Configure Controlled Vocabularies

Controlled Vocabularies contain standard ICH-based terminologies used to describe or code information in a Vault Safety Case.

About Controlled Vocabularies

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 Safety comes with standard and preconfigured Controlled Vocabularies that have varying levels of configurability.

Controlled Vocabularies that have 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 system-managed Controlled Vocabularies, you can only edit 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.

Note: You can tell the difference between standard and custom Controlled Vocabularies by looking at the API Name. Standard Controlled Vocabularies have API Names ending with __v.

Configure Controlled Vocabularies

Go to Business Admin > Objects > Controlled Vocabularies.
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.
Complete the Create Controlled Vocabulary window.
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 below.

Field Name	Description
Type	The Controlled Vocabulary object type. The default Controlled Vocabulary types are described below.
Name	The label for the Controlled Vocabulary record. You can edit this field for standard system-provided Controlled Vocabularies.
E2B Default Value	Set this field to Yes for a Controlled Vocabulary with an associated E2B default code that Vault Safety should map to during an E2B import. E2B Case Import Data Mapping describes how Vault Safety imports E2B data to a Case. You cannot edit this field for records with an API Name ending in `__v`. You cannot set this field to Yes for custom records.
E2B Code	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. E2B Generation Data Mapping describes how Vault Safety exports Case data to an E2B file. For records with an API Name ending in `__v`, you can only edit this field when the E2B Default Value field is set to No or is blank. Note: 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.
API Name	Vault name for the record. You can tell whether a record is standard or custom from the API name. If the name ends with `__c`, it is a custom record. If the name ends with `__v`, it is a standard record. You cannot edit this field for records with an API Name ending in `__v`. You cannot add an API Name ending in `__v` for a custom record.
Status	The Status field determines whether a Controlled Vocabulary is active, deprecated, or inactive. Inactive records are not available for use. Deprecating records prevents future use of the term, while still allowing users to look back at the historic usage of the term. You cannot modify this field in the edit view. You can only edit the Status through a user action on the Controlled Vocabulary. For records with an API Name ending in `__v`, you can only edit this field when the E2B Default Value field is set to No or is blank.

Deprecated Controlled Vocabularies

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.

Note: 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.

Deprecate a Controlled Vocabulary

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

Go to Business Admin > Objects > Controlled Vocabularies.
Hover over the Controlled Vocabulary record to which you want to deprecate.
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:

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

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

Anatomical Site

This Controlled Vocabulary type determines what options are available 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

This Controlled Vocabulary type determines which options are available in the Age Group field for entering patient information on a Case. This Controlled Vocabulary maps to E2B data element D.2.3.

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

This Controlled Vocabulary type determines which options are available in the Action Taken field. This Controlled Vocabulary maps to E2B data element G.k.8.

This Controlled Vocabulary also impacts how Vault populates the dechallenge fields on the CIOMS I and FDA 3500A forms. If you configure custom Action Taken records, ensure the E2B code is mapped properly. For more information, see how Vault populates the dechallenge fields on the CIOMS I and FDA 3500A forms.

Case Assessment Method

This Controlled Vocabulary type determines which options appear in the Method of Assessment field on Case Assessments. This Controlled Vocabulary maps to the following 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
- G.k.9.i.2.r.3.KR.1 WHO-UMC Result of Assessment
- G.k.9.i.2.r.3.KR.2 KRCT Result 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 __v.

Case Assessment Result

This Controlled Vocabulary type determines which options appear for selection in the Assessment Result field on a Case Assessment. This Controlled Vocabulary maps to the following E2B reports and data elements:

E2B Report	Data Element
ICH E2B(R3) FDA VAERS E2B(R3) PMDA E2B(R3)	G.k.9.i.2.r.3 Result of Assessment
EMA E2B(R3)	G.k.9.i.2.r.3.EU.1 Result of Assessment
ICH E2B(R2) FDA E2B(R2) Health Canada E2B(R2)	B.4.k.18.4 Result of Assessment

Vault uses this Controlled Vocabulary type to determine whether Case Causality was established to be related to the Suspect Product, which impacts the following Vault Safety features:

Classifying adverse events in PADER line listings
Auto-calculating Case-level relatedness

The Assessment Result and Causality Established fields are unique to the Case Assessment Result Controlled Vocabulary. The following table describes these fields:

Field Name Description

Field Name	Description
Assessment Result	Based on the value in the Assessment Result field of the Case, Vault maps the value in the E2B Code field of the corresponding Case Assessment Result Controlled Vocabulary. You cannot edit this field for records with an API Name ending in `__v`.
Causality Established	This field controls whether a Controlled Vocabulary record indicates relatedness (causality) between a suspect product and adverse event. You can select one of the following options: Yes: When this kind of assessment result is used, it will indicate that the adverse event was caused by the suspect product. No: When this kind of assessment result is used, it will indicate the adverse event was not caused by the suspect product. This setting is used for PADER aggregate reporting to classify adverse events in non-15 day reports and line listings. Generate PADER Aggregate Reports describes how PADER reports are generated. This setting is also used to determine Case-level relatedness and automatically populate the Relatedness field. For records with an API Name ending in `__v`, you can only edit this field when the E2B Default Value field is set to No or is blank.

Assessment Result

Based on the value in the Assessment Result field of the Case, Vault maps the value in the E2B Code field of the corresponding Case Assessment Result Controlled Vocabulary.

You cannot edit this field for records with an API Name ending in __v.

Causality Established

This field controls whether a Controlled Vocabulary record indicates relatedness (causality) between a suspect product and adverse event. You can select one of the following options:

Yes: When this kind of assessment result is used, it will indicate that the adverse event was caused by the suspect product.
No: When this kind of assessment result is used, it will indicate the adverse event was not caused by the suspect product.

This setting is used for PADER aggregate reporting to classify adverse events in non-15 day reports and line listings. Generate PADER Aggregate Reports describes how PADER reports are generated.

This setting is also used to determine Case-level relatedness and automatically populate the Relatedness field.

For records with an API Name ending in __v, you can only edit this field when the E2B Default Value field is set to No or is blank.

Case Assessment Source

This Controlled Vocabulary type determines which options appear for selection in the Source Type field on a Case Assessment. This Controlled Vocabulary maps to EMA E2B data element G.k.9.i.2.r.2.EU.1 and ICH E2B data element G.k.9.i.2.r.1

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. Case Relatedness provides more information.

The Source Type field is unique to the Case Assessment Source Controlled Vocabulary.
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.
You cannot edit this field for records with an API Name ending in __v.

Combination Product Type

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

Device Follow-Up Type

This Controlled Vocabulary type determines which options are available 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

The FDA Concept Code field is available for this Controlled Vocabulary type.
For custom Device Follow-Up Type or Device Usage Type Controlled Vocabularies, enter the FDA concept code for electronic Medical Device Reporting (eMDR).

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

Development Phase

This Controlled Vocabulary type maps to the Development Phase field to determine which options are available in that field for entering study information. This Controlled Vocabulary maps to PMDA E2B (R3) data element J2.13.r.3

Device Usage Type

This Controlled Vocabulary type determines which options are available in the Device Usage Type field for entering information on a device-type Case Product. This Controlled Vocabulary maps to E2B data element B.4.k.20.FDA.15

Drug Role

This Controlled Vocabulary type determines which options are available in the Drug Role field for entering product information on the Case. This Controlled Vocabulary maps to E2B data element G.k.1

Ethnicity

This Controlled Vocabulary type determines which options are available 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

This Controlled Vocabulary type determines which options are available 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

This Controlled Vocabulary type determines which options are available in the First Sender field on the Transmission object. This Controlled Vocabulary maps to E2B data element A.1.10.2

Gender

This Controlled Vocabulary type determines which options are available in the Gender field for entering patient information on the Case. This Controlled Vocabulary maps to FDA MedWatch 3500A box A3b. Gender.

Highlighted Term

This Controlled Vocabulary type determines which options are available 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

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

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

This Controlled Vocabulary type determines which options appear for selection 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

This Controlled Vocabulary type determines which options appear for selection 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

This Controlled Vocabulary type determines which options appear for selection 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 Report Source

This Controlled Vocabulary type determines which options appear for selection in the NMPA Report Source field on a Localized Case Contact for a reporter. This Controlled Vocabulary maps to NMPA E2B (R3) data element C.1.CN.1.

NMPA Report Classification

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

Outcome

This Controlled Vocabulary type determines which options are available in the Outcome field when entering information on a Case Adverse Event. This Controlled Vocabulary maps to E2B data element B.2.i.8

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) data element J2.6.k

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) data element J2.5.k

PMDA Reporting Category

This Controlled Vocabulary type maps to the PMDA Reporting Category field for entering data about the reporting category for PMDA. This Controlled Vocabulary maps to PMDA E2B (R3) data element J2.1a

Qualification

This Controlled Vocabulary type determines which options are available 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 data element A.2.1.4

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

Field Name	Description
Qualified HCP	This field determines whether an occupation qualifies as a health care professional for the source reporter. This field determines how the HCP Confirmed field is populated on the Case Adverse Event and how Case Assessment Results are generated. Enter a Case Assessment provides more details.
Reason Omitted	Set this field to Yes for a Controlled Vocabulary that should allow users to enter data in the Reasons Omitted field.

Field Name

Description

Qualified HCP

This field determines whether an occupation qualifies as a health care professional for the source reporter.

This field determines how the HCP Confirmed field is populated on the Case Adverse Event and how Case Assessment Results are generated. Enter a Case Assessment provides more details.

Reason Omitted

Set this field to Yes for a Controlled Vocabulary that should allow users to enter data in the Reasons Omitted field.

Reaction Recurrence

This Controlled Vocabulary type determines which options are available 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

This Controlled Vocabulary type determines which options are available 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.
You can categorize a Registration Type as either Investigational or Marketing. The Registration Category is considered during cross reporting evaluation.

Remedial Action

This Controlled Vocabulary type determines which options are available 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

This Controlled Vocabulary type determines which options are available 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

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:

Field Name	Description
Solicited Report	When set to Yes, indicates a solicited report type. PADER aggregate reports no longer use this field to determine which report types are solicited. See PADER Table Data Mapping for details on how Vault determines solicited Cases for PADER.
Literature	When set to Yes, indicates a report type from a literature source.

Field Name

Description

Solicited Report

When set to Yes, indicates a solicited report type.

PADER aggregate reports no longer use this field to determine which report types are solicited. See PADER Table Data Mapping for details on how Vault determines solicited Cases for PADER.

Literature

When set to Yes, indicates a report type from a literature source.

Sender Type

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

Sex

This Controlled Vocabulary type determines which options are available 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 box A3a. Sex

Study Type

This Controlled Vocabulary type determines which options are available in the Study Type (product_usage_reason__v) field for entering study information on a Case.

The Study Type Controlled Vocabulary also determines how Study Cases are classified in aggregate reports.

This Controlled Vocabulary maps to E2B data element A.2.3.3/C.5.4

Test Result

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

Transmission Reason

This Controlled Vocabulary type determines which options are available in the Reason field on the Transmission object. This Controlled Vocabulary maps to E2B(R3) data element C.1.11.1 and the E2B(R2) data element A.1.13.

Deactivate a Controlled Vocabulary

To deactivate a Controlled Vocabulary, an administrator must enable the user action to modify the object state. Enable Controlled Vocabulary User Actions 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.

Note: 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.