issue on the Potential Matches page where, when 22R3 deep duplicate detection was enabled, some Inbox Item Case Identifiers for migrated Cases were not considered during duplicate detection. | SAF-41154 |
| E2B Import | Fixed an issue with E2B import through API transmission where, in some instances, the Retrieve Job Status API call did not return acknowledgments after successful imports. | SAF-34985 |
| E2B Import | Fixed an issue with E2B(R2) import where, when a file included thousands of Cases, in some instances not all Cases were imported successfully. | SAF-35077 |
| E2B Import | Fixed an issue with E2B-imported Cases where the Blinded Name (Placeholder) field on the Case Product record was not populated when the reported name was an exact match for the Blinded name. | SAF-35176 |
| E2B Import | Fixed an issue with E2B import where, when the Auto-select Inbox Item Localization by Reporter Country feature was enabled and an Inbox Item had a Localization Type of Local, the system mapped the Name (Reported) field to the localized field instead of the global field (English). | SAF-35958 |
| E2B Import | Fixed an issue with E2B(R3) import where, when the C.5.2 Study Name data element included more than 1,500 characters, import failed instead of populating the additional characters in the Study Name (Continued) field, as expected. | SAF-36218 |
| E2B Import | Fixed an issue where, if a triage workflow was configured to populate a specified field with a value if that field was blank on intake, when an Inbox Item was created from an E2B file the lifecycle state was updated before the workflow was complete. | SAF-36974 |
| Email Intake | Fixed an issue where, when Inbox Items were created through email intake, the Receipt Date field was populated with the date the email was sent. Now, when Inbox Items are created through email intake, the Receipt Date field is left blank. | SAF-36707 |
| Open Case | Fixed an issue with creating Inbox Items where, when Case Access Group Security was enabled, PII-protected Case Validity and Source fields were not populated if the Inbox Item was created by a user without PII access. | SAF-40887 |
Case Processing
| Category | Description | Issue Number |
|---|---|---|
| Auto-Calculation | Fixed an issue where, when auto-calculation was turned off, Age fields were auto-calculated after Case promotion for Inbox Items created through E2B-import. | SAF-37874 |
| Auto-Calculation | Fixed an issue where, when an Inbox Item was received through an AS2 gateway Transmission and auto-promoted, auto-calculations occurred when the related Transmission Profile had the Auto-Calculation Options field set to "Disable". | SAF-38808 |
| Auto-Expectedness | Fixed an issue where, when Expectedness was overridden at the Case Assessment level on a Study Case for a blinded Study, if the Case was unblinded the overridden value for Case Assessment Expectedness was cleared and Case Assessment (Status) was reset to Auto-calculated. This fix addresses an unexpected behavior change caused by SAF-34161, which has been reverted. | SAF-37392, SAF-40201 |
| Case Assessment | Fixed an issue where, when a primary non-serious adverse event was added to a Case, Case Assessments were not updated. | SAF-31894 |
| Case Assessment | Fixed an issue where, when an Inbox Item was merged to an in-flight Case and the Adverse Event was changed, after the merge the Case Assessment name was not updated, although the Case name and Adverse Event record were updated correctly. | SAF-35938 |
| Case Assessment | Fixed an issue where, when creating a new Case and copying patient information from an existing Case, the system did not generate all of the expected Assessments on the new Case. | SAF-36191 |
| Case Locking | Fixed an issue where, when strict case locking was enabled, Vault Owners were prevented from editing Cases. | SAF-35166 |
| Case Locking | Fixed an issue with Strict Case Locking where, when Assign Due Date was configured as an Entry Action and included in the Case Locking criteria, moving Cases to the Approved state was prevented by the system. | SAF-37656 |
| Data Entry | Fixed an issue where page layout rules with field-level conditions were not immediately executed in the same edit session when a field was part of a control. For example, when a case was promoted for a male patient, and then the Gender field was subsequently changed to Female, the gender-specific fields such as pregnancy information did not appear immediately. | SAF-29964 |
| Data Entry | Fixed an issue where, when a Case included a Company Product with a Product Type of Device and the associated Malfunction field was set to Yes, the Case-level Device Report Type field was not populated with "Malfunction". | SAF-38312 |
| Data Entry | Fixed an issue with Combination Products where, when the Drug Role of one Product constituent was changed, the Drug Role of related constituents was not updated. | SAF-38928 |
| Follow-Ups | Fixed an issue where, when a Case with an External Product had a Localized Case Submission, changing the External Product and its Substance on a Follow-up Case was prevented by the system. | SAF-37129 |
| Follow-Ups | Fixed an issue where, when a Follow-Up Case was created for a Pregnancy Case, Case Test Result records for the 1-, 5-, and 10-minute APGAR scores were added to the Parent Information Case, instead of the Child Information Case. | SAF-39815 |
| Localization | Fixed an issue where global Case data was not synchronized to follow-up foreign Localized Cases when the associated Transmission records were created by rules evaluation. | SAF-36713 |
| Medical Review | Fixed an issue where, when Follow-up Questionnaires were created for Inbox Items without a specified Company Product, the generic product template was not selected for the questionnaire and the questionnaire was not sent. | SAF-35889 |
| Snapshotting | Fixed an issue with intake through E2B or JSON where, when the Safety General Settings "Enable auto-set Inbox Item Localization by Reporter Country" and "Enable Localization-based Mapping on Import" checkboxes were both selected, when Inbox Item localization was Global, the following issues occurred:
|
SAF-39945 |
| Watchlists | Fixed an issue where Watchlist Tags were applied to Cases when the associated Organization was not on the Watchlist record. | SAF-34282 |
| Watchlists | Fixed an issue where, when a Study was set up with Unspecified Products, Watchlist tags were not applied to associated Study Cases. Now, when a Study has Unspecified Products, Watchlist tags are applied to Case Products. | SAF-38355 |
Coding
| Category | Description | Issue Number |
|---|---|---|
| MedDRA | Fixed an issue with Localized Cases where values in the English Event (Reported) field were overridden with MedDRA terms when adverse events were coded through the MedDRA browser. | SAF-36617 |
| MedDRA | Fixed an issue where, when the Upgrade to Latest Version action was run to download the latest MedDRA dictionary version, the MedDRA version number on some Preferred Terms (PTs) was not updated. | SAF-40125 |
| MedDRA | Fixed an issue with MedDRA coding where, in some instances, the Auto-Code button was not available in all expected Case Drug History fields. | SAF-41465 |
| WHODrug | Fixed an issue where, when searching by Preferred Name in the WhoDRUG Browser, generic drugs were not returned in the search results. Now, you can filter on generic drugs by entering "generic:y" in the Search bar. | SAF-31080 |
Report Generation
| Category | Description | Issue Number |
|---|---|---|
| CIOMS I, FDA 3500A | Fixed an issue with CIOMS I and FDA 3500A preview generation for Study Cases without Case blinding, when a blinded Study included open Study Arms, the report data was masked. Now, when a Study Case is not set to be blinded and the blinded Studies included open Study Arms, Vault Safety includes the option to generate unmasked report previews. Enablement: Auto-On Learn More:
|
SAF-35118 |
| CIOMS I, FDA 3500A | Fixed an issue where, when generating reports for Combination Products, Product constituents with a Drug Role of "Similar Device" were included on CIOMS I forms (in section II. Suspect Product(s) Information) and FDA 3500A forms (in section C. Suspect Products or D. Suspect Medical Device). | SAF-38301 |
| CIOMS I, FDA 3500A | Fixed an issue where CIOMS I and FDA 3500A forms failed to generate when Case Result (Text) fields included non-numeric values. | SAF-38302 |
| E2B Export | Fixed an issue with FDA E2B(R2) files where, when there was no patient death or parent information, blank tags were exported for the B.1.9 Patient Death and B.1.10 Parent data elements. | SAF-13587 |
| E2B Export | Fixed an issue where, when Combination Products included more than one (1) device constituent with a lot number, the system did not generate FDA VAERS E2B(R3) files correctly. | SAF-33478 |
| E2B Export | Fixed an issue with generating FDA E2B(R2) files with device-specific adverse events where International Medical Device Regulators Forum (IMDRF) codes for Medical Device Problems and Investigation Conclusions were not exported correctly. | SAF-35844 |
| E2B Export | Fixed an issue with E2B file export where, when a Case with a Combination Product also included a non-Combination Product with a Drug Role of "Similar Device", the Product with the Drug Role of "Similar Device" was exported to all E2B Transmission formats. Now, those Products are exported only to FDA E2B(R2) and FDA VAERS E2B(R3) formats. | SAF-35963 |
| E2B Export | Fixed an issue with E2B export where values in the Study Name (Continued) field were not populated in the C.5.2 Study Name data element of E2B(R3) files. | SAF-36184 |
| E2B Export | Fixed an issue with E2B(R2) file export where, when only a non-primary Case Adverse Event was Serious, the A.1.5.1 Serious data element was set to "No" although the A.1.5.2 Seriousness Criteria was set to "Yes" for the applicable Seriousness Criteria. Now, when any Case Adverse Event includes Seriousness Criteria, the A.1.5.1 data element is set to "Yes". | SAF-36441 |
| E2B Export | Fixed an issue where, when the Cumulative Dose field on the Case Product was missing a unit value, E2B(R2) export failed. | SAF-36989 |
| E2B Export | Fixed an issue with E2B(R3) report generation where the G.k.2.1.1a MPID Version/Date Number data element exceeded 10 characters. Now, the value is exported as YYYYMMDD. The same format is now also applied to the following data elements:
|
SAF-37771 |
| E2B Export | Fixed an issue with FDA E2B(R2) export where, when a Combination Product included Drug and Company Product constituents and the Company Product had a Drug Role of "Similar Device", the Company Product was not included in a B.4 Drug(s) Information block of the file. | SAF-38297 |
| E2B Export | Fixed an issue where, in some instances, Products with a Drug Role of "Similar Device" were exported on FDA VAERS E2B(R3) reports when they should have been excluded. | SAF-38929 |
| E2B Export | Fixed an issue with PMDA E2B(R3) export where the E2B Code was not exported correctly in the J2.13.r.3 Development phase data element. | SAF-39326 |
| E2B Export | Fixed an issue with E2B(R3) file export for Follow-Up Cases where the C.1.8.2 First Sender of This Case data element was populated with the value in the First Sender field of the follow-up Inbound Transmission, instead of the original Inbound Transmission. | SAF-39660 |
| E2B Export | Fixed an issue where invalid E2B files were generated when Case Study Registrations were set up with Country Unknown (2-letter Code "ZZ"). Now, Study Registrations set up with Country Unknown are not downloaded to Cases. | SAF-40941 |
| E2B Export, FDA 3500A |
Fixed an issue where, when the Device Code entered in the Case Product Device Code field was not a level 3 code, the corresponding FDA code was not exported to FDA E2B(R2), FDA VAERS E2B(R3), and FDA 3500A files. | SAF-38235 |
| FDA 3500A | Fixed an issue with FDA 3500A form generation where, when Combination Products included Product constituents with a Drug Role of "Similar Device", the constituents were not exported to overflow pages. Now, Products with a Drug Role of "Similar Device" are exported to overflow pages under the heading "C/D. Similar Device(s)". | SAF-39054 |
Transmissions
| Category | Description | Issue Number |
|---|---|---|
| E2B Validation | Fixed an issue with E2B(R3) validation where the ICH.C.5.1.r.1 data element always required that the Study Registration Number was populated with a valid unique EU trial number or EudraCT number. Now, this validation criteria applies only to Transmissions to the EudraVigilance Clinical Trial Module (EVCTM). | SAF-34818 |
| Email Distributions | Fixed an issue where, when voiding a Case and nullifying all previous Transmissions, the New Info Date token in the message body of email Transmissions was populated based on the previous version of the Transmission. | SAF-38266 |
| Email Transmissions | Fixed an issue where, when sending Submissions and Distributions over email, the full email body was captured in the Initial Message Sent event type of the Email Events Log. This created the potential for personally identifiable information (PII) to appear in the log. | SAF-38460 |
| Reporting Rules | Fixed an issue where, when voiding a Case and generating a Transmission with the One Last Time parameter set to "Yes", the Previously Submitted reporting rule parameter evaluated only the previous Case version. Now, all prior Case versions are evaluated and the Transmission is generated with the One Last Time parameter set to "Yes" only when the most recent Transmission for the same destination has the One Last Time parameter set to "No". | SAF-33974 |
| Reporting Rules | Fixed an issue with generating FDA 3500A forms where the Due in Days calculation was not updated to reflect the Due Date calculation. | SAF-35964 |
| Reporting Rules | Fixed an issue with evaluating the Downgrade reporting rule parameter for Clinical Trial Cases where, when the Safety Rule Set had Product Selection set to "Most Conservative Product", the most conservative product on the original Case was not considered. Now, the most conservative product on both the original and Follow-up Case is evaluated to determine if the Clinical Trial Case's seriousness, expectedness, and relatedness have been downgraded or upgraded. | SAF-36440 |
| Reporting Rules | Fixed an issue where it was not possible to enter "--" in Reporting Rule Parameter fields to indicate that a parameter should not be inherited from the parent Rule Set. | SAF-36853 |
| Reporting Rules | Fixed an issue with rule parameter evaluation for AE in Jurisdiction where, when the Primary Reporter Country field was blank, the system did not fall back to the Adverse Event country, resulting in under-reporting. | SAF-36865 |
| Submissions/Distributions | Fixed an issue with manual Submission and Distribution creation where, when a Transmission Profile was selected, the system did not apply some settings to the Submission or Distribution record. Now, the following Transmission Profile settings are applied to the record:
Enablement: Support |
SAF-36734 |
| Submissions/Distributions | Fixed an issue where, when a Transmission was created manually and then the Transmission Document Type was later changed to E2B, the E2B Message ID was not generated. | SAF-36831 |
| Submissions/Distributions | Fixed an issue where, when a Custom Rule Set did not have the Agency set to "PMDA" and a Case Product Registration did not have the Country set to "Japan", expected Distributions for the PMDA were not generated. | SAF-37856 |
| Transmission Generation | Fixed an issue where, when voiding localized Follow-up Cases, generated Transmission records linked to the original Localized Case, instead of the Follow-up Case. | SAF-36554 |
| Transmission Generation | Fixed an issue where Products with a Drug Role of "Similar Device" were being included on non-FDA Transmission documents. | SAF-38225 |
| Validation Rules | Fixed an issue where, when the value in the Case Test Result (Unit) field did not comply with the EMA Unified Code of Units of Measure (UCUM) list, the Submit to Gateway action was not prevented, resulting in Negative Acknowledgement (NACK) messages. | SAF-36122 |
Aggregate Reporting
| Category | Description | Issue Number |
|---|---|---|
| PADER | Fixed an issue where Cases did not appear on PADER 15-Day and Non-15 Day Summary Reports due to page count limitations. | SAF-34380 |
System
| Category | Description | Issue Number |
|---|---|---|
| Audit Log | Fixed an issue where, when promoting an Inbox Item, the audit trail did not log Potential Matches search results if the Create New Case, Mark as Duplicate, Mark as Follow-Up, or Create Follow-Up actions were used. | SAF-34932, SAF-36564 |
| Lifecycles & Workflows | Fixed an issue where non-Vault Owners could not void Cases in the Approved state. | SAF-35534 |
| Lifecycles & Workflows | Fixed an issue where, when Case Access Group Security was enabled, the system prevented completing workflow tasks with prompts. | SAF-40707 |
| Performance | Fixed an issue where, in some instances, system performance was slow during Case promotion and duplicate detection. | SAF-34694 |
| Performance | Fixed an issue where, when promoting an AER to a Case, system performance was slow when running duplicate detection. | SAF-36803 |
| Performance | Fixed an issue with Case validations where all duplicate Case identifiers were validated, which caused system performance issues. | SAF-37303 |
| Security | Fixed an issue where Read access permission for localized objects was required to view Inbox Items without localization. | SAF-36824 |
| UI/UX | Fixed an issue where, when user actions were prevented while the system generated Case Narratives, error messages did not describe the cause of the issue. | SAF-33377 |
| UI/UX | Fixed an issue where, when errors occurred during import of multi-E2B XML or Zip files from an API Transmission, system error messages did not describe the cause of the errors. | SAF-34296 |
| UI/UX | Fixed an issue with promoting Cases from the Case Compare page where, when an error occurred due to missing Read permission for the Language field, the system error message did not describe the cause of the issue. | SAF-37207 |
| UI/UX | Fixed an issue where, when errors occurred when adding Study Registrations, system error messages did not describe the cause of the issue. | SAF-37267 |
| UI/UX | Fixed an issue where, when a User Profile was set to any value other than English, the Dosage Frequency Unit field did not display selected values. | SAF-38025 |
| UI/UX | Fixed an issue where, when the Potential Matches screen returned more than 20 results, reviewing the left pane list of all potentially matching Cases was difficult. The pane now includes a scrollbar for better usability. | SAF-38284 |
SafetyDocs
Vault SafetyDocs 23R1 includes the following fixed issues.
PSMF Management
| Category | Description | Issue Number |
|---|---|---|
| Binders | Fixed an issue where, when creating binders with custom document types, after selecting Save the system displayed an error message although the binder was saved. This issue did not prevent merging binder documents into a PDF. | SAF-36450 |
| Logbooks | Fixed an issue where, when a PSMF Document was approved by a non-Vault Owner user, the lifecycle state of the PSMF Logbook Entry was not updated to "Final". | SAF-38473 |
| PDFs | Fixed an issue with PSMF PDF generation where the lifecycle state was not updated to Generated. | SAF-39665 |
