**Source URL:** https://safety.veevavault.help/en/lr/01169/index.md # Generate Assessments When entering data on a _Case_, the _Medical Assessments_ section displays the assessed relationship between _Case Adverse Events_ and _Case Products_ with an [eligible _Drug Role_][2]. For each _Case Adverse Event_ and eligible _Case Product_ pair, there can be only one _Case Assessment_. For each _Case Assessment_, Vault generates two [_Case Assessment Results_][5]. Except for [Product Quality Complaints (PQCs)][7], Vault generates _Case Assessments_ for the following pairs: * All serious _Case Adverse Events_ paired with _Case Products_ with an [eligible drug role][2] * Primary non-serious _Case Adverse Events_ paired with primary _Case Products_ with an [eligible drug role][2] Depending on your Admin's configuration, Vault can generate _Case Assessments_ in the following ways: * **Auto-generated:** Vault generates _Case Assessments_ based on new or changed information. * **Generate Assessments Action:** You run the _Generate Assessments_ action to generate all new and missing _Case Assessments_ at once. * **Manual Case Assessment Creation:** You [manually create][6] individual _Case Assessments_. For information on _Localized Case Assessment_ generation when processing _Cases_ that may be reportable to the PMDA, see Complete Intake and Process Cases for the PMDA. ### Prerequisites To use this feature, your Admin must enable Generate Assessments Record Action. To base adverse event expectedness evaluations on _Agency_ configuration for clinical trial study _Cases_, your Admin can also enable Agency-Based Auto-Expectedness for Clinical Trial Study Cases. For Vault to create _Case Assessments_ for combination _Case Products_ with constituent _Devices_, your Admin can enable Device Case Assessments & ICSR Transmissions. ## Case Products and Assessments {#drug-role} Your Admin can configure assessment generation: * Based on [_Drug Role_][8] * To exclude [_External Products_][9] * To include [constituent _Devices_][10] ### Drug Roles Considered {#drug-roles-considered} When generating assessments, Vault always considers _Case Products_ with a _Drug Role_ of _Suspect_ or _Interacting_. Your Admin can also configure your Vault to consider _Case Products_ with a _Drug Role_ of _Drug Not Administered_ during assessment generation. ### External Products Excluded {#exclude-external} To reduce the overgeneration of assessments, your Admin can configure your Vault to exclude _External Products_ when generating assessments. Depending on your Admin's configuration, Vault does not generate assessments for _External Products_ on postmarket and clinical trial study _Cases_, or only on postmarket _Cases_. Upon configuration, the change applies only to subsequent assessment generation. Vault does not delete previously existing assessments in the following scenarios: * For _External Products_ on existing _Cases_, including if the _External Product_ is changed to a _Company Product_. * When generating new assessments for previously existing _External Products_ on follow-up _Cases_. However, Vault will not generate assessments for new _External Products_, products with no previously generated assessments, on follow-ups.

Note: For E2B-imported Cases, Vault imports assessments for External Products from the source file.

### Constituent Devices Considered {#const-devices-considered} Your Admin can configure your Vault to generate assessments for each _Device_ constituent of a combination _Case Product_ and _Case Adverse Event_ pair. ## Case Assessment Generation and Evaluation {#when-generated} When Vault generates _Case Assessments_ automatically or you run the _Generate Assessments_ action, Vault generates _Case Assessments_, _Case Assessment Results_, and _Case Assessment Expectedness_ records for _Case Adverse Event_ and _Case Product_ pairs, if they don't already exist. Vault generates _Case Assessments_ for: * All serious _Case Adverse Events_ paired with _Case Products_ that have an [eligible _Drug Role_ or _Product Type_][2], including constituent _Devices_ if configured by your Admin * Primary non-serious _Case Adverse Events_ paired with primary _Case Products_ that have an [eligible _Drug Role_ or _Product Type_][2], including constituent _Devices_, if configured by your Admin Vault generates a single assessment for [Product Quality Complaints (PQCs)][7]. In Vaults with strict _Case_ locking enabled, the _Generate Assessments_ action locks the _Case_ while the action is running. When generating _Case Assessments_, Vault also considers whether the _Case_ is initial, in-flight, or a follow-up and whether the _Case_ is for a clinical trial study or a postmarket product. To evaluate adverse event expectedness on clinical trial study _Cases_, Vault considers the active date range of the _Adverse Event_ on the applicable _Datasheet_. Vault does not consider the active date range for applicable _Datasheets_ associated with the _Company Product_. For global _Cases_ with associated domestic _Cases_, generated and updated _Case Assessments_, _Case Assessment Results_, and _Case Assessment Expectedness_ records are synced across _Case_ versions.

Note: You cannot edit Cases during Case Assessment generation.

### Case Assessment Generation After Inbox Item Promotion For all initial _Cases_, Vault generates new assessments when an _Inbox Item_ is promoted to a _Case_. When promoting an _Inbox Item_ to a follow-up _Case_ or merging to an in-flight _Case_: * Vault generates _Case Assessments_ for new or changed _Case Products_ or _Case Adverse Events_. For example, when a _Case Product_ with an [eligible drug role][2] is added, Vault generates _Case Assessments_ for the new _Case Adverse Event_ and _Case Product_ pairs. * Vault reevaluates _Case Assessments_ for all modified _Case Adverse Events_ or _Case Products_. * For existing _Case Adverse Events_ without changes, Vault reevaluates _Case Assessments_ for _Cases_ with postmarket products only. Vault does not reevaluate _Case Assessments_ for existing _Case Adverse Events_ on clinical trial study _Cases_. * For promoted _Inbox Items_ generated from imported E2B XML files with assessments that are not mapped to adverse events, Vault generates unknown (UNK) _Case Assessments_ for the _Case_. In Vaults with the _Generate Assessments for both Serious and Non-Serious Adverse Events_ application setting enabled, when Vault cannot generate _Case Assessments_ during _Case_ promotion, Vault promotes the _Inbox Item_ and creates the _Case_ with no _Case Assessments_. To generate all _Case Assessments_, _Case Assessment Results_, and _Case Assessment Expectedness_ records for _Case Adverse Event_ and _Case Product_ pairs, from the **All Actions** menu, select **Generate Assessments**. ### Case Assessment Reevaluation When existing _Case Assessments_ are reevaluated, Vault updates associated _Case Assessment Result_, and _Case Assessment Expectedness_ records and recalculates roll-ups. Updates happen in the following instances: * For _Case Adverse Events_: * The _MedDRA LLT_ changes * The _Seriousness_ changes * The _Rank_ of a non-serious _Case Adverse Event_ changes to 1 * The onset date of the _Case Adverse Event_ is added, updated, or removed * For _Case Products_: * The _Product_ changes * The _Drug Role_ changes to an [eligible drug role][2] * The _Rank_ changes to 1 * The _Indication_ is added or changed * For _Patients_: * The age is added, updated, or removed * The sex is added, updated, or removed

Note: The following list outlines instances when Case Assessments or related records are not updated:

Existing Case Assessments are not deleted when the associated Drug Role changes from an eligible drug role to another Drug Role.
Manually created or overridden Case Assessment Expectedness records are not updated when the seriousness changes from non-serious to serious.
Case Assessment Expectedness records are not updated when the Rank of a non-serious Case Adverse Event changes to 1.

### Product Quality Complaint (PQC) Assessments {#pqc-assessments} Vault supports classifying _Case Adverse Events_ as _Product Quality Complaints_ and identifying the related _PQC Product_ on the event. When generating assessments for _Product Quality Complaints_, Vault generates one assessment for the _Case Adverse Event_ and _PQC Product_ pair. The assessment includes one _Case Assessment_, two _Case Assessment Result_ records and the relevant _Case Assessment Expectedness_ records. If a _Case Adverse Event_ includes _Product Quality Complaint_ in the _Type_ field, but the _PQC Product_ field is blank, Vault does not generate an assessment for that adverse event. Unlike for non-PQC adverse events, Vault does not generate additional assessments that pair that _Case Adverse Event_ with each _Case Product_. #### PQC Assessment Regeneration When you update information on a _Case Adverse Event_, Vault regenerates assessments as follows: * If you update the _Type_ so it is no longer _Product Quality Complaint_, Vault deletes the assessment for the _PQC Product_ and [generates assessments][1] for that _Case Adverse Event_ paired with each _Case Product_. * If you update the _Type_ to _Product Quality Complaint_, Vault deletes any assessments for that _Case Adverse Event_ paired with _Case Products_ and generates an assessment for the _PQC Product_. Vault populates _Yes_ in the _Potential PQC_ field on the _Case Assessment_. * If you clear the _PQC Product_, Vault deletes the assessment for the _PQC Product_. * If you update the _PQC Product_, Vault deletes the assessment for the original _PQC Product_ and generates a new assessment for the updated _PQC Product_. * If the MedDRA code for the _Case Adverse Event_ changes upon follow-up, Vault updates the _Event (LLT)_ on the PQC _Case Assessment_ and reevaluates the _Expected_ value. ## Clinical Trial Study Case Considerations Your Admin may configure the following features for working with expectedness on clinical trial study _Cases_: * [Expectedness evaluations on clinical trial study _Cases_ by _Agency_][3] * [Expectedness generation for blinded _Study Products_ on blinded study _Cases_][4] ### Clinical Trial Study Case Expectedness by Agency {#ct-expectedness} If your Admin enables Agency-Based Auto-Expectedness for Clinical Trial Study Cases, Vault does not automatically recalculate expectedness on in-progress study _Cases_. For clinical trial study _Cases_ with a _Study_ registered with an _Agency_ set to calculate expectedness based on _New Info Date_, you must run the _Generate Assessments_ action to update evaluations. For more information, see Expectedness Evaluations for Clinical Trial Study Cases.

Note: On Cases where Expectedness records exist based on both Adverse Event Onset dates and Case New Info Dates, if you delete one partner in the pair, when you run the Generate Assessments action Vault regenerates the deleted records.

### Clinical Trial Blinded Study Product Expectedness {#blinded-sp-expectedness} If your Admin enables Datasheet Expectedness for Blinded Study Products, Vault generates expectedness for blinded _Study Products_ on blinded _Cases_. This feature is supported only for double-blinded clinical trial _Studies_ without _Study Arms_. For more information, see Expectedness Evaluations for Clinical Trial Study Cases. In addition to these [_Adverse Event_ and _Case Product_ triggers][1], when an existing _Blinded Name_ is edited, Vault updates related _Case Assessment_, _Case Assessment Result_, and _Expectedness_ records. ## Case Assessment Result Source Types {#car-source} When Vault generates a _Case Assessment_, it also generates two child _Case Assessment Results_ as placeholders: one for the company and one for the primary reporter. Vault assigns the _Source Type_ for _Case Assessment Results_ using the logic described in the following sections. The _Source Type_ field refers to the Case Assessment Source Controlled Vocabulary. ### Clinical Trial Cases For clinical trial _Cases_ and for study _Cases_ where the _Study Type_ is blank, Vault generates _Case Assessment Results_ with the following _Source Types_:

Case Assessment Result Placeholder	Source Type	E2B Code¹
Company	Sponsor	`2`
Reporter	Investigator	`1`
E2B Code refers to the value in the `e2b_code__v` field on the Controlled Vocabulary corresponding to the Source Type field.

### Postmarket Cases For _Spontaneous_ and _Postmarket Study Cases_, Vault generates _Case Assessment Results_ with the _Source Types_ shown in the table below:

Note: For postmarket cases, the primary Reporter type of Case Contact is referenced to determine the Source Type. If the primary Reporter type of Case Contact does not specify a Qualification, Vault-generated Case Assessment Result for the Reporter is not assigned a Source Type.

Case Assessment Result Placeholder	Qualified HCP?¹	Source Type	E2B Code²
Company	n/a	Market Authorization Holder (MAH)	`4`
Reporter	Yes	Health Care Professional	`5`
Reporter	No	Non-Health Care Professional	`6`
Whether the Qualification selected on the primary Reporter type of Case Contact corresponds to a Qualification Controlled Vocabulary where Qualified HCP is Yes. E2B Code refers to the value in the `e2b_code__v` field on the Controlled Vocabulary corresponding to the Source Type field.

## Refresh Assessments When assessment generation is initiated, a banner appears either at the top of the _Assessments_ section or at the top of your browser window, depending on how the action was initiated. Click the link in the banner to refresh the information displayed and see the most up-to-date _Case Assessments_ and related records. ## Case Name and Field Updates When assessment generation is complete, if needed, Vault updates the _Case Name_. Vault recalculates the following system-calculated fields if they have not been overridden: * _Case Tags_ * _Expected (status)_ * _Expectedness_ * _Listedness (core)_ * _Listedness (status)_ * _Relatedness_ * _Serious_ * _Seriousness_ * _Watchlist Tags_

Note: If any validation errors occur while generating Case Assessments, Vault does not update or generate any Case Assessments. Instead, Vault generates a notification that includes a CSV file that describes all errors.

## When Case Assessments Cannot Be Generated _Case Assessments_ cannot be generated when _Cases_ are in the following states: * _Approved_ * _Closed_ * _Duplicate_ * _Inactive_ * _Invalid_ * _Nullified/Nullifying_ * _Rejected_ * _Superseded_ * _Void/Voiding_ ## Adding Assessments Manually {#add-car} While Vault automatically generates _Case Assessments_ and _Case Assessment Results_, you may need to add them manually, for example, if you accidentally delete a Vault-generated assessment. 1. On the _Case_, expand the _Case Assessments_ or _Case Assessments Result_ section. 2. Select **Create**. 3. For _Case Assessments_: 1. On the _Create Case Assessment_ page, in the **Case Product** field, select the suspect product. 2. In the **Case Adverse Event** field, select the relevant adverse event. 4. Complete the applicable _Case Assessment_ or _Case Assessment Result_ fields. 5. Select **Save** [1]: #when-generated [2]: #drug-role [3]: #ct-expectedness [4]: #blinded-sp-expectedness [5]: #car-source [6]: #add-car [7]: #pqc-assessments [8]: #drug-roles-considered [9]: #exclude-external [10]: #const-devices-considered