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 20R3. For details about fixes issues in the Vault Platform in 20R3, see the Vault Release Notes.
Note An asterisk (*) next to the issue number denotes an internally found defect filed during the development of Limited Release features.
Safety
The following Vault Safety issues are fixed in 20R3.
Intake
| Category | Description | Issue Number |
|---|---|---|
| Case Promotion | Fixed an issue where AERs created from an E2B import cannot be promoted to a case if the Auto-Follow-Up action has been run. | SAF-10171* |
| Case Promotion | Fixed an issue that prevented an AER promotion to a case that was accompanied by a "Record Null" error. | SAF-10188 |
| E2B Import | Fixed an issue where Reason Omitted values for Batch/Lot numbers were not being mapped to Vault during E2B (R3) Import. | SAF-10687, SAF-11358 |
| E2B Import | Fixed an issue where E2B imports through the API or AS2 Gateway failed when the Auto-Submit field was set to Yes on the associated Transmission Profile. | SAF-11917* |
| E2B Import | Fixed an issue where the Drug Name data element was not imported when the G.k.2.2.EU.1 data element was present. | SAF-6107 |
| E2B Import | Fixed an issue where importing an E2B R2 file missing dose frequency unit delivered a warning notification with an E2B R3 code. | SAF-6628 |
| E2B Import | Fixed an issue where an E2B import would fail if the user input a non-numeric entry into a value field. | SAF-8043 |
| E2B Import | Fixed an issue where the Source Document field was left blank after opening an E2B imported Case. | SAF-8971* |
Case Processing
| Category | Description | Issue Number |
|---|---|---|
| Auto-Calculation | Fixed an issue where the Age at Vaccination field was not being auto-calculated on Study Cases with a Vaccine-type Case Study Product. | SAF-8965* |
| Case Promotion | Fixed an issue where AERs could not be promoted to Cases when the AER Report Type was Study, the Study was double-blinded, and the Study Product was external (not in the product library). | SAF-9893 |
| Data Entry | Fixed an issue where EMA ELISA, ELU, and hp_X Units of Measurement were not provisioned. These Units of Measurement have now been provisioned. Note that the new units are only applicable to EMA, but all users will be able to see them in their vaults. | SAF-10892, SAF-11735 |
| Data Entry | Fixed an issue where Reason Omitted (nullFlavor) values for patient name fields were not being snapshotted from the AER to Case. | SAF-10908 |
| Data Entry | Fixed an issue where the Site Reporter email address was not being snapshotted from the AER to Case when the vaccine feature was enabled. | SAF-10944 |
| Data Entry | Fixed an issue where the Last Name field was missing the Masked (MSK) option in the reason omitted (null flavor) picklist for Reporter-type Case Contacts. | SAF-11377 |
| Data Entry | Fixed an issue where if the Frequency number was 6, it was being incorrectly rounded off to 5 on Sections 15 and 22 of CIOMS I forms. | SAF-11645 |
| Data Entry | Fixed an issue where the Title, First Name, Middle Name fields were missing MSK, ASKU, NASK as Reason Omitted (nullflavors) picklist options for Reporter-type Case Contacts. | SAF-11696 |
| Data Entry | Fixed an issue preventing users from saving a custom dosage in Product > Dosage > Dose field. | SAF-11709* |
| Data Entry | Fixed an issue where an error appeared while saving a Study Product if the Frequency field numeric value exceeded 2 decimal places. | SAF-11794* |
| Data Entry | Fixed an issue where the Frequency control was missing on Study Product Dosage records. | SAF-7446 |
| Data Entry | Fixed an issue where, on the Case Product, the Indication (Reported) field was saved instead of returning to the previous value after attempting to cancel editing the record. | SAF-8606 |
| Data Entry | Fixed an issue where some Patient name fields were not enabled on Imported Cases. | SAF-9197 |
| Data Entry | Fixed an issue where the Country and Street Line 2 Reason Omitted fields were not enabled by default on the Facility object type. | SAF-9420 |
| Data Entry | Fixed an issue where the Test Name (Reported) field on Case Test Result was labeled incorrectly. | SAF-9484 |
| Follow-Ups | Fixed an issue where Follow-Up Cases could not be created if the Case contained a Facility-type Case Contact that was selected in the Administration Facility field on the Case Product Dosage. | SAF-10548 |
| Data Entry | Fixed an issue where a NullPointer error message appeared when the system attempted to snapshot the preconfigured Substance information to a Case Product. | SAF-9542, SAF-9617 |
| Follow-Ups | Fixed an issue where after creating a Follow-Up Case from an initial Case in the Closed state, Case descendant objects did not transition to the Active state. | SAF-9589 |
| Follow-Ups | Fixed an issue where Case child records could not be edited on Follow-Ups created from a Closed case. | SAF-9570 |
| Follow-Ups | Fixed an issue where Follow-Up Cases could not be created from the Potential Matches page if the original Case had both Reporter and Sender Case Contacts listed. | SAF-9419 |
Coding
| Category | Description | Issue Number |
|---|---|---|
| MedDRA | Fixed an issue where search terms starting with numeric characters did not work when applying filters in the MedDRA browser. | SAF-11624 |
| MedDRA | Fixed an issue with central MedDRA where non-primary SOC terms were not updated when the central dictionary was updated to a new version. | SAF-10293* |
| MedDRA | Fixed an issue with the Central MedDRA dictionary where appropriate Watchlist Tags were not added to a Case or Adverse Event if the reported event was a Lower Level Term. | SAF-10436 |
| MedDRA | Fixed an issue where search filters on the Central MedDRA browser were case sensitive. | SAF-10878* |
| MedDRA | Fixed an issue where the non-primary tag appeared incorrectly after selecting a non-primary term from the browser and then clearing that term. | SAF-9048 |
| MedDRA | Fixed an issue where a follow-up case could not be created upon upgrading MedDRA. | SAF-9503 |
Aggregate Reporting
| Category | Description | Issue Number |
|---|---|---|
| PADER | Fixed an issue where both Initial and Follow-Up versions of the same Case were counted on PADER report tabulations when each had the Transmission Reason set to Initial. | SAF-8357 |
Report Generation
| Category | Description | Issue Number |
|---|---|---|
| CIOMS I/FDA 3500A | Fixed an issue where a form generation error prevented CIOMS I and FDA 3500A forms from generating for certain Cases imported from E2B. | SAF-12856 |
| E2B Export | Fixed an issue where a Test Result "Normal Low Value" (F.r.4) and "Normal High Value" (F.r.5) were being exported as text in E2B R3 files. To comply with ICH guidelines, these elements will now be transmitted as numeric values. | SAF-12919 |
| E2B Export | Fixed an issue where, when a Case Test Result contained two or more of the below three values, all values were included in exported EMA E2B R3 files:
|
SAF-12867 |
| E2B Export | Fixed an issue where empty patient and parent sections were included in system-generated EMA E2B R3 files. To comply with EMA specifications, if patient or parent information is not provided, the empty sections are now omitted from generated EMA E2B R3 files. | SAF-12865 |
| E2B Export | Fixed an issue where E2B files failed to generate when placeholder literature documents had the Retransmit field set to Yes. | SAF-12664 |
| E2B Export | Fixed an issue where incorrect Code System Version (CSV) values were being populated in system-generated E2B R3 files, resulting in ACK errors. To comply with ICH guidelines, E2B R3 files are now formatted with the latest CSV values. | SAF-12374 |
| E2B Import/Export | Fixed an issue where Case Medical History Text was not being imported or exported in the correct format for EMA E2B files. | SAF-12262 |
| E2B Export | Fixed an issue where Parent Gender was not being exported in Masked E2B (R3) files. | SAF-10272 |
| E2B Export | Fixed an issue where the file name was being populated in an incorrect format when auto-generating E2B (R2), (R3), and FDA E2B (R2) files through a Transmission. | SAF-10472 |
| E2B Export | Fixed an issue where E2B exports from a Transmission record did not consider the Expedited field on the Transmission record when populating the Does This Case Fulfill the Local Criteria for an Expedited Report? data element. | SAF-10480 |
| E2B Export | Fixed an issue where a warning about the Dose Form value being truncated was appearing when generating E2B (R3), EMA E2B (R3), and FDA VAERS E2B (R3) files. | SAF-10578 |
| E2B Export | Fixed an issue where, if Dosage Frequency was not entered, a warning about a non-standard frequency being entered was appearing when generating E2B (R2) files. | SAF-10585 |
| E2B Export | Fixed an issue where the Best Doctor Email (FDA.E.i.3.4e) was not being mapped in FDA VAERS E2B exports. | SAF-11744* |
| E2B Export | Fixed an issue where an incorrect E2B warning notification was generated when the Dose Form field exceeded 60 characters. | SAF-9001 |
| E2B Export | Fixed an issue where E2B R2 exports contained a leading '0' for dosage intervals with a decimal number. | SAF-9116 |
| E2B Export | Fixed an issue with E2B file generation where data element B.4.k.7 was set to blank when only the Dose Form Term ID field was populated. | SAF-9267 |
| FDA 3500A | Fixed an issue where the FDA MedWatch 3500A form had an invalid expiration date at the top of the form. | SAF-10477 |
| FDA 3500A | Fixed an issue where device codes were not included with vaccine-type product constituents in the FDA MedWatch 3500A form. | SAF-9039* |
Transmissions
| Category | Description | Issue Number |
|---|---|---|
| Gateway Transmissions | Fixed an issue where transmissions would not proceed past the Sending ICSR State. | SAF-10046 |
| Gateway Transmissions | Fixed an issue where Inbound Transmissions received through AS2 Gateway failed to return an ACK to the sender. | SAF-10114 |
| Gateway Transmissions | Fixed an issue where the Submit to Gateway action appeared on all Case lifecycle states. | SAF-11718* |
| Email Distributions | Fixed an issue where email Transmissions with auto-submissions enabled go to the Ready for Submission state when the Case-level "Submit to Gateway" action is run. | SAF-11749* |
| Reporter Email Follow-Ups | Fixed an issue where a Correspondence fails to be created when an invalid email format is used for the Primary Reporter. | SAF-10056* |
| Reporter Email Follow-Ups | Fixed an issue where reporter first and last names defaulted to Not_Provided on emails when the corresponding fields are blank. | SAF-10553* |
| Reporter Email Follow-Ups | Fixed an issue where case correspondence records failed to be created when 5 or more matching templates are used on a case. | SAF-9737* |
| Transmission Generation | Fixed an issue where transmission documents failed to generate from a Transmission record due to the "Generate Transmission Document(s)" from Pending state Entry Action. | SAF-11907 |
System
| Category | Description | Issue Number |
|---|---|---|
| Audit Log | Fixed an issue where the Audit Trail did not record the number of results returned by duplicate detection. | SAF-11957 |
| Lifecycles & Workflows | Fixed an issue where the Initialize Due Date workflow step was setting the due date exclusively by receipt date. | SAF-8968 |
| Lifecycles & Workflows | Fixed an issue where the entry action rules for the Case Revision state executed twice. | SAF-9215 |
| Lifecycles & Workflows | Fixed an issue in certain custom workflow configurations where an error message incorrectly appeared saying new_info_date__v did not have a value when moving a Case to the Data Entry state. | SAF-9915 |
| Notifications | Fixed an issue where after a SUSAR Case and re-evaluating reporting obligations, the notification about the Transmission being generated was not sent to the initiating user. | SAF-8810 |
| Notifications | Fixed an issue where an incorrect error message would display when running the Evaluating Reporting Obligations action with a Transmission profile that has an empty Format field. | SAF-9882 |
| Performance | Fixed an issue causing the page load time for Cases to be extended. | SAF-9461 |
| Security | Fixed an issue where some configurations were allowing child records to be added to Superseded Cases. | SAF-7599 |
| Security | Fixed an issue where a console error was appearing if a user without 'Read' permission for fields tried to view Case Product records. | SAF-8978 |
| User Interface | Fixed an issue where combined field controls were misaligned when viewed using an Internet Explorer browser. | SAF-9282 |
| User Interface | Fixed an issue where the MedDRA field control was displaying incorrectly for records with "Create record in pop-up dialog" enabled. | SAF-4722 |
| Vault Management | Fixed an issue where vault configuration reports failed due to invalid date format. | SAF-9626 |
SafetyDocs
The following Vault SafetyDocs issue is fixed in 20R3.
System
| Category | Description | Issue Number |
|---|---|---|
| Security | Fixed an issue in SafetyDocs where non Vault Owner users were unable to create new organization records of type Agency. | SAF-6328 |
Safety.AI
The following Vault Safety.AI issues are fixed in 20R3.
Intake
| Category | Description | Issue Number |
|---|---|---|
| Case Promotion | Fixed an issue where all Case Assessment records with the Primary Product were assigned Rank 1. | SAF-10504* |
| Data Entry | Fixed an issue where the Organization, Department, and associated Reason Omitted fields were not disabled when the qualification was set to patient on the Contact record. | SAF-10204 |
| Data Entry | Fixed an issue where the Reported Field text value was not retained when the user refreshed the page after saving the Product. | SAF-10858 |
| Duplicate Detection | Fixed an issue where the Receipt Date value for a Case was not displayed on the Potential Matches page. | SAF-10986* |
| Validation | Fixed an issue where the Reporter checkbox was not enabled upon case intake. | SAF-10461 |
| Validation | Fixed an issue where Vault would provide incorrect suggestion text in the awareness details section, and incorrect product and event type text for particular user profiles. | SAF-9148 |
| Validation | Fixed an issue where no indication was displayed to users that a frequency value and unit must be entered before an AER can be created | SAF-9205 |
| Validation | Fixed an issue where the Reporter Language field was still enabled when the Reporter checkbox was unchecked in the Create Reporter Record page. | SAF-9736* |
| Validation | Fixed an issue where a server issue would occur when the user accessed an Inbox Item with a Transmission ID selected. | SAF-9794* |
| Validation | Fixed an issue where the Primary Phone field can still be selected under Contact #2 when Contact #1 is using the Primary Phone field. | SAF-9905* |
| Verification | Fixed an issue where a server error occurred upon section verification if Read Permissions were not assigned for Inbox item object fields. | SAF-11028 |
| Verification | Fixed an issue where the Inbox Item Detail and Patient sections did not show Verified after selecting the Verify button. | SAF-11256 |
| Verification | Fixed an issue where when verifying an age with no unit, if you selected the "No Unit Found" suggestion on the unit dropdown, the field was populated incorrectly. | SAF-11880* |
| Verification | Fixed an issue where if Case Contact Qualification was set to Patient, the Reason Omitted field for Primary Phone was grayed out. | SAF-11887 |
| Verification | Fixed an issue where a server error appeared after verifying or deleting an Adverse Event, Product, or Reporter on an Inbox Item. | SAF-9064 |
| Verification | Fixed an issue where you could not save a Product record on an Inbox Item after selecting the Other option in the Frequency field. | SAF-9210 |
| Verification | Fixed an issue where a server error appeared when you attempted to save or verify a Product after undoing a Dosage marked for deletion when that dosage was empty. | SAF-9490 |
System
| Category | Description | Issue Number |
|---|---|---|
| Notifications | Fixed an issue where the "Unsaved data will be lost" message was displayed to users when there was no unsaved data. | SAF-10081 |
| Security | Fixed an issue where a Server Error appeared when first opening an Inbox Item after logging in with a baseline security profile user. | SAF-10721 |
| Security | Fixed an issue where a server error appeared when attempting to access an Inbox Item if the user's Security Profile did not grant permission to the Safety System Security setting. | SAF-9003 |
| Security | Fixed an issue where a server error appeared when accessing the Product section on an Inbox Item if the Read permission was not selected for every object in a user's Security Profile. | SAF-9043 |
| Security | Fixed an issue where the Product Section label displayed to a user with the baseline security profile was incorrect. | SAF-9301* |
| User Interface | Fixed an issue where the header for records marked for deletion was at 100% opacity when viewed on an Internet Explorer browser. | SAF-10193 |
| User Interface | Fixed an issue where sections repeated on the Inbox Item shifted down the page while verifying or expanding in a Safari browser. | SAF-8980 |
| User Interface | Fixed an issue where the Product Types were not displayed in alphabetical order. | SAF-9749* |
| User Interface | Fixed an issue where certain fields were misaligned when viewed in the Safari or Chrome web browsers. | SAF-9809*, SAF-9854* |
