All Actions Menu

The All Actions menu allows you to perform various actions on some kind of element in the vault - a document, report, or object, for example.

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An Activity is a system-managed, read-only object. Activity records provide a unified view of workflow and user task statuses. You can use Activity records to create reports on task completion in your vault.

Access Control

Access control refers to various ways that Admins can grant or remove access to object records or documents.

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Admin Area

The Admin area is where you’ll find configuration options and administrator-level actions in Vault.

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Administrators or Admins are users who have permissions (through their security profile) to the Admin area in Vault. The level of access depends on the permission sets.

Adverse Event (AE)

Any expected or unexpected medical occurrence in a patient after a medicinal product has been administered either during clinical trials or after the drug is marketed.

Adverse Event Reaction

An Adverse Event Reaction is an undesired reaction associated with the use of a medicinal product. The causal relationship between the reaction and the products has been established.


AER stands for adverse event report. AER is a type of the Case object in Vault Safety that captures basic case information. AERs precede Case creation and are used for early triage. You can create a Case in Vault Safety by promoting an AER, provided that the AER contains key information.

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Adverse Events of Special Interest (AESI)

These are serious or non-serious adverse events that are scientific and of medical concern. They are specific to the sponsor's product, and ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.

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Aggregate Report

Aggregate reports compile safety data for a drug over a period of time, usually months or years.

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Applying automation and artificial intelligence to reduce manual effort and overhead.


Alias refers to alternate labels that users set up in your vault for columns in a report, filters or filter prompts in a report, document relationships in a relationship report, user profiles, and Products or Substances.


Annotations are comments and markings made within the document viewer to provide feedback on the document.

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Application Programming Interface – Vault’s REST-based API that allows for programmatic access to most Vault functions and configurations.

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Application License Type

In multi-application vaults, a user’s Application License Type lets the system track available licenses at the application level, but does not control the user’s access to features like License Type.

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Application Role

The Application Role object maps lifecycle roles to a higher “application-level” role, adding an extra level of organization for User Role Setup objects. The Application Role object is active and available in all vaults.

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Approved Case

An approved Case is one that has reached a workflow step where it is stable and contains the necessary information to be able to make regulatory reports.

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Audit Log

Audit Logs display a history of actions within your vault. Audit Logs include Document Audit History, Domain Audit History, Login Audit History, and System Audit History.

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Audit Trail

Audit trails are a list of all actions performed in the system. Vault provides audit trails at the document, system, login, and domain levels.

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Base Document

Base Document is the highest level in the document type hierarchy — the parent of all document types. A document or binder cannot be a “Base Document” because this level exists only for configuration purposes.

Basic Document Template

Basic document templates use an Admin-uploaded document as the template’s source file. These templates are created and managed in Admin > Document & Binder Templates.


A standard object used to support the Batch Approval feature, which lets users move multiple documents into a new lifecycle state as a “batch.”

Benefit-Risk Assessment

The benefit-risk assessment compares the benefits associated with a drug against the risks to patients.


Binders allow you to organize and group documents in a flexible structure. Binders are comprised of sections, which can nest to build a hierarchical structure, and links to documents in Vault.

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Binder Content

Binder content refers to the documents within a binder, which may include other binders. These are also called component documents and component binders.

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Binder Template

Binder templates contain the structure (binder sections) of a binder and “planned” documents serving as markers for documents that should be in the binder.

Blinded Case

Cases under a double-blinded study are blinded by default, masking the suspect product.

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Blind Protection

Blind protection activates after unblinding and masks sensitive information that could compromise the integrity of a study from unauthorized users.

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Business Admin

Business Admin is a section within the Admin area. From here, users can access ongoing administration options, such as product or study object records, document templates, and picklist options.



Cart lets you quickly create an ad hoc group of documents from multiple filter sets and Library views. From that group, you can download source files or perform bulk actions. Learn more in Using Cart.

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The Vault Safety Case object captures information about one or more adverse events related to a study or marketed product, which can then be used to generate regulatory reports such as an E2B-formatted ICSR or aggregate reports.

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Case Version

Cases are versioned at major submission milestones. Old Case versions are superseded but accessible.

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Causality refers to the relationship of a given adverse event to a specific drug.

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A standard of ICH that is used for worldwide submissions of Clinical Trial and Post Marketed Adverse Events.

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Classification is the lowest level of the document type structure (Type > Subtype > Classification).

Clinical Trial

Research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention.

Clinical Trial Case

A Case is categorized as a clinical trial case when the Case Report Type is "Study" and the Study Type is "Clinical Trial" or unspecified (blank).

 report_type__v.controlled_vocabulary__v.e2b_code__v = 2
study_product_reason__v.controlled_vocabulary__v.e2b_code__v = {1 OR null}

Closed Case

A Case which has been fully reported as an Individual Case Safety Report (ICSR)

Combination Product

A product containing multiple constituents and any combination of drug, device, and/or biologic components. You can create combination products by applying the Combination Product object type to a Product.

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Company Product

A Product configured in a Vault's Business Admin Product Library.

Concomitant Medications (Con-Meds)

Prescription medications, over-the-counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation.

Configuration Mode

Configuration Mode allows an Admin to lock non-Admin users out of a vault in order to complete certain configurations.

Controlled Document Template

Controlled document templates allow users to create templates using regular Vault documents as the template source file. These templates use a Steady state Vault document as the template’s source file.

Controlled Vocabulary Codelist

Controlled vocabulary codelists align with the ICH Controlled Vocabularies for Drug Safety and E2B data transmission.

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Custom Tab

A custom tab is a tab added by an Admin to the navigation bar. This tab can open a list of documents of a certain type, object records for a specific object, or an external webpage.

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Dashboards provide an at-a-glance understanding of key metrics. Each dashboard contains one or more dashboard components and each component displays metrics from a report.

Designated Medical Events (DME)

A watchlist tag. Events that are always considered serious when occurring in conjunction with specified products, regardless of the reporter’s or company’s opinion.

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Development Safety Update Report (DSUR)

A Drug Safety Update Report and a type of aggregate report for Cases that occur during a clinical trial. The submission includes statuses of in-progress studies, newly completed studies, summary updates to the study, Investigator’s Brochure, etc. during the calendar year.

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Detail View

Detail View is a Library layout that lists documents in rows. Each row shows a thumbnail of the document and important document fields.

Doc Info

The Doc Info (or DocInfo) page is the main page that displays information about a document, including document fields, security settings, versions, renditions, related documents, and the document content itself within an embedded viewer.


Within Veeva Vault, a document is an object consisting of both content and fields (metadata).

Document Checkout

Document checkout is a method of changing the source file for a document already uploaded to Vault.

Document Lifecycle

A document lifecycle is the sequence of states (Draft, In Review, etc.) that a document goes through during its life. Each lifecycle has associated business logic, including workflows and permissions for specific user roles.

Document Lifecycle State

Lifecycles are a sequence of states (Draft, In Review, etc.) that a document goes through during its life.

Document Linking

Document links allow you to link specific pages or paragraphs between documents in your vault.

Document Owner

Document Owner or “Owner” is a standard user role that applies to all documents and binders.

Document Role

A document role is a way of assigning users a specific set of permissions on a specific document.

Document Template

Document templates allow users to create a document using the template’s source file rather than uploading new content. Templates are associated with a specific document type. There are two types of document templates.

Document Type

Document type refers both to the structure of hierarchical fields (Type > Subtype > Classification) that determines the relevant document fields, rendition types, and other settings for a document, and to the highest level in that hierarchy.

Document Version Number

A document’s version number is in the format x.y where “x” is the major version and “y” is the minor version.

Document Viewer

The document viewer is a portion of the Doc Info page where Vault displays a document’s viewable rendition and users can add or view annotations.

Document-Level Comments

Document-level comments are a mechanism to provide feedback on a document that is not related to a specific portion of the document. Document-level comments are tied to a specific version of a document.


A domain is an instance of Veeva Vault that belongs to a single customer and shares several settings.

Domain Admin

Domain Admin is a user-level setting that, along with the correct permissions, grants users access to edit domain-level settings and to manage users across vaults. Each domain has at least one user with this setting.

Due Date

Date the case is due to be submitted to a regulatory authority.

Dynamic Access Control (DAC)

Dynamic Access Control for documents and objects is a way of making access control more programmatic and less manual.


E2B (R2)

An ICH Standard for electronic data exchange of ICSRs (Release 2).

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E2B (R3)

An ICH Standard for electronic data exchange of ICSRs (Release 3).

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An eSignature (or electronic signature) is a way for users to officially “sign” a document in Vault by re-entering their usernames and passwords.

European Medicines Agency (EMA)

EU Health Authority (with 28 member states) in Europe. Individual countries still have their own country health authorities.

External User

External User is a license type for users outside your company who have slightly limited access; these users have most functionality, but cannot use reports, use dashboards, or provide eSignatures.


FDA Adverse Event Reporting System (FAERS)

A database that contains information on adverse event and medication error reports submitted to FDA.

FDA Center for Biologics Evaluation and Research (CBER)

Regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.

FDA Center for Drug Evaluation and Research (CDER)

As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.

FDA 3500A MedWatch

An FDA form used to submit adverse events manually for clinical and postmarket adverse events.

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Federated ID

Federated ID allows Vault to associate the user with an external user ID for single-sign-on or other system integration purposes.


Fields include both Admin-configurable and standard fields which hold additional details/metadata for each document or object; document fields can apply to all documents or specific document types/subtypes/classifications and can be required/optional.

Follow-Up Questionnaire

A request that is sent to the reporter to obtain additional details on a known adverse reaction / event in order to process the case.

Full User

Full User is a license type for standard users. This license type does not block access to any functionality. Users with this license type may be end users or administrators. This is the only license type that allows access to Admin functionality.


Gateway: AS2

AS2 (Applicability Statement 2) is a specification about how to transport structured business-to-business data securely and reliably over the Internet.

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Gateway: AS2 E2B ACK

Acknowledgement message when an E2B file has been accepted by the trading partner.

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Gateway: AS2 MDN

Message Disposition Notification (MDN). An electronic return receipt which a trading partner can optionally request during an AS2 interchange.

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Gateway: FDA ESG

The FDA AS2 Electronic Submissions Gateway (ESG), used to submit Individual Case Safety Reports (ICSRs) to the FDA electronically.

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Gateway: EU EMA EV

The EMA EudraVigilance AS2 Gateway, used to submit Individual Case Safety Reports (ICSRs) to the EMA electronically.

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A group is simply a named list of users. By defining groups that reflect the teams and business functions in your company and assigning those groups to document roles, you can manage document access more easily.


Home Tab

The Home tab is the area that Vault typically loads when a user logs in, also called “Vault Home.” From here, users access their assigned tasks, notifications, and active workflows. Note that this is called the Tasks tab on some vaults.

Hover Card

When hovering over certain elements (document names, object labels, etc.) for more than a second, Vault displays a summary of the element’s information in a small pop-up “hover card”.


Identity Provider

An Identity Provider (IdP), also known as Identity Assertion Provider, is responsible for issuing identification certificates and the entity responsible for authenticating a user before allowing the user access to Vault via Single Sign-On (SSO).


Identification of Medical Products

Imported Case

An Imported Case is a type of the Case object reserved for previously processed cases migrated from an external system.

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In-Flight Case

An open Case that has not completed case processing (generally in any state before Approved, Closed, or Superseded).





A “license” typically grants one user access to one application. Some vaults may share the total number of licenses through “pooling.” In multi-application vaults, each user-application relationship uses one license.

License Type

License type is a user attribute that Vault uses as the first level of access control for the user. License type trumps any access granted through the user’s security profile or through a document’s sharing settings and security matrix.

Lifecycle State Entry Actions

A lifecycle state’s entry actions are a configurable set of system actions that Vault automatically performs on a document or object record when it enters the lifecycle state.

Lifecycle State Entry Criteria

A lifecycle state’s entry criteria are a configurable set of conditions that a document or object record must meet before moving into the state.

Lifecycle State User Actions

User actions for lifecycle states are configurable actions that allow users can perform on documents or object records.


Locale is a user-level setting related to localization and the user’s language. This setting controls the display of dates and numbers.

Lookup Field

A lookup field is a field that propagates values from a parent or referenced object to a child object, referring object, or document. This allows users to view additional relevant information from a parent or referenced object record.


Matching Sharing Rules

Matching sharing rules are part of Dynamic Access Control (DAC) for objects. They provide access control at the record level. When an object or document uses custom or matching sharing rules, Vault introduces new roles on the records.

MedDRA Dictionary

The Medical Dictionary for Regulatory Activities (MedDRA) is a dictionary of terms that define medical conditions. Use the MedDRA dictionary to code symptoms, disease, indicators, and adverse events.

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Merge Fields

Merge Fields is a standard, shared document field with two functions. By associating the field to a document type, Admins indicate that the document type supports the Merge Fields for MS Word™ feature.


“Metadata” in Vault generally refers to information about a document other than the document’s source file, like document field values.


Non-Vault User

A non-vault user is a person accessing documents through Vault who does not have a user account. These users can only view documents sent using the Send as Link feature.


Object Class

An object class is a classification of an object that can apply to multiple objects at once.

Object Field Default

An object field default is an Admin-defined formula or value for a field that Vault uses to populate the field on object record creation or save.

Object Record

Each vault has a data model consisting of objects, their fields, and their relationships. Object records are pieces of data within this model.

Object Lifecycle

An object lifecycle is the sequence of states (In Approval, Approved, etc.) that an object record may go through during its life. Each state can have associated user actions and entry actions.

Object Lifecycle State

Object lifecycle states (In Approval, Approved, etc.) are statuses that an object record may go through during its life.

Object Reference

Vault objects can have various relationships including parent-child (hierarchical) and reference (non-hierarchical) relationships.


Parental Case

A Parental Case is a type of Case object used for cases involving children where parental information is required (such as Medical History, Drug History, and so on) but the parent themselves have not experienced an adverse event.

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A Periodic Benefit-Risk Evaluation Report. A type of aggregate report used to collect and report on Cases for postmarket products.

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“Permission” can refer to two different types of permissions. The first type of permission is applied through a permission set and security profile.

Permission Set

Permission sets allow organizations to grant application-level access to certain features, particularly system administration functions such as user management or object record creation.


Picklists allow users to select a value for a field from a range of predefined options.


PMOA stands for Primary Mode of Action and identifies which constituent part provides the primary therapeutic action of the combination product. In Vault Safety, Product Constituents are set as PMOA through the PMOA field on the Product Registration.

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Postmarket Case

A Case is defined as postmarket when the Case has either a non-Study Report Type (spontanous case) or a postmarket Study Type (postmarket study case).

Postmarket Study Case

A Case is categorized as a postmarket study case when it has a Study Report Type and a Study Type of "Individual Patient Use" or "Other Study".

 report_type__v.controlled_vocabulary__v.e2b_code__v = 2
study_product_reason__v.controlled_vocabulary__v.e2b_code__v = {2 OR 3}

Pregnancy Case

A Case involving pregnancy exposure to company products. Vault Safety supports collecting information on pregnancy exposure to products and the birth outcome associated with each pregnancy.

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Primary Navigation Bar

The primary navigation bar is the bar that appears near the top of the page in Vault. Both your permissions and your vault’s configuration can modify what appears in this bar, but many users see at least Home, Library, Reports, and Dashboards.

Product Constituent

A single drug, device, or biologic component within a combination product. These are also known as "constituent parts." In Vault Safety, these are managed using the Product Constituent object.

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Product Registration

Product Registration is a Vault object that contains information specific to registration with a health authority authorizing a product to be distributed within a country.

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Read-Only User

Read-Only User is a license type for users with extremely limited access. These users can only view documents (including annotations), download documents, and participate in Read & Understood workflows.

Document references allow you to link specific pages or paragraphs between documents.

When establishing a reference link, you can optionally provide a comment or annotation.


Renditions are files, other than the source file, that are attached to documents. A document can have multiple renditions.

Required Field

A required field is one that the user must fill in before continuing a process, usually document or object record creation. Admins can make document and object fields required by selecting the User must always enter a value setting in the field configuration.

Routes of Administration

Vault Safety supports the E2B (R3) data entry standard for route of administration terms. You can enter the route of administration as text or as a code from the E2B (R2) dictionary.

Reason Omitted Fields

Reason omitted fields allow you to specify reasons why information is omitted from an associated field. The Reasons Omitted codelist aligns with the ICH-E2B(R3) code format for nullFlavors.


Security Matrix

The security matrix is a settings panel within the document lifecycle state configuration screens that shows and allows editing of the document permissions available to each role for the lifecycle state.

Security Policy

Security policies allow you create and manage password policies for users. These settings control password requirements, expiration period, reuse policy, security question policy, and delegated authentication via

Security Profile

Security profiles are how Vault applies permission sets to individual users. Each profile has one or more associated permission sets.

Signature Page

A signature page is an auto-generated page showing electronic signatures for a document. When generated, signature pages are attached to viewable renditions. The signature page template, assigned at the lifecycle level, determines what information displays on a signature page.

Single Sign-On

Single sign-on (SSO) allows users to access all authorized applications without having to log in separately to each application. Vault supports IdP- (identity provider) initiated SSO using Security Assertion Markup Language (SAML) and SP- (service provider) initiated SAML SSO.

Spontaneous Case

A Case is categorized as a spontaneous case when it has a non-Study Report Type.

 report_type__v.controlled_vocabulary__v.e2b_code__v ≠ 2

Standard Field

A standard field is a document property that is “standard” or “system_managed” in a vault; standard properties vary by Vault application.

Study Selector

Study Selector is a tool for filtering documents and objects by a single study.


Subtype is the second level in the document type structure (Type > Subtype > Classification).

System User

The System user, or System, performs various processes for your application. For example, event and entry actions execute as the System user, allowing the action to take place despite the permissions of the user who initiated the action. The System user is not included in license counts.


Tabular View

Tabular View is a Library layout that functions like a spreadsheet; users can resize or rearrange columns, add columns, sort by column values, and export document metadata.


A task or workflow task is a step within a workflow that must be assigned to a user and which the user must complete in order for the workflow to progress. Users can view their own assigned tasks from Home > My Tasks.


Vault includes several different kinds of templates. Document and binder templates allow quick creation of new documents or binders from a configured template.

Tile View

Tile View is a Library layout that organizes documents into columns and rows, where each tile shows a document thumbnail and important document fields.


Tokens are pieces of text with a specific format that Vault replaces with the values the token represents. They use the format ${tokenName}.

Transmission Type: Distribution

A type of outbound Transmission for an ICSR where the target is a Partner, typically based upon a prior PVA.

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Transmission Type: Inbound Transmission

A type of Transmission that contains the details of an inboound ICSR.

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Transmission Type: Submission

A type of outbound Transmission for an ICSR where the target is a regulatory agency.

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Unclassified Document

Unclassified documents have a source file, but no document type. By skipping the steps to classify the document (assign a document type) and populate the document field, you can upload source files and create documents more quickly.


Unblinding content, such as cases, products, and narratives, makes the content accessible by certain users with appropriate permissions. When you unblind content, the system activates blind protection to prevent unauthorized users from seeing unblinded information.

Units of Measurement Codelist

Units of measurement codelists align with E2B (R3) units of measurement for dose, strength, and time intervals, including support for both the unified code of units of measure (UCUM) and the constrained UCUM.

User Task

A user task is an object record with the User Task object class applied. User tasks represent individual units of work. In your vault, you can configure multiple user task objects by using the User Task object class.



Vault is a cloud-based Content Management System (CMS) developed by Veeva Systems.

Vault Customer Organization

The Vault Customer Organization record is a system-provided object record with the API name of vault_customer__v. Set up Vault Customer with your organization's details.

Viewable Rendition

A viewable rendition is a PDF file (generally generated by Vault, but sometimes uploaded) that displays in the Doc Info page’s viewer.


WHODrug Dictionary

THe WHODrug dictionary allows you to code products using the IDMP-compliant WHODrug dictionary.

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A workflow is a series of steps configured in Vault to align with specific business processes. The different types of steps offer a flexible way to organize a wide variety of processes for a document, including assigning tasks to users, sending notifications and changing document status.

Workflow Cancel State

This is the state that a document or object record returns to when users cancel an in-progress workflow. In document lifecycles, Admins set a specific cancel state for each lifecycle state. In object workflows, object records return to the state they were in when the workflow started.

Workflow Content

Workflow content refers to the documents or object records on which a specific workflow is active. In a multi-document workflow, this is all documents in the workflow.

Workflow Start Dialog

The workflow start dialog is the window that users see when starting a workflow. From this dialog, the workflow owner can assign users to roles that will have workflow tasks, create due dates, and make various other choices, depending on the Admin configuration of the workflow’s Start set.

Workflow Step

Workflow steps define all the actions within a workflow, whether they are user actions like providing electronic signatures or system actions like sending notifications.