Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
You may encounter the following known issues or limitations in certain environments or configurations. Where possible, workaround instructions are provided to solve the issue.
Known Issues
We actively investigate all known issues and will be providing fixes and updated information in future releases.
Case Processing
FDA 3500A Contains Incorrect Follow-Up Number
SAF-2219
When you generate an FDA 3500A report from a Follow-Up Case, the system populates the Follow-up# field as 2 instead of 1.
Case Due Date and Submission Record Generation Fail When Case Product Registration Country is Blank
SAF-1388
If a Case references a Product record that does not specify the product registration country, the following scenarios fail with a null pointer exception error:
- When the system calculates the Case due date.
- When the system creates the Case Submission record.
Ensure that you set the product registration country for Case Products.
Age Group Disappears after Removing the Date of Birth on an AER
SAF-1345
If you edit an Adverse Event Report to remove the value in the Date of Birth field and save the page, the value in the Age Group field is cleared.
Object Number Skipped After Validation Error
SAF-1338
If a validation error occurs when you try to save an object, such as an Adverse Event Report or Aggregate Report, the system skips ahead to the next number in the series when assigning the name.
For example, if you do not specify the receipt date on the first Adverse Event Report in Vault Safety and try to save, a validation error appears. When you correct the receipt date and save the page, instead of assigning the name AER-000001, the system assigns the name AER-000002.
Cannot Create AER from Document While Loading File Rendition
SAF-1175
After uploading a source Adverse Event Report file to the Library, you cannot use the file to create an Adverse Event Report while the system is loading the file rendition.
If you select Create AER from Document from the 
menu while the system is loading the rendition, a message similar to the following appears:
Failed to update Document property of Document[6_0_1], with case ID[V2B000000000108].
Workaround
Wait until the system loads the rendition before you select Create AER from Document.
Unclear Error Message when Follow-Up Case Creation Fails
When a Case links to a Study that does not match the Study that the Case Product is associated with, the Case becomes out-of-sync and the system does not allow follow-ups.
When you try to create a Follow-Up Case on an out-of-sync Case associated with a Study, the system displays the following unclear error message:
An error occured while performing the action: [Input Position [0] Error [{type=’INVALID_DATA’, subtype=’null’, message=’Invalid value [SAF- 476_DoubleBlindNull] specified for parameter [study__v}’}]]
If you see this error message, ensure that the Study under the Case matches the Study associated with the Case Product.
Coding
Non-English MedDRA Dictionary Upload Fails
SAF-166
Vault Safety currently supports only English language versions of the MedDRA dictionary. When you try to upload a non-English dictionary, the upload operation fails.
Vault Safety will provide multi-language support for the MedDRA dictionary in a future release.
Safety Data Exchange
MedDRA Preferred Term from Not Imported from E2B(R2) File
SAF-1226
During an E2B(R2) import the system imports only MedDRA Lower-Level Terms (LLT).
If you specify the Preferred Term (PT) only, the system does not import the MedDRA value. However, if you specify both the LLT and PT for a data element, the system maps only the LLT.
Multiple E2B R2 Case Diagnoses are Not Imported
SAF-760
When you import an Adverse Event Report E2B file with multiple case diagnoses, the system may not import any diagnosis information.
This issue occurs when multiple diagnosis MedDRA codes are separated by any character that is not a comma, such as a semi-colon (;) or other special character.
Workaround
If you experience this issue, perform one of the following workarounds:
- Edit the E2B file to separate each MedDRA code using only a comma, and then re-import the Adverse Event Report.
- Manually create each Case Diagnosis record on the Case in Vault Safety.
Able to Enter Reasons Omitted on Source Literature when Field is Populated
SAF-466
On a Case source literature document, you should not be able to select a value in the Reference (reason omitted) field when you enter a value in the Reference field. However, the system currently allows you to enter values in both fields.
E2B Import Fails upon Data Mismatch
SAF-162
During E2B import, if the file contains a value that results in a data-type mismatch with the corresponding Vault Safety picklist or codelist field, the import operation fails. This issue does not affect text fields.
For example, if the E.i.6a: Duration of Reaction (unit) section contains a string value that does not map to the options in the Vault Safety Duration (unit) field, the import fails.
When this issue occurs, an error similar to the following appears:
We could not complete “Extract E2B” for the following reasons: NumberFormatException [SDK_ERROR:Mapping e_i_6a_durationNumber]]
Assessments with Reference Issues are Not Imported
Vault Safety does not import case assessments and assessment results from an E2B file when there have overlapping or incorrect references.
Limitations
Consider the following current product limitations when you use Vault Safety.
Case Processing
Cannot Complete Unblinding Task on Case with Drug or Biologic Products
SAF-1856
If a blinded Study Case references concomitant Drug or Biologic type Products, you cannot keep the blind when you complete the Unblinding task. This issue does not affect External-type Products.
If you select Keep the Blind as the verdict in the Unblinding task window, an error similar to the following message appears:
An error occurred while performing the action: Field [blinded__v] is not valid for Object Type [biologic__v]
Workaround
If this issue occurs, contact your Veeva Services representative.
Unexpected Results after Enabling Blind Protection on Product Record
SAF-987
If you turn on blind protection on a Study Product record, you may see unexpected results. The Case or Study blind protection settings override the Product settings.
For example, if you turn on blind protection on a Study Product under a Case with blind protection turned off, the Product is not blinded.
We recommend that you only configure blind protection at the Case or Study level.
Copied Case Does Not Contain Child Records
When you create a copy of a Case, the Case descendant records are not copied to the new Case. The system copies only the Details, Narrative, Patient, and System sections to the new Case. You must manually add all Case descendant records.
Cannot Calculate Age When an Adverse Event Occurred On or Before Birth Date
In the scenario where an adverse event occurred before or on the patient’s birth date, be aware of the following limitations.
Adverse Event Report Age Calculation
In a Vault Safety Adverse Event Report, if the date entered in either the Event Onset or Receipt Date field is on or before the date entered in the Date of Birth field, the system cannot calculate the patient’s age.
When this scenario occurs, the system displays an error. To save the Adverse Event Report, you must manually enter the patient’s age at the onset of the adverse event in the Age field.
Case Age Calculation
In a Vault Safety Case, if you add an adverse event with an Onset date on or before the date entered in the Patient > Date of Birth field, the system updates the value in the Patient > Age field to 0. Manually enter the patient’s age at the onset of the adverse event in the Age field.
Generated CIOMS I Contains Age Field in Scientific Notation
When you generate a CIOMS I for a Case with a normalized Age at Onset value that is too long to fit in the CIOMS I Age field, the system populates age value in scientific notation.
This issue occurs because the CIOMS I Age field is in years. When Vault Safety calculates an age with a partial year, the age becomes a decimal value that may not fit in the CIOMS I form. When the value does not fit in the form, the system generates the scientific notation equivalent.
For example, if a patient’s Age at Onset is 12 hours, Vault Safety calculates the normalized age as 0.0014 years, which is populated as 1.4e3 in the CIOMS I Age field.
3500A Generation Does Not Support Devices Section
Vault Safety does not yet support the FDA 3500A Devices section. When you generate a FDA 3500A report, the system leaves the Devices section blank.
Report Generation Missing Suspect or Interacting Products
Currently, Vault Safety is limited in the number of suspect or interacting products that it can populate when generating a case report.
In 19R1, Vault Safety supports exporting the following number of suspect or interacting products during report generation:
- Only one suspect or interacting product for the CIOMS I report.
- Only two suspect or interacting products for the FDA 3500A report.
If the number of suspect or interacting products exceeds the above limits, the additional product information is not populated on the report.
Coding
WHODrug Browser Does Not Return Results for Partial Search
SAF-1045
The WHODrug Search browser may not return results for incomplete product names.
The browser searches for product names that match the exact spelling of the search input. You can search incomplete product names only when you enter the letters the name starts with.
For example, if you are looking for the product Cholecap and search for lecap with the Drug Name column selected, the search returns no results. However, if you search chole, the search returns results for Cholecap.
Make sure to use the correct spelling for search terms. If you must search a partial name, always search using the start of the product name.
Cannot View MedDRA Records While Loading Dictionary
SAF-148
When you start uploading a MedDRA dictionary from Business Admin > Dictionaries > MedDRA Dictionary, you cannot view MedDRA records on the Business Admin > MedDRA page until the system finishes uploading the dictionary.
While the upload is in progress, the MedDRA page displays a “Page Not Found” error. The system sends an email notification when it completes the upload action.
Configuration
Disabling Standard Fields on Custom Object Types May Cause Functionality Issues
When you create custom object types on Veeva standard objects, you should not disable standard fields. If you disable standard fields on the custom object type, Vault Safety may not work as intended. You can identify standard objects and fields by the __v in the name.
Disabling Page Layout Rules on Study Allows Non-Study Primary Product
When you disable page layout rules on a Case associated with a Study, you are able to set a non-study Product as Primary, which causes the system to clear all study-related information under the Case.
If this issue occurs, set the non-study product Primary field to No and set the appropriate Study Product Primary field to Yes. Once you set a Study Product as Primary, the system restores all study information under the Case.
If the Case has two or more Study Products and you try to change the Primary Product to a non-study Product, the system prevents you from saving the changes with an error message similar to the following:
We could not save “Case Product” for the following reasons: One or more Case Products dependent on this Study.
If page layout rules are enabled, the layout rules prevent this scenario from occurring.
Custom Notification Token Values are Not Populated
If you configure a custom notification with a token for Vault Safety actions, the notification does not populate the token value.
You cannot use Vault Safety-specific tokens in custom notifications. For custom messages, the system is limited to display only standard Vault tokens, such as Vault ID or domain.
Vault Online Help website provides information on using standard Vault tokens.
Safety Data Exchange
Imported Case Missing Library Product and Study Information
SAF-1262
When you import an E2B file that maps to a Study configured in Vault Safety, the imported Case is missing study registration and product information that exists in the Study library but not in the E2B file.
This issue impacts the following Case records:
- Study Registration
- Product Substance
Workaround
If you experience this issue, deselect and reselect the Study or Product.
Reaction Recurrence Section is Not Imported from E2B(R2) File
SAF-1208
When you import an E2B(R2) file, the system imports the <!--B.4.k.17 reaction recurrence--> section only when the <drugrecurreadministration> tag contains either 1 or Yes-yes. If the tag contains any other value, the system does not import the section.
The system notification about the E2B import does not display a warning about losing the recurrence data.
E2B(R2) Export Contains UCUM Text Instead of Code
SAF-1184
When you export a Case with lab test results as an E2B(R2) file, the system exports the test result unit as text instead of the Unified Code for Units of Measure (UCUM) numeric code.
For example, for a test result with a unit of kg, the system populates the E2B file with <testunit>kg</testunit> instead of using the UCUM code for kg, 001.
Cause of Death with Invalid MedDRA Code is Not Imported from E2B(R2) File
SAF-1155
If you import an E2B(R2) file with an invalid MedDRA code in either of the following sections, the system does not import that section to the Vault Safety Case:
B.1.9.2.b Reported cause(s) of deathB.1.9.4b Autopsy-determined cause(s) of death
Test Result Unit and Qualifier from E2B(R2) File are Not Correctly Mapped
SAF-1151
When you import an E2B(R2) file with lab test results, the system may not correctly map the result unit and qualifier.
Instead of populating the qualifier and test result code, the system may map the result, result unit, and qualifier information to a combined free text description in the Result (Text) field.
The following known limitations cause this behaviour:
- The system cannot interpret qualifier symbols (<, <=, >, >=) within the
testresulttag - The system cannot interpret numeric code values in the
testresulttag
If you import an E2B(R2) file with lab test results, verify that the Case contains the correct records under Lab Test Results and, if required, manually map the information to the Result and Result (qualifier) fields.
MedDRA Code Not Imported from E2B File
SAF-1142
When you import an Adverse Event Report E2B file with both a valid MedDRA code and MedDRA free text, the system does not map the MedDRA code to the Name (MedDRA) field. Instead, the system maps both the MedDRA code and the free text to the Name(Reported) field.
E2B Import Failure Logs Only the First Error
SAF-1062
When an E2B import action fails with multiple issues, the log file contains only the first error that the operation encountered. After encountering an issue, the system stops processing the file.
Unclear Error Message when Importing an E2B File Missing a Required Field
SAF-1057
If you edit a Case field to turn on User must always enter a value (required), when you import an E2B file that does not contain a value for that field, the import operation fails without a clear failure notification.
Do not change the User must always enter a value (required) option on standard Object Type Fields under the Case object if you are importing E2B files.
Cannot Create Follow-Up Case from E2B Import
You cannot import an E2B file to create a Follow-Up Case directly. E2B import is supported to create an initial Case only.
Workaround
- Import an E2B file to create an Adverse Event Report.
- Create the Follow-Up Case.
- Manually copy over the Case updates in the imported Adverse Event Report to the Follow-Up Case.
