# Configure Controlled Vocabularies

_Controlled Vocabularies_ contain standard ICH-based terminologies used to describe or code information in a Vault Safety _Case_. _Controlled Vocabularies_ impact how users can enter data in Vault Safety and how information is recorded and transferred in accordance with E2B and ICH standards. 

Vault comes with standard and preconfigured _Controlled Vocabularies_ with varying levels of configurability. _Controlled Vocabularies_ with E2B mapping defaults have the highest level of protection to ensure data can easily flow in and out of Vault during E2B import and exports, followed by _Controlled Vocabularies_ related to feature functionality. 

For standard Vault-managed _Controlled Vocabularies_, you can edit only the _Name_. All other fields are protected. However, you can add custom _Controlled Vocabularies_, which can be completely customized by administrators. Once a custom _Controlled Vocabulary_ is in use, Vault protects it from deletion to maintain data integrity. If a custom _Controlled Vocabulary_ becomes obsolete, you can [deprecate it][1].

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      <p><strong>Note</strong>: You can tell the difference between standard and custom <em>Controlled Vocabularies</em> by looking at the <em>API Name</em>. Standard <em>Controlled Vocabularies</em> have <em>API Names</em> ending with <code class="language-plaintext highlighter-rouge">__v</code>.</p>
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## Configure Controlled Vocabularies

1. Navigate to **Business Admin > Objects > Controlled Vocabularies**.
2. On the **Controlled Vocabularies** page, perform one of the following actions:
    * To add a new Controlled Vocabulary, select **Create**.
    * To edit an existing Controlled Vocabulary, open the record, and then select **Edit**.
3. Complete the **Create Controlled Vocabulary** window.
4. Save the page.

## Common Controlled Vocabulary Fields

The following table describes the default Controlled Vocabularies fields that appear on all Controlled Vocabulary object types. Certain fields appear only for certain Controlled Vocabulary types, which are described along with the [types][2] below. 

<table>
    <thead>
        <tr>
            <th>Field Name</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Type</td>
            <td>The Controlled Vocabulary object type. The default <a href="#types">Controlled Vocabulary types</a> are described below.</td>
        </tr>
        <tr>
            <td>Name</td>
            <td>The label for the Controlled Vocabulary record. You can edit this field for standard system-provided Controlled Vocabularies.</td>
        </tr>
        <tr>
            <td>E2B Default Value</td>
            <td><p>Set this field to <strong>Yes</strong> for a Controlled Vocabulary with an associated E2B default code that Vault Safety should map to during an E2B import.</p>
                <p><a href="/en/gr/01134/">E2B Case Import Data Mapping</a> describes how Vault Safety imports E2B data to a Case.</p> 
                <p>You cannot edit this field for records with an API Name ending in <code>__v</code>. You cannot set this field to <strong>Yes</strong> for custom records.</p></td>
        </tr>
        <tr>
            <td>E2B Code</td>
            <td><p>The E2B Code specifies the E2B value that a Controlled Vocabulary maps to for E2B export. You should always populate this field to ensure your E2B exports contain the valid mapping for your custom Controlled Vocabularies.</p>
                <p><a href="/en/gr/01288/">E2B Generation Data Mapping</a> describes how Vault Safety exports Case data to an E2B file.</p>
                <p>For records with an API Name ending in <code>__v</code>, you can only edit this field when the <strong>E2B Default Value</strong> field is set to <strong>No</strong> or is blank.</p>
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      <p><strong>Note</strong>: Vault’s Controlled Vocabularies only capture E2B R3 codes. Vault will automatically detect and convert captured E2B R3 codes to the E2B R2 format when you generate an E2B R2 transmission.</p>
    </div>
  </div>
</div>

</p></td>
        </tr>
        <tr>
            <td>API Name</td>
            <td><p>Vault name for the record. You can tell whether a record is standard or custom from the API name. If the name ends with <code>__c</code>, it is a custom record. If the name ends with <code>__v</code>, it is a standard record.</p> 
                <p>You cannot edit this field for records with an API Name ending in <code>__v</code>. You cannot add an API Name ending in <code>__v</code> for a custom record.</p></td>
        </tr>
        <tr>
            <td>Status</td>
            <td><p>The Status field determines whether a Controlled Vocabulary is active, deprecated, or inactive. Inactive records are not available for use. <a href="#deprecated-cv">Deprecating records</a> prevents future use of the term, while still allowing users to look back at the historic usage of the term.</p>
                <p>You cannot modify this field in the edit view. You can only edit the Status through a <a href="#deactivate-cv">user action</a> on the Controlled Vocabulary.</p>
                <p>For records with an API Name ending in <code>__v</code>, you can only edit this field when the <strong>E2B Default Value</strong> field is set to <strong>No</strong> or is blank.</p></td>
        </tr>
    </tbody>
</table>

## Deprecated Controlled Vocabularies {#deprecated-cv}

Deprecated Controlled Vocabularies are Controlled Vocabularies that a user no longer wants to support or use in Vault Safety. When you deprecate a Controlled Vocabulary, you prevent future use of the term by any user, while still allowing users to look back at the historic usage of the term.

### Import Cases With Deprecated Controlled Vocabularies

When an E2B case contains terms that match deprecated Controlled Vocabularies in Vault Safety, you can import the Case from another system into Vault Safety. Once you import the Case with deprecated Controlled Vocabularies, you can still view the deprecated terms. 
 
If you promote an Inbox Item or add a Follow-up Case with deprecated Controlled Vocabularies, these deprecated terms are copied over. 
<a id="deactivate-cv"></a>
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      <p><strong>Note</strong>: While editing an Inbox Item or Case, if you replace a deprecated Controlled Vocabulary by selecting a new term in the picklist, the deprecated term will no longer appear in the picklist.</p>
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### Deprecate a Controlled Vocabulary

Admins can deprecate custom Controlled Vocabularies in the Active or Inactive state. System-managed Controlled Vocabularies cannot be deprecated.

1. Navigate to **Business Admin > Objects > Controlled Vocabularies**.
2. Hover over the Controlled Vocabulary record to which you want to deprecate.
3. Select the **All Actions** menu that appears next to the term, and then select **Change State to Deprecated**.

**Result**

The Controlled Vocabulary is deprecated and is identified with a deprecated badge: <img class="inline" src="https://platform.veevavault.help/assets/images/saf-deprecated-badge.png" alt="Deprecated-Badge" style=" width: 4rem;" /> 

This term is unavailable for future use but users can still look back and view any pre-existing references to the deprecated Controlled Vocabulary.

### View Deprecated Controlled Vocabularies

To view the list of deprecated terms, you can go to the **Controlled Vocabularies** page, and filter by Lifecycle State to find terms in the **Deprecated** state.

Admins can still edit Inbox Items and Cases that use deprecated terms if needed.

## Controlled Vocabulary Types {#types}

Vault Safety includes the following Controlled Vocabularies out-of-box.

### Anatomical Site {#anatomical-site}

This Controlled Vocabulary type determines what options users can select in the **Anatomical Approach Site** when entering dosage information for a vaccine on a Case Product Dosage record. This Controlled Vocabulary maps to FDA VAERS E2B(R3) data element **FDA.G.k.4.r.12 Vaccine Anatomical Approach Site**.

### Age Group {#age-group}

This Controlled Vocabulary type determines which options users can select in the **Age Group** field for entering patient information on a Case. This Controlled Vocabulary maps to:

* **E2B(R3)**: D.2.3 Patient Age Group (as per reporter)
* **PMDA MHLW Paper Form**: Detail Form 2-2, D.2.3 Patient Age Group (as per reporter)

When a Case doesn't include the Patient's Date of Birth and Age at Onset, Vault maps adverse events to the Age Range for Expected and Unexpected MedDRA Criteria on Datasheets using the Patient's Age Group. In this scenario, the Patient Age Group must fall entirely within the Age Range on the Datasheet.

### Action Taken {#action-taken}

This _Controlled Vocabulary_ determines the available _Action Taken_ values on _Case Products_ and maps to the following reports and data elements:

* **E2B(R3)**: G.k.8 Action(s) Taken with Drug
* **PMDA MHLW Paper Form**: Detail Form 2-4, G.k.8 Action(s) Taken with Drug
* **CIOMS I (Chinese)**: Section I, 7 + 13 Describe Reaction(s)
* **NMPA E2B(R3)**: G.k.9.i.CN.2 Is stopped or reduced, does the reaction disappear or decrease? 停药或减量后，反应是否消失或减轻

This _Controlled Vocabulary_ also impacts how Vault populates dechallenge values on CIOMS I, FDA 3500A, and NMPA E2B(R3) reports. If you configure custom _Action Taken_ records, ensure that you map E2B codes properly.

### Case Assessment Method {#case-assessment-method}

This _Controlled Vocabulary_ type determines the available _Method of Assessment_ field values on _Case Assessments_ and maps to the following reports and data elements: 

* **ICH E2B(R3)**: G.k.9.i.2.r.2 Method of Assessment
* **EMA E2B(R3)**: G.k.9.i.2.r.2.EU.1 EU Method of Assessment
* **MFDS E2B(R3)**: G.k.9.i.2.r.2.KR.1 KR Method of Assessment
* **PMDA MHLW Paper Form**: Detail Form 2-4, G.k.9.i.2.r.2 Method of Assessment

The _Method of Assessment_ field is unique to the Case Assessment Method Controlled Vocabulary. This field does not control any functionality, but shows the mapping to the deprecated _Case Assessment Method_ field and is for reference purposes only. 
You cannot edit this field for records with an API Name ending in <code>__v</code>.

### Case Assessment Result {#case-assessment-result}

This _Controlled Vocabulary_ type determines the available _Assessment Result_ field values on _Case Assessments_ and maps to the following reports and data elements:

<table>
    <thead>
        <tr>
            <th>Report</th>
            <th>Data Element</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><ul>
            <li>ICH E2B(R3)</li>
            <li>FDA VAERS E2B(R3)</li>
            <li>PMDA E2B(R3)</li>
            </ul></td>
            <td>G.k.9.i.2.r.3 Result of Assessment</td>
        </tr>
        <tr>
            <td><ul>
            <li>EMA E2B(R3)</li>
            </ul></td>
            <td>G.k.9.i.2.r.3.EU.1 Result of Assessment</td>
        </tr>
        <tr>
            <td><ul>
            <li>MFDS E2B(R3)</li>
            </ul></td>
            <td>G.k.9.i.2.r.3.KR.2 KRCT Result of Assessment</td>
        </tr>
        <tr>
            <td><ul>
            <li>ICH E2B(R2)</li>
            <li>FDA E2B(R2)</li>
            <li>Health Canada E2B(R2)</li>
            </ul></td>
            <td>B.4.k.18.4 Result of Assessment</td>
        </tr>
        <tr>
            <td><ul>
            <li>PMDA MHLW Paper Form</li>
            </ul></td>
            <td>Detail Form 2-4, G.k.9.i.2.r.3 Result of Assessment</td>
        </tr>
    </tbody>
</table>

Vault uses this _Controlled Vocabulary_ type to determine whether case causality was established to be related to the suspect product, which impacts the following features:

* Classifying adverse events in PADER line listings
* Auto-calculating relatedness at the _Case_ level

The _Assessment Result_ and _Causality Established_ fields are unique to the _Case Assessment Result_ controlled vocabulary. The following table describes these fields:

<table>
    <thead>
        <tr>
            <th>Field Name</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><a id="causality"></a>Assessment Result</td>
            <td><p>Based on the value in the <em>Assessment Result</em> field of the <em>Case</em>, Vault maps the value in the <em>E2B Code</em> field of the corresponding <em>Case Assessment Result</em> controlled vocabulary.</p> <p>You cannot edit this field for records with an API Name ending in <code>__v</code>.</p></td>
        </tr>
        <tr>
            <td>Causality Established</td>
            <td><p>This field controls whether a <em>Controlled Vocabulary</em> record indicates relatedness (causality) between a suspect product and adverse event. You can select one of the following options:</p><a id="sourcetype"></a>
                <ul>
                    <li><strong>Yes</strong>: Indicates that the adverse event was caused by the suspect product.</li>
                    <li><strong>No</strong>: Indicates that the adverse event was not caused by the suspect product.</li>
                </ul>
            <p>This setting is used for PADER aggregate reporting to classify adverse events in non-15 day reports and line listings. <a href="/en/gr/01281/">Generate PADER Aggregate Reports</a> describes how PADER reports are generated.</p>
            <p>This setting is also used to determine <em>Case</em>-level relatedness and automatically populate the <em>Relatedness</em> field. </p>
            <p>For records with an API Name ending in <code>__v</code>, you can edit this field only when the <em>E2B Default Value</em> field is set to <em>No</em> or is blank.</p>
            </td>
        </tr>
    </tbody>
</table>

<a id="relatedness"></a>

### Case Assessment Source {#case-assessment-source}

This Controlled Vocabulary type determines which options users can select in the **Source Type** field on a Case Assessment. This Controlled Vocabulary maps to:

* **EMA E2B(R3)**: G.k.9.i.2.r.2.EU.1 EU Method of Assessment
* **ICH E2B(R3)**: G.k.9.i.2.r.1 Source of Assessment
* **PMDA MHLW Paper Form**: Detail Form 2-4, G.k.9.i.2.r.1 Source of Assessment

For custom Case Assessment Sources that should be considered a company source, set the E2B Code to `2` (sponsor) or `4` (MAH). All other codes are considered from the source reporter. 

This Controlled Vocabulary type impacts how Vault populates the Case **Relatedness** field. <a href="/en/gr/01160/">Case Relatedness</a> provides more information.
<a id="hcp"></a>

The **Source Type** field is unique to the Case Assessment Source Controlled Vocabulary.<br>
This field does not control any functionality. This field shows the mapping to the deprecated Case Assessment Source field and is for reference purposes only.<br>
You cannot edit this field for records with an API Name ending in <code>__v</code>.

### Combination Product Type {#combination-product-type}

This Controlled Vocabulary type determines which options users can select in the **Combination Type** field for entering registration information while adding a product to the Product Library.

### Completeness {#completeness}

This Controlled Vocabulary type maps to the **Completeness** field for entering data about the case completeness on each reporting Case. This Controlled Vocabulary maps to PMDA E2B(R3) data element J2.7.1

### Device Follow-Up Type {#device-cv}

This Controlled Vocabulary type determines which options users can select in the **Device Follow-Up Type** field for entering information about the follow-up reason for Follow-Up Cases concerning a combination product with a device constituent. This Controlled Vocabulary maps to E2B data elements B.4.k.20.FDA.18.1a–d
<a id="fda-concept-code"></a>

The **FDA Concept Code** field is available for this Controlled Vocabulary type.<br>
<a id="deprecate-cvs"></a>For custom Device Follow-Up Type or Device Usage Type Controlled Vocabularies, enter the FDA concept code for electronic Medical Device Reporting (eMDR).

### Development Phase {#development-phase}

This Controlled Vocabulary type maps to the **Development Phase** field to determine which options users can select in that field for entering study information. This Controlled Vocabulary maps to:

* **PMDA E2B(R3)**: J2.13.r.3 Development Phase
* **PMDA MHLW Paper Form**: Detail Form 2-1, J2.13.r.3 Development Phase

### Device Usage Type {#device-usage-type}

This Controlled Vocabulary type determines the _Device Usage Type_ options available when users enter _Case Product_ information for a _Device_. This Controlled Vocabulary maps to: 

* **FDA E2B(R2)**: B.4.k.20.FDA.15 Device Usage
* **EU MIR**: 3.2e. Usage of device (as intended)

The _FDA Concept Code_ field is available for this Controlled Vocabulary type.<br>
<a id="deprecate-cvs"></a>For custom Device Follow-Up Type or Device Usage Type Controlled Vocabularies, enter the FDA concept code for electronic Medical Device Reporting (eMDR).

### Drug Role {#drug-role}

This _Controlled Vocabulary_ determines the available _Drug Roles_ on _Case Products_ and maps to the following reports and data elements

* **E2B(R3)**: G.k.1 Characterisation of Drug Role
* **CIOMS I (Chinese)**: Section III, 22. Concomitant Drug(s) and Dates of Administration

Vault includes the following standard roles, however you can create additional custom records:

* **Suspect**: Identifies a product suspected to have contributed to the adverse event.
* **Interacting**: Identifies a product suspected to have an interaction with another product.
* **Concomitant**: Identifies a product taken by the patient at the time the reaction was observed.
* **Drug Not Administered**: Identifies a product that was not administered, but must be reported. For example, in a clinical trial setting or due to a product administration error. In Vaults with the <a href="/en/gr/740208/#metrics-other">_Extend Suspect Definition to Include Drug Not Administered_</a> general setting enabled, Vault evaluates this role as _Suspect_.
* **Similar Device**: Identifies a US-marketed product (such as a vaccine) that contains the same or similar device as the suspect product for which a malfunction was reported. This option is used in FDA VAERS submissions for scenario 10 (a malfunction combination product with a similar device).
* **Treatment**: Identifies products used to treat the adverse event. This drug role is for tracking purposes only and does not appear on generated regulatory reports.


### Ethnicity {#ethnicity}

This Controlled Vocabulary type determines which options users can select in the **Ethnicity** field for entering patient information on the Case. 

This Controlled Vocabulary maps to FDA VAERS E2B(R3) data element **FDA.D.12 Patient Ethnicity**.

### Facility Type {#facility-type}

This Controlled Vocabulary type determines which options users can select in the **Facility Type** field on Facility-type Case Contact records.

This Controlled Vocabulary maps to FDA VAERS E2B(R3) data element **FDA.G.k.4.r.14.8 Vaccination Facility Type**.

### First Sender {#first-sender}

This Controlled Vocabulary type determines which options users can select in the **First Sender** field on the Transmission object. This Controlled Vocabulary maps to E2B data element A.1.10.2

### Gender {#gender-identity}

This Controlled Vocabulary type determines which options users can select in the _Gender_ field for entering patient information on the _Case_. This Controlled Vocabulary maps to FDA MedWatch 3500A (August 2024 Version) box A3b. Gender.

### Highlighted Term {#highlighted-term}

This Controlled Vocabulary type determines which options users can select in the **Highlighted Term** field when entering information on a Case Adverse Event. This Controlled Vocabulary maps to E2B data element B.2.i.3

### Literature Classification {#literature-classification}

This Controlled Vocabulary type maps to the **Literature Classification** field on the document for classifying the literature document. This Controlled Vocabulary maps to PMDA E2B(R3) data element J2.17.r

### Localized Case Assessment Result {#localized-case-assessment-result}

This _Controlled Vocabulary_ type determines the available values in the _Localized Assessment Result_ field on _Localized Case Assessment Results_ and maps to:

* MFDS E2B(R3) data element G.k.9.i.2.r.3.KR.1 WHO-UMC Result of Assessment
* NMPA E2B(R3) data element G.k.9.i.2.r.CN.2 Assessment Results 评估结果

### Localized Case Assessment Source {#localized-case-assessment-source}

This _Controlled Vocabulary_ type determines the available values in the _Localized Assessment Source_ field on _Localized Case Assessment Results_ and maps to NMPA E2B(R3) data element G.k.9.i.2.r.CN.1 Initial Report/Marketing Licensee Evaluation Source 初始报告人/上市许可持有人评估来源.

### Military Status Type {#military-status-type}

This Controlled Vocabulary type maps to the **Military Status** field for entering data about the patient on a Case.

This Controlled Vocabulary maps to FDA VAERS E2B (R3) data element **FDA.D.14 Patient Military Status**.

### MFDS Health Professional Type {#mfds-health-professional-type}

This Controlled Vocabulary type determines which options users can select in the **MFDS Health Professional Type** field on a Localized Organization. This Controlled Vocabulary maps to MFDS E2B(R3) data element C.3.1.KR.1.

### MFDS Other Health Professional Type {#mfds-other-health-professional-type}

This Controlled Vocabulary type determines which options users can select in the MFDS Other Health Professional Type field on a Localized Case Contact. This Controlled Vocabulary maps to MFDS E2B(R3) data element C.2.r.4.KR.1.

### MFDS Other Study Type {#mfds-other-study-type}

This Controlled Vocabulary type determines which options users can select in the MFDS Other Study Type field on a Localized Study and/or Localized Case for study cases. This Controlled Vocabulary maps to MFDS E2B(R3) data element C.5.4.KR.1.

### NMPA Patient Nationality Code

This _Controlled Vocabulary_ determines the available _NMPA Patient Nationality Code_ options on _Localized Case Contacts_ and maps to NMPA E2B(R3) data element D.CN.1.

### NMPA Report Source

This _Controlled Vocabulary_ determines the available _NMPA Report Source_ options on <em>Reporter</em>-type _Localized Case Contacts_ and maps to NMPA E2B(R3) data element C.1.CN.1.

### NMPA Report Classification

This Controlled Vocabulary type determines which options users can select in the NMPA Report Classification field on a Localized Case. This Controlled Vocabulary maps to NMPA E2B(R3) data element C.1.CN2.

### NMPA Race

This Controlled Vocabulary type determines which options users can select in the NMPA Patient Race field on a Localized Case Contact. This Controlled Vocabulary maps to NMPA E2B(R3) data element D.CN.2.

### OTC Drug Channel {#otc-drug-channel}

This Controlled Vocabulary type maps to the **OTC Drug Channel** field for entering data about from where the reported OTC drug obtained. This Controlled Vocabulary maps to:

* **PMDA E2B(R3)**: J2.6.k Obtaining channels for OTC drugs
* **PMDA MHLW Paper Form**: Detail Form 2-1, J2.6.k Obtaining channels for OTC drugs

### OTC Drug Classification {#otc-drug-classification}

This Controlled Vocabulary type maps to the **OTC Drug Classification** field for entering data about the classification of OTC drugs. This Controlled Vocabulary maps to:

* **PMDA E2B(R3)**: J2.5.k Classification of OTC drugs
* **PMDA MHLW Paper Form**: Detail Form 2-1, J2.5.k Classification of OTC drugs

### Outcome {#outcome}

This _Controlled Vocabulary_ determines the available _Outcome_ values on _Case Adverse Events_ and maps to the following reports and data elements:

* **E2B(R2)**: B.2.i.8 Outcome of reaction/event at the time of last observation
* **PMDA MHLW Paper Form**: Detail Form 2-2, E.i.7 Outcome of Reaction / Event at the Time of Last Observation
* **CIOMS I (Chinese)**: Section I, 7 + 13 Describe Reaction(s)
* **NMPA E2B(R3)**: G.k.9.i.CN.2 Is stopped or reduced, does the reaction disappear or decrease? 停药或减量后，反应是否消失或减轻

### PMDA Reporting Category {#pmda-reporting-category}

This _Controlled Vocabulary_ type determines the available _PMDA Reporting Category_ options on _Local Reporting Details_ records and maps to:

* **PMDA E2B(R3)**: J2.1a PMDA Reporting Category
* <a href="/en/gr/1005170/">**PMDA Medical Device & Regenerative Medicine Forms**</a>: Field M.1.1 管理番号_報告分類 and M.2.1 報告の別 (Reporting category) on all forms

Vault also generates standard <a href="/en/gr/827489/">PMDA MHLW Paper Forms</a> based on the _PMDA Reporting Category_.

### Qualification {#qualification}

This Controlled Vocabulary type determines which options users can select in the **Qualification** field for entering the Case Contact, and which options indicate a qualified health care professional (HCP). This Controlled Vocabulary maps to:

* **E2B(R3)**: C.2.r.4 Qualification
* **E2B(R2)**: A.2.1.4 Qualification
* **PMDA MHLW Paper Form**: Detail Form 2-1, C.2.r.4 Qualification

The **Qualified HCP** and **Reason Omitted** fields are specific to the Qualification Controlled Vocabulary. The following table describes these fields:

<table>
    <thead>
        <tr>
            <th>Field Name</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><a id="omitted"></a>Qualified HCP</td>
            <td><p>This field determines whether an occupation qualifies as a health care professional for the source reporter.</p> <p>This field determines how the <strong>HCP Confirmed</strong> field is populated on the Case Adverse Event and how Case Assessment Results are generated. <a href="/en/gr/01172/#case-assessments">Enter a Case Assessment</a> provides more details.</p></td>
        </tr>
        <tr>
            <td>Reason Omitted</td>
            <td>Set this field to <strong>Yes</strong> for a Controlled Vocabulary that should allow users to enter data in the Reasons Omitted field.</td>
        </tr>
    </tbody>
</table>

### Reaction Recurrence {#reaction-recurrence}

This Controlled Vocabulary type determines which options users can select in the **Reaction Recurrence** field when entering a Case Assessment. This Controlled Vocabulary maps to E2B data element B.4.k.17.1

### Registration Type {#registration-type}

This Controlled Vocabulary type determines which options users can select in the **Registration Type** field for entering registration information while adding a product to the Product Library. 

The **Registration Category** field is specific to the Registration Type Controlled Vocabulary.<br>
You can categorize a Registration Type as either Investigational or Marketing. The Registration Category is considered during <a href="/en/gr/01247/">cross reporting evaluation</a>.

This Controlled Vocabulary maps to Detail Form 2-1, data element J2.4.k License Category of New Drug of the PMDA MHLW Paper Form.

### Remedial Action {#remedial-action}

This Controlled Vocabulary type determines which options users can select in the **Remedial Action** field for entering information about device-type Cases. This Controlled Vocabulary maps to E2B data elements B.4.k.20.FDA.14.1a–i

### Report Type {#report-type}

This Controlled Vocabulary type determines which options users can select in the **Report Type** field for entering how an adverse event was reported on an Inbox Item or Case. This Controlled Vocabulary maps to E2B data element A.1.4

<a id="solicited"></a>
Vault Safety has logic to determine whether reports are considered solicited or non-solicited. By default, Cases with a report type of Study are considered solicited. Other report types are considered non-solicited or spontaneous. 

The **Solicited Report** and **Literature** fields are specific to the Report Type Controlled Vocabulary. The following table describes these fields:

<table>
    <thead>
        <tr>
            <th>Field Name</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Solicited Report</td>
            <td><p>When set to <strong>Yes</strong>, indicates a solicited report type.</p>
                <p>PADER aggregate reports no longer use this field to determine which report types are solicited. See <a href="/en/gr/01281/">PADER Table Data Mapping</a> for details on how Vault determines solicited Cases for PADER.</p></td>
        </tr>
        <tr>
            <td>Literature</td>
            <td><p>When set to <strong>Yes</strong>, indicates a report type from a literature source.</p></td>
        </tr>
    </tbody>
</table>

### Sender Type {#sender-type}

This Controlled Vocabulary type determines which options users can select in the **Sender Type** field for adding an Organization. This Controlled Vocabulary maps to E2B data element A.3.1.1

### Sex {#gender}

This Controlled Vocabulary type determines which options users can select in the _Sex_ field for entering patient information on the _Case_. This Controlled Vocabulary maps to:

* E2B data element B.1.5
* FDA MedWatch 3500A (August 2024 Version) box A3a. Sex
* FDA MedWatch 3500A (October 2015 Version) box A3. Sex

### Study Type {#study-type}

This _Controlled Vocabulary_ type determines the available _Study Type_ options when entering study information on a _Case_, as well as how study _Cases_ are classified in aggregate reports. This _Controlled Vocabulary_ maps to:

* **E2B(R3)**: C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed
* **E2B(R2)**: A.2.3.3 Study Type Where Reaction(s) / Event(s) Were Observed
* **PMDA MHLW Paper Form**: Detail Form 2-1, C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed

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      <p><strong>Note</strong>: Vault maps E2B codes to E2B formats based on your <a href="/en/gr/01288/#study-type">configuration of <em>Study Type</em></a> values.</p>
    </div>
  </div>
</div>



### Test Result {#test-result}

This Controlled Vocabulary type determines which options users can select in the **Result (Code)** field for entering Case Test Results. This Controlled Vocabulary maps to E2B data element F.r.3.1

### Transmission Reason {#transmission-reason}

This Controlled Vocabulary type determines which options users can select in the **Reason** field on the Transmission object. This Controlled Vocabulary maps to:

* **E2B(R3)**: C.1.11.1 Report Nullification/Amendment
* **E2B(R2)**: A.1.13 Report Nullification / Amendment
* **PMDA MHLW Paper Form**: Cover Form 1, C.1.11.1 Report Nullification / Amendment

## Deactivate a Controlled Vocabulary

To deactivate a Controlled Vocabulary, an administrator must enable the user action to modify the object state. <a href="/en/gr/01435/">Enable Controlled Vocabulary User Actions</a> provides more information.

Admins can deactivate Controlled Vocabularies using the user action. Access the user action on the Controlled Vocabulary from the **All Actions** menu.


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    <div class="alert-text">
      <p><strong>Note</strong>: If you try to import a Case containing terms that match inactive Controlled Vocabularies in Vault Safety, the import will fail. For this reason, we recommend that you deprecate Controlled Vocabularies instead of deactivating them.</p>
    </div>
  </div>
</div>



[1]: #deprecated-cv
[2]: #types
[3]: #deprecated-cv
[4]: #deactivate-cv