Safety Application Settings & Configuration Options

Various settings, actions, and configuration options are available for Safety Vaults.

Settings

To enable and configure application settings:

1. Navigate to Admin > Settings.
2. In the Application Settings section, select a category of settings.
3. On the selected settings page, select Edit.
4. Enter your changes and then select Save.

Intake Settings

Manage the Intake Settings in your Vault:

Import

• Enable Sender-Based Inbound Validation: When enabled, Vault generates inbound validation results in the Inbound Validation Result section of Inbox Items.

Product Coding

For more information on these Product Coding settings, see Enable Company Product Match Verification.

• Enable Advanced Product Coding Verification: When enabled, Vault displays and populates the Product Match Confidence and the Product Match Criteria fields on Inbox Items.
• Enable Advanced Product Coding Verification Auto coding Override: When enabled, Vault does not auto-code any rank 1 Company Product that does not meet the auto-code minimum Product Match Confidence level. To use this setting, you must select the Enable Advanced Product Coding Verification checkbox.
• Must Match: Specify fields that must match when Vault evaluates the Product Match Confidence level on Inbox Items.
• Should Match: Specify fields that should match when Vault evaluates the Product Match Confidence level on Inbox Items.
• Auto code min Product Confidence level: Specify the minimum product match threshold Vault uses when auto-coding Company Products. To use this setting, you must select the Enable Advanced Product Coding Verification Auto coding Override checkbox.

Duplicate Search Options

For more information on these Duplicate Search Options settings, see Configure Case Promotion Settings.

• Perform Deep Duplicate Search on Spontaneous Cases: When enabled, during duplicate detection, Vault searches for potential matches in Cases with the Report Type set to Spontaneous. Optionally, edit the maximum number of potential match results that Vault returns.
• Perform Deep Duplicate Search on Study Cases: When enabled, during duplicate detection, Vault searches for potential matches in Cases with the Report Type set to Study. Optionally, edit the maximum number of potential match results that Vault returns.
• Perform Deep Duplicate Search on Inbox Items: When enabled, during duplicate detection, Vault searches for potential matches in open Inbox Items.
• Index Migrated Cases: When enabled, Vault displays migrated Cases on the Potential Matches page.

Initial Case Options

• Allow Copy Patient Information: Adds the New Case - Copy Patient Information option to the Inbox Item to Case Compare page during Inbox Item promotion.

Follow-Up Options

For more information on these Follow-Up Options settings, see Configure Case Promotion Settings.

• Allow Follow-Up from Inbox Item: Adds the Create Follow-Up option to the Inbox Item to Case Compare page during Inbox Item promotion.
• Allow follow-up with any matching UID: Enables users to promote Inbox Items to Follow-up Cases when the WWUID does not match the previous Case version but does match another UID on the Case.
• Prohibited States: Prevents combining Cases in specific lifecycle states with Inbox Items to create Follow-up Cases from the Inbox Item to Case Compare page.

Allow Merge Into Active Case

For more information on these Allow Merge Into Active Case settings, see Configure Case Promotion Settings.

• Merge to Active Case Version: Adds the Merge to Current option on the Inbox Item to Case Compare page during Inbox Item promotion.
• Prohibited States: Prevents merging Inbox Items into Cases in specific lifecycle states from the Inbox Item to Case Compare page.
• Require user performing merge to have edit access to target case: Restricts the Merge to Current action to users with Edit access on the applicable target In-flight Case.

Allow Mark Follow-up

For more information on these Allow Mark Follow-up settings, see Configure Case Promotion Settings.

• Allow Mark Follow-up: Adds the Mark as Follow Up option to the Inbox Item to Case Compare page during Inbox Item promotion.
• Prohibited States: Prevents linking Cases in specific lifecycle states to Inbox Items.

ICSR Reporting Settings

Manage the ICSR Reporting Settings in your Vault:

Submissions

• Cancel Auto-Submit for Translations: Prevents auto-submissions for Cases with unapproved Localized Cases.
• Suppress File Generation for Auto-Submit Transmissions: Prevents Vault from generating the Auto-Submission document before the initial document. Contact Veeva Managed Services to determine whether you should enable this setting.
• Substitute Product/Study for Cross Reporting: Specify how Vault evaluates the Product, Product Family, and Study reporting rule parameters during cross reporting.
• Logically Delete Non-Submittable Transmissions on Subsequent Evaluations: Supports the logical deletion of non-submittable Transmissions after the Vault Safety reporting rule engine re-evaluates reporting obligations on updated Cases.
• One Last Time Reporting for all Destinations: Configures One Last Time (OLT) reporting logic for all reporting destinations with Transmissions in the selected states, regardless of the rule set configuration.
• One Last Time Reporting for Japan: Configures One Last Time (OLT) reporting logic for reporting to the PMDA for Transmissions in the selected states, regardless of the rule set configuration.
  • Due in Days for Local OLT Submissions: Specify a number value Vault uses to populate the Due in Days field for all local OLT submissions. This setting appears only after you select a value in the One Last Time Reporting for Japan field.
• Transmission Reason Determination: Defines the states of previous Transmissions that Vault considers when determining if a rule engine-created Transmission is Initial or Follow-Up.
• Cross Reporting without Datasheet Expectedness Substitution: Determines how the Vault Safety reporting rule engine evaluates the Expected rule parameter for cross reporting scenarios where additional Products are found through a Substance lookup.
• Strict Transmission Version Enforcement: When enabled, Vault enforces the order in which you are able to send Transmissions via gateway and email to all destinations.

Submission and Distribution Settings

Manage the Submission and Distribution Settings in your Vault:

Transmission Document Export Settings

• Mask Reporter For PM Non-Literature Case: When enabled, Vault masks reporter information in all outbound Submissions and Distributions for postmarket non-literature Cases.
• Export IMDRF Codes on MedWatch 3500A: When enabled, Vault exports International Medical Device Regulators Forum (IMDRF) device codes instead of FDA device codes to FDA MedWatch 3500A forms.
• Use Adverse Event PT on CIOMS and MedWatch 3500A: When enabled, Vault displays adverse events using MedDRA Preferred Term (PTs) on CIOMS I and FDA MedWatch 3500A forms.
• Use Product(Reported) Name on CIOMS and MedWatch 3500A: Defines whether Vault exports reported or coded Products by default on CIOMS I and FDA MedWatch 3500A forms.
• Mask Dosage on Blinded Forms: When enabled, Vault masks dosages in blinded report previews and masked Distributions.
• Display Unmasked Open-label Products on Blinded CIOMS and MedWatch 3500A: When enabled, Vault always unmasks open-label Products within blinded Studies on blinded CIOMS I and FDA MedWatch 3500A forms
• PMDA E2B: Do not export UCUM code not supported by PMDA: Prevents exporting unsupported Unified Code for Units of Measure (UCUM) codes to PMDA E2B(R3) reports.
  • Export {DF} for unsupported UCUM code if number is specified: Select this setting if you want Vault to export {DF} in place of unsupported UCUM codes on PMDA E2B(R3) reports. This setting appears only after you select the PMDA E2B: Do not export UCUM code not supported by PMDA checkbox.

Safety Security Settings

Manage the Safety Security Settings in your Vault:

Case Access Groups

Before enabling Case Access Group Security and configuring any of the related settings in your Vault, you must contact Veeva Managed Services.

• Enable Case Access Groups: Enables the Case Access Group Security feature.
• Secure Users by Case Access Group: Limits the visibility of Vault users to each other by Case Access Group.

Blind Protection

• Blind-Protected Objects: Specify objects that will be blind-protected.
• Unprotected Drug Roles: Specify Case Product Drug Roles, such as Concomitant, that do not require information to be blind-protected.
• Unprotected Study Product Roles: Specify Study Product Roles, such as Standard of Care, that do not require information to be blind-protected.

Case Locking

• Enable Strict Case Locking: Restricts editing Cases and Case-descendant objects to only the user identified in the Locked By field on an applicable Case.
  • Excepted Fields: Identifies Case fields that remain editable to users, regardless of the Locked By field setting.

Other Options

• Mask PHI and PII on the Potential Matches Page: When enabled, Vault masks protected health information (PHI) and personally identifiable information (PII) on the Potential Matches page during duplicate detection.

Safety General Settings

Manage the Safety General Settings in your Vault:

Date/Time Options

• Allow partial date entry for Case Product Expiration, Implanted Date, Explanted Date, Returned Date: Allows Case Processors to enter partial dates in Case Product device fields.

Auto-calculation Settings

• Allow manual override of auto-calculated fields: Allows users to override Vault auto-calculations and manually enter data in certain fields.

Domestic Cases

• Enable auto-set Inbox Item Localization by Reporter Country: When enabled, Vault automatically sets Inbox Item localization based on reporter locale.
• Enable State/Province Selector: When enabled, Vault references the Country State/Province library for domestic state code mapping.
• Enable Localization-based Mapping on Import: Enables importing local Cases to Inbox Items from an E2B or Intake API source.

Metrics

Case Volume Metrics

• Frequency: Defines whether Vault runs the Case Volume Metrics job hourly or daily.
• Case Initial: Defines the Case lifecycle states Vault considers as initial when running the Case Volume Metrics job.
• Case Active: Defines the Case lifecycle states Vault considers as active when running the Case Volume Metrics job.
• Case Completed: Defines the Case lifecycle states Vault considers as completed when running the Case Volume Metrics job.

Other Options

• Allow localized record deletion from Case: Allows users to delete localized child and grandchild records when deleting the global Case children.
• Extend Suspect Definition to Include Drug Not Administered: Defines whether Vault evaluates Case Products with a Drug Role of Drug Not Administered as suspect.
• Enable Isolation of Blinded Product Information: Allows you to configure your Vault to isolate blinded product information for Clinical Trial Study Cases. Before enabling this feature, you must contact Veeva Managed Services.
• Extend Seriousness to include Required Intervention to Prevent Permanent Impairment/Damage (Medical Device/Combination Products Only): To support migrating Device and Combination Product Cases, this setting updates the Case- and Adverse Event-level Seriousness picklists to include Required Intervention to Prevent Permanent Impairment/Damage (Devices).
• Turn off Blind Protection on Narrative: Turns off blind protection on Narratives generated for Study Cases.
• Enable Follow-up Compare with Summary: This setting will control the functionality of the Follow-up Compare with Summary feature, which is coming in a future release.

Auto-generate Assessments

• Generate Assessments for both Serious and Non-Serious Adverse Events: Enables Case Processors to generate Assessments, Assessment Results, and Expectedness records for all serious and non-serious Adverse Events on a Case.
• Calculate Clinical Trial Case Expectedness using “Based On” field: When enabled, Vault calculates expectedness on Clinical Trial Study Cases using Adverse Event Onset date or Case New Info Date, depending on the Based On setting for each Agency.

Post-Closure Quality Control

• Post-Closure QC Interval: Defines the interval at which Vault identifies closed Cases for post-closure QC checklist generation.

Aggregate Report Settings

Manage the Aggregate Report Settings in your Vault:

Aggregate Report Authoring

• Generate Tabulations Using Sections: Allows users to generate and manage tabulations using Aggregate Report Sections.

CIOMS II

• Allow Narrative Preview to be included in the report: Defines whether Narrative Previews are included in CIOMS II reports.

DSUR / PBRER

• Only Include Investigational Products for SAR: When enabled, Vault considers only causal assessments related to investigational Products for inclusion in DSURs and PBRERs.
• Use templates with calculated totals for tabulations, once uploaded: When enabled, Vault displays summary and grand totals in DSUR and PBRER tabulations and generating log files in a separate Log file.
• Display Assessment Results and Case Totals on SAR Line Listings: When enabled, Vault displays Case Assessment Results and Case subtotals and grand totals on DSUR and PBRER Interval Line Listings of Serious Adverse Reactions.

PSUR

• Use template with calculated totals for tabulations, once uploaded: When enabled, Vault adds summary and grand totals to PSUR tabulations and generates the Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions Logs in a separate Log file.

Safety Rules Troubleshooting

Use the Safety Rules Troubleshooting tool to diagnose and fix issues when Safety reporting rules, including custom rules, are failing.

SafetyDocs Settings

Manage the SafetyDocs Settings in your Vault:

PSMF

• PSMF Logbook Ordering: Defines whether PSMF Logbook entries are ordered by date of entry or by section and annex.