# Safety Application Settings & Configuration Options

Various settings, actions, and configuration options are available for Safety Vaults. 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 {#intake}

Manage the _Intake Settings_ in your Vault:

### Import

* **Enable Sender-Based Inbound Validation**: When enabled, Vault <a href="/en/gr/680653/">generates inbound validation results</a> in the <a href="/en/gr/01285/#validations">_Conformance Validations_ section</a> of _Inbox Items_. 
* **Disable Automatic Intake of AER Documents**: When enabled, Vault does not automatically generate _Inbox Items_ for <a href="/en/gr/01139/#aer">_Adverse Event Report_ documents</a> uploaded to your _Library_. This setting is only available in Vaults using Veeva AI for Safety.

### Product Coding {#prod-coding}

* **Exclude Concomitant Products from Auto-Coding**: If enabled, when a user imports a structured source file to create an _Inbox Item_, Vault does not attempt to <a href="/en/gr/01162/">auto-code</a> concomitant products to _Products_ in the _Product_ library.
* **Enable Advanced Product Coding Verification**: When enabled, Vault populates the _Product Match Confidence_ and the _Product Match Criteria_ fields on primary _Company Products_ on _Inbox Items_.
* **Must Match**: Specify fields that must be populated and match when Vault evaluates the _Product Match Confidence_ level on _Inbox Items_.
* **Should Match**: Specify fields that must match if populated when Vault evaluates the _Product Match Confidence_ level on _Inbox Items_.
* **Enable Advanced Product Coding Verification Auto coding Override**: When enabled, Vault does not auto-code any primary _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.
* **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.
* **Extend Advanced Product Coding verification to all Suspect/Interacting**: When enabled, Vault applies the _Advanced Product Coding Verification_ setting to the first 500 imported _Company Products_ <a href="/en/gr/01294/">with a _Drug Role_ evaluated as suspect</a>.

For more information, see <a href="/en/gr/01371/">Enable Company Product Match Verification</a>.

### Duplicate Search Options {#duplicate}

* **Enable Duplicate Search Potential Matches Safety App Page**: When enabled, Vault displays the <a href="/en/gr/01141/#enhanced">enhanced</a> _Potential Matches_ page when users run the <a href="/en/gr/01141/">_Promote to Case_</a> and <a href="/en/gr/760310/">_Duplicate Search on Case_</a> actions. Clear this checkbox to utilize the <a href="/en/gr/01141/#legacy">legacy page</a> in your Vault.
* **Potential Matches for Postmarketing Cases**: Enter the maximum number of spontaneous and postmarketing study _Cases_ to display on the <a href="/en/gr/01141/#potential-matches">_Potential Matches_ page</a>.
* **Potential Matches for Clinical Trial Cases**: Enter the maximum number of clinical trial study _Cases_ to display on the <a href="/en/gr/01141/#potential-matches">_Potential Matches_ page</a>.
* **Enable Possible Matches search for Clinical Trial Cases**: When enabled, during duplicate detection for _Inbox Items_ and _Cases_ with a _Study Type_ of _Clinical Trial_, Vault searches for <a href="/en/gr/01141/#possible">_Possible Matches_</a> in addition to <a href="/en/gr/01141/#id">_ID Matches_</a> and <a href="/en/gr/01141/#subject">_Subject Matches_</a>.
* **Perform Deep Duplicate Search on Inbox Items**: When enabled, during <a href="/en/gr/01141/#overview-of-duplicate-detection">duplicate detection</a>, Vault searches for potential matches in open _Inbox Items_.
* **Index Migrated Cases**: Each time you <a href="/en/gr/01217/">migrate _Cases_</a> into your Vault, select this checkbox to initiate indexing of the new _Cases_. When indexing completes, Vault clears this checkbox.

### Initial Case Options {#initial}

* **Allow Copy Patient Information**: Adds the _New Case - Copy Patient Information_ (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-copy-patient-info-icon.png" alt="copy-patient-info-icon" style="" />) option to the <a href="/en/gr/826980/#complete-the-inbox-item-to-case-compare-page">_Inbox Item to Case Compare_ page</a> during _Inbox Item_ promotion. When users select this option when promoting an _Inbox Item_, Vault generates a new _Case_ <a href="/en/gr/01140/">populated with the patient's details</a>.

### Document Highlighter {#highlighter}

* **Enable Intake Document Highlighter**: Allows users to access the <a href="/en/gr/834442/">_Document Intake Highlighter_ panel</a>.
* **Load Terms for Auto-Extraction**: Allows Vault to reference _Product_ data in your Vault when users run the <a href="/en/gr/834442/#extract">_Extract Company Products_ action</a>. To use this setting, you must select the _Enable Intake Document Highlighter_ checkbox.

### Follow-Up Options {#follow-up-options}

* **Allow follow-up with any matching UID**: Enables users to promote _Inbox Items_ when the Worldwide UID (_WWUID_) does not match but does match another UID, such as an _External System UID_ or a _Case Identifier_. For example, the _WWUID_ of an _Inbox Item_ does not match the _WWUID_ on the initial _Case_, but the _Case Identifier_ of the _Inbox Item_ matches the _WWUID_ of the initial _Case_. If the _Inbox Item_ contains a _WWUID_ value but the matching _Case_ does not, Vault maps the _WWUID_ value to the _Case_ upon promoting it to follow-up.
* **Prohibited States**: Prevents combining _Cases_ in specified lifecycle states with _Inbox Items_ to create _Follow-up Cases_ from the <a href="/en/gr/826980/#complete-the-inbox-item-to-case-compare-page">_Inbox Item to Case Compare_ page</a>.
* **Allow "Ignore All" from specific Origins**: Allows users to ignore all follow-up information from the specified _Organizations_ on the <a href="/en/gr/826980/">_Inbox Item to Case Compare_ page</a>. After you select the checkbox, you can select the applicable _Organizations_.

### Allow Merge Into Active Case {#merge}

* **Merge to Active Case Version**: Adds the _Merge to Current_ (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-merge-to-current-icon.png" alt="Merge to Current Icon" style="" />) option on the <a href="/en/gr/826980/#complete-the-inbox-item-to-case-compare-page">_Inbox Item to Case Compare_ page</a> during _Inbox Item_ promotion.
* **Prohibited States**: Prevents merging _Inbox Items_ into _Cases_ in specified 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 {#mark-follow-up}

* **Allow Mark Follow-up**: Adds the _Mark as Follow Up_ option to the <a href="/en/gr/826980/#complete-the-inbox-item-to-case-compare-page">_Inbox Item to Case Compare_ page</a> during _Inbox Item_ promotion.
* **Prohibited States**: Prevents linking _Cases_ in specified lifecycle states to _Inbox Items_.

## ICSR Reporting Settings {#icsr}

Manage the _ICSR Reporting Settings_ in your Vault:

### Submissions {#submissions}

* **Cancel Auto-Submit for Translations**: <a href="/en/gr/01329/#enable-vault-system-settings">Prevents auto-submissions</a> for _Cases_ with unapproved _Localized Cases_.
* **Suppress File Generation for Auto-Submit Transmissions**: Prevents Vault from generating the <a href="/en/gr/01260/">Auto-Submission</a> document before the initial document. Contact Veeva Managed Services to determine whether you should enable this setting.
* <a id="sub-prod-stud"></a>**Substitute Product/Study for Cross Reporting**: Specify how Vault evaluates the <a href="/en/gr/01250/#product-rule-parameter">_Product_</a>, <a href="/en/gr/01250/#product-family">_Product Family_</a>, and <a href="/en/gr/01250/#study-rule-parameter">_Study_</a> reporting rule parameters during cross reporting.
* <a id="logically-delete"></a>**Logically Delete Non-Submittable Transmissions on Subsequent Evaluations**: Supports the <a href="/en/gr/01327/">logical deletion of non-submittable _Transmissions_</a> after the Safety reporting rule engine re-evaluates reporting obligations on updated _Cases_.
* **One Last Time Reporting for all Destinations**: Configures <a href="/en/gr/01417/">One Last Time (OLT) reporting logic</a> for all reporting destinations with _Transmissions_ in the selected states, regardless of the rule set configuration.
* **One Last Time Reporting for Japan**: Configures <a href="/en/gr/672453/">One Last Time (OLT) reporting logic</a> 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 <a href="/en/gr/696896/#one-last-time-reporting-for-japan-pmda">_Due in Days_</a> 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 <a href="/en/gr/01250/#transmission-reason">rule engine-created _Transmission_</a> is _Initial_ or _Follow-Up_.
* <a id="cr-wo-ds-exp-sub"></a>**Cross Reporting without Datasheet Expectedness Substitution**: Determines how the Safety reporting rule engine evaluates the <a href="/en/gr/01425/">_Expected_ rule parameter for cross reporting scenarios</a> where additional _Products_ are found through a _Substance_ lookup.
* **Strict Transmission Version Enforcement**: When enabled, Vault <a href="/en/gr/716226/">enforces the order</a> in which you are able to send _Transmissions_ via gateway and email to all destinations.
* **Change Localized Case State on Creation**: When enabled, upon _creating a Localized Case_, Vault populates the _Localized Case Creation Method_ field and sets the lifecycle state to the _Ready_ state type.
* **Regenerate Email Transmissions When Submitting to Gateway**: When running the _Submit to Gateway_ action for a <a href="/en/gr/01266/#submit-to-gateway-action">_Case_</a> or <a href="/en/gr/01290/#lc-submit-to-gateway">_Localized Case_</a>, this setting determines whether Vault regenerates _Transmission_ files (except for _Cover Letters_) before sending the _Transmission_.
* <a id="fda-e2br3-tp-olt"></a>**Use FDA E2B(R3) Transmission Profiles for One Last Time Reporting**: When enabled, Vault matches <a href="/en/gr/01248/">One Last Time</a> _Submissions_ to the CBER and CDER postmarket and premarket FDA centers for registrations with FDA E2B(R3) transmission profiles.

## Submission and Distribution Settings {#sub-dist}

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      <p><strong>Note</strong>: You should not enable the <strong>Use Adverse Event PT on CIOMS and MedWatch 3500A</strong> setting if you have enabled the <strong>Use Product(Reported) Name on CIOMS and MedWatch 3500A</strong> setting in your Vault.</p>
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### Transmission Document Export Settings {#transmission-doc}

* <a id="mask-reporter"></a>**Mask Reporter For PM Non-Literature Case**: When enabled, Vault <a href="/en/gr/01225/#reporter-masking-for-postmarket-non-literature-cases">masks reporter information</a> in all outbound _Submissions_ and _Distributions_ for postmarket non-literature _Cases_. Once enabled, reporter masking applies to all postmarket non-literature _Cases_, regardless of the masking settings on _Transmissions_.
* **Export IMDRF Codes on MedWatch 3500A**: When enabled, Vault <a href="/en/gr/01373/">exports International Medical Device Regulators Forum (IMDRF) device codes</a> instead of FDA device codes to FDA MedWatch 3500A and FDA eMDR files.
* **Use Adverse Event PT on CIOMS and MedWatch 3500A**: When enabled, Vault <a href="/en/gr/01426/">displays adverse events using MedDRA Preferred Term (PTs)</a> on CIOMS I, FDA MedWatch 3500A, and FDA eMDR files.
* <a id="code-pr"></a>**Use Product(Reported) Name on CIOMS and MedWatch 3500A**: Defines whether Vault <a href="/en/gr/01403/">exports reported or coded _Products_</a> by default on CIOMS I, FDA MedWatch 3500A, and FDA eMDR files.
* <a id="mask-dosage"></a>**Mask Dosage on Blinded Forms**: When enabled, Vault <a href="/en/gr/01420/">masks dosages</a> in blinded report previews and masked _Distributions_.
* <a id="display-unmasked"></a>**Display Unmasked Open-label Products on Blinded CIOMS and MedWatch 3500A**: When enabled, Vault always <a href="/en/gr/01406/">unmasks open-label _Products_ within blinded _Studies_</a> on blinded CIOMS I, FDA MedWatch 3500A, and FDA eMDR files.
* **PMDA E2B: Do not export UCUM code not supported by PMDA**: <a href="/en/gr/714862/">Prevents exporting</a> 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 <a href="/en/gr/696896/#prevent-export-of-unsupported-ucum-codes">export `{DF}`</a> 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.
* <a id="coded-hc"></a>**Use Product Coded for HC E2B(R2)**: When enabled:
    * For all _Case Products_ Vault exports coded <a href="/en/gr/700011/#prod-export">_Product_</a> names. If coded values are blank or you do not enable this setting, Vault exports reported values.
    * For non-<em>External Products</em>, Vault exports the <a href="/en/gr/700011/#prod-export">_Name_</a> of the related _Product_ for _Study Products_ and _Product Constituents_ of _Combination Products_. If you do not enable this setting, Vault exports the _Name_ of _Study Products_ and the _Product Name_ of _Combination Products_.
* <a id="initial-reason"></a>**Set Transmission Reason to Initial for Migrated Cases**: When generating _Transmissions_, including for follow-ups to imported _Cases_, if there is no previous _Transmission_ for a _Case_ to a destination, Vault populates `Initial` as the <a href="/en/gr/1022564/#transmission-reason">_Reason_</a> on the _Transmission_.
* <a id="rpt-lcl-event-in-ntv-lang"></a>**Deferred Domestic Processing: Localized Event Reported in Native Language**: When generating E2B files for all supported agencies except the PMDA, export the _Localized Case Adverse Event_ field _Event (Reported)_ to E.i.1.1a (Event Reported in Native Language) and E.i.1.1b (Localization Language) E2B(R3) fields and B.2.i.0 E2B(R2) field.
* <a id="secure-dtd-ema-e2b"></a>**Use secure DTD for EMA E2B submissions**: When validating _Transmission Documents_ for the EMA, use a secure HTTPS URL to the EMA's Document Type Definition (DTD).
* <a id="study-type"></a>**Use ICH Update Study Type Code List in E2B(R3) Export**: Designates which E2B(R3) formats and regulatory agency pairs include additional <a href="/en/gr/01195/#study-type">_Study Type_</a> values based on the ICH E2D(R1) guidelines.

## Safety Security Settings {#security}

Manage the _Safety Security Settings_ in your Vault:

### Case Access Groups {#cag}

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      <p><strong>Note</strong>: Contact your Veeva representative before enabling these settings in your Vault</p>
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* **Enable Case Access Groups**: Enables the <a href="/en/gr/01304/">Case Access Group Security feature</a>.
* **Secure Users by Case Access Group**: Limits the visibility of Vault users to each other by <a href="/en/gr/01182/">_Case Access Group_</a>.

#### Blind Protection {#blind}

* **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 {#lock}

* **Enable Strict Case Locking**: <a href="/en/gr/01170/#strict-case-locking">Restricts editing</a> _Cases_ and _Case_-descendant objects to only the user identified in the _Locked By_ field on an applicable _Case_.
  * **Excepted Fields**: Identifies <a href="/en/gr/01170/#strict-case-locking">_Case_ fields that remain editable</a> to users, regardless of the _Locked By_ field setting.

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      <p><strong>Note</strong>: In Vaults with strict <em>Case</em> locking enabled, Vault prevents conflicting <em>Case</em> edits in a number of user-initiated scenarios. To learn more, see <a href="/en/gr/788754/#user-initiated-scenarios">Manage Strict Case Locking</a>.</p>
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### Other Options {#security-other}

* **Mask PHI and PII on the Potential Matches Page**: When enabled, Vault <a href="/en/gr/01346/">masks</a> protected health information (PHI) and personally identifiable information (PII) on the <a href="/en/gr/01141/#page">_Potential Matches_ page</a> during duplicate detection.

## Safety General Settings {#general}

Manage the _Safety General Settings_ in your Vault:

### Date/Time Options {#date-time}

* **Allow partial date entry for Case Product Expiration, Implanted Date, Explanted Date, Returned Date**: Allows Case Processors to <a href="/en/gr/01409/">enter partial dates</a> in _Case Product_ device fields.

### Auto-calculation Settings {#auto-calc}

* **Allow manual override of auto-calculated fields**: Allows users to <a href="/en/gr/01377/">override Vault auto-calculations</a> and manually enter data in certain fields.
* **Reset Dechallenge Override on Dechallenge recalculation**: When enabled, Vault clears the _Dechallenge Override_ field on _Case Assessments_ following <a href="/en/gr/935474/#recalculations">_Dechallenge_ recalculations</a>.
* **Only Case Assessments associated with a Clinical Trial study type will be tagged as SUSAR**: If enabled, Vault <a href="/en/gr/01156/#susar-tag">assigns _SUSAR_ tags</a> to _Case Assessments_ only on clinical trial study _Cases_.
* **Adverse Event Ranking Order**: Defines the priority of _Case_ fields that Vault evaluates when <a href="/en/gr/881477/">assigning ranks to _Case Adverse Events_</a>.
* **Related Case Identifier source (On Edit)**: Defines whether Vault updates the <a href="/en/gr/01287/#related-case-id">_Related Case Identifier_ field</a> on _Case Relationship_ records with the _UID_ or the _Worldwide UID_ of the related _Case_ following changes to the _Related Case_ value.

### Domestic Cases {#domestic-cases}

* **Enable auto-set Inbox Item Localization by Reporter Country**: When enabled, Vault automatically <a href="/en/gr/01329/#enable-vault-system-settings">sets _Inbox Item_ localization</a> based on reporter locale.
* **Enable State/Province Selector**: When enabled, Vault references the _Country State/Province_ library for <a href="/en/gr/01168/#domestic-state-code">domestic state code mapping</a>.
* **Enable Localization-based Mapping on Import**: Enables importing <a href="/en/gr/01335/">local _Cases_ to _Inbox Items_</a> from an E2B or Intake Vault API source. You can also specify this behavior at a granular level for individual <a href="/en/gr/01202/#fields">_Transmission Profiles_</a> and <a href="/en/gr/01211/#tabular-data">_Tabular Data Formats_</a>, which overrides this setting for the associated imported files. <a href="/en/gr/735519/">PMDA import</a> ignores this setting.

### Metrics

#### Case Volume Metrics {#case-volume}

* **Frequency**: Defines whether Vault runs the <a href="/en/gr/01292/">_Case Volume Metrics_ job</a> hourly or daily.
* **Case Initial**: Defines the _Case_ lifecycle states Vault considers as initial when running the <a href="/en/gr/01292/">_Case Volume Metrics_ job</a>.
* **Case Active**: Defines the _Case_ lifecycle states Vault considers as active when running the <a href="/en/gr/01292/">_Case Volume Metrics_ job</a>.
* **Case Completed**: Defines the _Case_ lifecycle states Vault considers as completed when running the <a href="/en/gr/01292/">_Case Volume Metrics_ job</a>.

### Other Options {#metrics-other}

* **Allow localized record deletion from Case**: Allows users to <a href="/en/gr/01396/">delete localized child and grandchild records</a> when deleting the global _Case_ children.
* **Extend Suspect Definition to Include Drug Not Administered**: Defines whether <a href="/en/gr/01294/">Vault evaluates</a> _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 <a href="/en/gr/691318/">isolate blinded product information for Clinical Trial _Study Cases_</a>. 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 <a href="/en/gr/654889/">updates the _Case_- and _Adverse Event_-level _Seriousness_ picklists</a> to include _Required Intervention to Prevent Permanent Impairment/Damage (Devices)_.
* **Turn off Blind Protection on Narrative**: Turns off blind protection on <a href="/en/gr/01167/#doc-fields">generated narrative documents</a>.
* **Capture additional date fields on case versions for reporting/analytics**: When enabled, on superseded _Cases_, Vault links to the next _Case_ version and maps its _New Info Date_ and _Approval Date_. After mapping this information to the superseded _Case_, Vault also updates its _Last Modified Date_.
* **Default to previous case version narrative on follow-up**: When enabled in Vaults using <a href="/en/gr/832806/#settings">rules based narratives</a>, Vault only copies narratives from previous _Case_ versions to follow-up _Cases_ upon promotion and does not generate new versions based on applicable outline templates.
* <a id ="use-unknown-formulation-products-setting"></a>**Use Unknown Formulation Products**: When enabled, Vault supports <a href="/en/gr/931735/">_Products_ with unknown formulations</a>.

### Auto-generate Assessments {#auto-gen-assessments}

* **Generate Assessments for both Serious and Non-Serious Adverse Events**: Enables Case Processors to generate _Assessments_, _Assessment Results_, and _Expectedness_ records for all <a href="/en/gr/01305/">serious and non-serious _Adverse Events_</a> on a _Case_.
* **Exclude External Products when Generating Assessments**: When enabled, Vault <a href="/en/gr/01169/#exclude-external">excludes _External Products_</a> and considers only _Company Products_ when generating _Case Assessments_ for both postmarket and clinical trial _Cases_. Upon configuration, this behavior applies only to subsequent assessment generation. To exclude _External Products_ for postmarket _Cases_ only, enable the _Continue generating assessments for Clinical Trial cases_ sub-setting.
    * **Continue generating assessments for Clinical Trial cases**: When enabled, Vault considers both _External Products_ and _Company Products_ when generating _Case Assessments_ for clinical trial _Cases_. Upon configuration, this behavior applies only to subsequent assessment generation. This setting does not impact assessment generation on postmarket _Cases_.
* **Recalculate Post-Market Expectedness on Follow-up**: When enabled, following merge to an in-flight _Case_ or promotion to a follow-up _Case_, Vault <a href="/en/gr/737264/#follow-up-expectedness">reevaluates postmarket _Case_ expectedness</a> based on the new information.
* **Calculate Clinical Trial Case Expectedness using "Based On" field**: When enabled, Vault <a href="/en/gr/737256/">calculates expectedness on Clinical Trial _Study Cases_</a> using _Adverse Event Onset_ date or _Case New Info Date_, depending on the _Based On_ setting for each _Agency_.
* <a id="device-contituent-case-assessments"></a>**Enable Device Constituent Case Assessments**: When enabled, Vault creates records for all device constituents of combination products upon <a href="/en/gr/01169/">_assessment generation_</a>. For Japan localized cases, Vault creates _Local Reporting Details_ and _Case Product Registration_ records for all device constituents of combination products.

### Post-Closure Quality Control {#qc}

* **Post-Closure QC Interval**: Defines the interval at which Vault identifies closed _Cases_ for post-closure <a href="/en/gr/679958/">QC checklist generation</a>.

## Aggregate Report Settings {#aggregate}

Manage the _Aggregate Report Settings_ in your Vault:

### Aggregate Report Authoring {#authoring}

* **Generate Tabulations Using Sections**: Allows users to <a href="/en/gr/681638/">generate and manage tabulations</a> using _Aggregate Report Sections_.

### CIOMS II

* **Allow Narrative Preview to be included in the report**: Defines whether <a href="/en/gr/01397/">_Narrative Previews_</a> are included in CIOMS II reports.

### DSUR / PBRER {#dsur-pbrer}

* **Only Include Investigational Products for SAR**: When enabled, Vault considers only <a href="/en/gr/01381/">causal assessments related to investigational _Products_</a> for inclusion in Safety DSURs and PBRERs.
* **Use templates with calculated totals for tabulations, once uploaded**: When enabled, Vault displays summary and grand totals in <a href="/en/gr/01418/">Safety DSUR and PBRER tabulations</a> and generates log files in a separate _Log_ file.
* **Display Assessment Results and Case Totals on SAR Line Listings**: When enabled, Vault <a href="/en/gr/01293/">displays _Case Assessment Results_ and _Case_ subtotals and grand totals</a> on Safety DSUR and PBRER Interval Line Listings of Serious Adverse Reactions.
* **Display additional fatal events in Cause of Death on List of Subjects Who Died**: When enabled, the Cause of Death column of the _List of Subjects Who Died_ tabulation on the <a href="/en/gr/01280/#appendix-list-of-subjects-who-died-during-the-reporting-period">Safety DSUR</a> includes all _Adverse Event_ records on the _Case_ with a _Seriousness_ of _Results in Death_ or an _Outcome_ of _fatal_, in addition to the _Cause of Death_ records on the _Case_.

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      <p><strong>Note</strong>: Workbench DSUR and PBRER aggregate reports behave as if the following settings are enabled:</p>
<ul>
  <li><strong>Only Include Investigational Products for SAR</strong></li>
  <li><strong>Use templates with calculated totals for tabulations, once uploaded</strong></li>
</ul>

<p>Additionally, Workbench DSURs and PBRERs include assessment results, but not <em>Case</em> totals, in SAR Line Listings.</p>
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### PSUR

* **Use template with calculated totals for tabulations, once uploaded**: When enabled, Vault adds <a href="/en/gr/01299/">summary and grand totals to PSUR tabulations</a> and generates the Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions Logs in a separate _Log_ file.

## Safety Rules Troubleshooting {#troubleshooting}

Use the <a href="/en/gr/659226/">Safety Rules Troubleshooting tool</a> to diagnose and fix issues when Safety reporting rules, including custom rules, are failing.

## SafetyDocs Settings {#safetydocs}

Manage the _SafetyDocs Settings_ in your Vault:

### PSMF
* <a id="assign-psmf-review-tasks"></a>**Assign PSMF Review tasks to multiple users**: When enabled, Vault can assign <a href="/en/gr/01241/#create-psmf-document-review">_PSMF Document Review_</a> tasks to the document or binder _Owner_ as well as any users with the _PSMF Periodic Review SME_ role for the document or binder.
    * <a id="outcome-handling"></a>**Periodic Review Outcome Handling for Multiple Reviewers**: Determines when the document is up-versioned and how remaining open <a href="/en/gr/01241/#review">review tasks</a> are handled. This setting appears only after you enable the _Assign PSMF Review tasks to multiple users_ setting.
* **PSMF Logbook Ordering**: Defines whether <a href="/en/gr/714076/">_PSMF Logbook Entries_</a> are ordered by date of entry or by section and annex.
* <a id="limit-logbook-comments"></a>**Limit Logbook Comment Edits to Comment Author**: When enabled, only the user specified in the _Person Making Change_ field of a <a href="/en/gr/01277/#psmf-logbook">_PSMF Logbook Entry_</a> can edit or delete the record.
* <a id="table-of-contents-label"></a> **PSMF Table of Contents Label Field**: Defines the value Vault displays for document names in <a href="/en/gr/01277/#psmf-table-of-contents">_PSMF Table of Contents_</a>.

### Literature

* **Load Terms for Abstract Highlighting**: Allows Vault to <a href="/en/gr/01318/#25r1-update-highlight-literature-abstract-terms">automatically highlight relevant terms</a> in the _Abstract_ field of _Literature Article_ records.
