# Glossary

In addition to the Safety-specific terms listed on this page, see <a href="/en/lr/22904/">Glossary of Vault Terms</a> for information on terms relevant to Vault overall.

## A

### 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.

### 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.

**Related Articles**:

* <a href="/en/lr/01192/">Configure Adverse Event Watchlists</a>
* <a href="/en/lr/01158/">How Case Watchlist Tags and DMEs are Assigned</a>

### Aggregate Report

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

**Related Articles**:

* <a href="/en/lr/01129/">Aggregate Reports Overview</a>
* <a href="/en/lr/01179/">Configure Aggregate Reporting Families</a>
* <a href="/en/lr/01178/">Configure Aggregate Report Templates</a>

### AI/Automation

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

### 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.

**Related Articles**:

* <a href="/en/lr/01150/">Approve a Case</a>
* <a href="/en/lr/01174/">Revise an Approved Case</a>
* <a href="/en/lr/01171/#case-states">Case Processing Overview: Case States</a>

### <a id="axmp"></a>AxMPs

An Auxiliary Medicinal Product (AxMP) is a medicinal product that is required for use in a Clinical Trial but is not the trial's Investigational Medicinal Product. For countries that use AxMPs (currently Canada, Singapore, and Switzerland), an ICSR must be submitted for any Adverse Event related to an AxMP. An AxMP may be _Authorized_ (it has been approved and is currently marketed), or _Not Authorized_ (it has not been approved, but it is required for the purposes of the Clinical Trial).

**Related Articles**:
* <a href="/en/lr/01250/#axmps-as-reportable-products">Reporting Rule Parameter Reference: Specify AxMPs as Reportable Products</a>


## B

### Benefit-Risk Assessment

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

### Blinded Case

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

**Related Articles**:

* <a href="/en/lr/01216/">Manage Studies</a>
* <a href="/en/lr/01176/">Manage Case Blinding</a>
* <a href="/en/lr/01181/">Bulk Unblind a Study</a>

### Blind Protection

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

**Related Articles**:

* <a href="/en/lr/01216/">Manage Studies</a>
* <a href="/en/lr/01176/">Manage Case Blinding</a>


## C

### Case

The **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.

**Related Articles**:

* <a href="/en/lr/01287/">Case Field Reference</a>
* <a href="/en/lr/01171/">Case Processing Overview</a>
* <a href="/en/lr/01147/">About the Case Page</a>

### Case Access Group

Individuals are assigned to Access Groups based on Case details. This controls the Inbox Items and Cases they can access and whether they can view or edit protected information.

**Related Articles**:

* <a href="/en/lr/01287/">Case Field Reference</a>
* <a href="/en/lr/01290/">Prepare a Localized Case</a>
* <a href="/en/lr/01285/">Inbox Item Field Reference</a>

### Case Collection

The **Case Collection** object is a collection of Case Numbers created for non-submission reporting purposes, such as sharing safety reports with partners or relevant health authorities. Case Collections are used to generate binders of CIOMS I (masked or unmasked) or ICH E2B(R3) reports.

**Related Articles**:

* <a href="/en/lr/680212/">Manage Case and Safety Report Collections</a>

### <a id="case-number"></a>Case Number

The **Case Number** object provides a high-level view of a Case, including all Case Versions, Inbox Items, and open and complete tasks.

**Related Articles**:

* <a href="/en/lr/01199/">See Action Items Across Case Versions</a>
* <a href="/en/lr/680212/">Manage Case and Safety Report Collections</a>

### Case Version

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

**Related Articles**:

* <a href="/en/lr/01148/#case-versions">Add a Follow-Up Case: About Case Versions</a>

### Causality

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

**Related Articles**:

* <a href="/en/lr/01160/">How Case Relatedness is Calculated</a>

### Child Information

_Child Information_ is a type of _Case_ object Vault creates when a user opens a pregnancy _Case_. _Child Information_ records track birth outcomes and test results when there is no adverse event in the child.

**Related Articles**:

* <a href="/en/lr/01149/">Process Pregnancy Cases, Child Information & Parent Information</a>

### CIOMS I

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

**Related Articles**:

* <a href="/en/lr/01224/">Generate a Regulatory Report</a>
* <a href="/en/lr/01222/">CIOMS I Generation Data Mapping</a>

### 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`<br>
`AND`<br>
`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.

### 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.

### Controlled Vocabulary Codelist

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

**Related Articles**:

* <a href="/en/lr/01195/">Configure Controlled Vocabularies</a>

## D

### 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.

**Related Articles**:

* <a href="/en/lr/01192/">Configure Adverse Event Watchlists</a>
* <a href="/en/lr/01158/">How Case Watchlist Tags and DMEs are Assigned</a>

### Development Safety Update Report (DSUR)
A Development Safety Update Report is 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.

**Related Articles**:

* <a href="/en/lr/01280/">Create DSUR Aggregate Reports</a>

### Due Date

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

## E

### E2B(R2)

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

**Related Articles**:

* <a href="/en/lr/01288/#ich-e2b-r2">ICH E2B(R2) Generation Data Mapping</a>

### E2B(R3)

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

**Related Articles**:

* <a href="/en/lr/01288/#ich-e2b-r3">ICH E2B(R3) Generation Data Mapping</a>

### European Medicines Agency (EMA)

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

## F

### 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.

**Related Articles**:

* <a href="/en/lr/01224/">Generate a Regulatory Report</a>
* <a href="/en/lr/802644/">FDA MedWatch 3500A Generation Data Mapping</a>

### 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.

## G

### Gateway: AS2

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

### Gateway: AS2 Connection

A connection type used for connecting Safety to an Agency or Trading Partner's AS2 gateway.

**Related Articles:**

* <a href="/en/lr/703946/">AS2 Connections Overview</a>

### Gateway: AS2 E2B ACK

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

**Related Articles**:

* <a href="/en/lr/01266/">Send a Gateway Transmission</a>
* <a href="/en/lr/01245/">Standard Agency ICSR Submissions</a>
* <a href="/en/lr/01286/#ack-generation-mapping">Receive an E2B Transmission: ACK Generation Mapping</a>

### Gateway: AS2 MDN

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

**Related Articles**:

* <a href="/en/lr/01266/">Send a Gateway Transmission</a>
* <a href="/en/lr/01245/">Standard Agency ICSR Submissions</a>

### Gateway: FDA ESG

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

**Related Articles**:

* <a href="/en/lr/01205/">Configure FDA Gateway</a>

### Gateway: EU EMA EV

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

**Related Articles**:

* <a href="/en/lr/01203/">Configure EMA Gateway</a>

## I

### ICSR

Individual Case Safety Reports

### <a id="idf"></a>Iyakuhinmei Data File (IDF)

The IDF allows you to code products and report safety data to the Pharmaceuticals and Medical Devices Agency (PMDA). The IDF may also be referred to as [Japan Drug Dictionary (JDD)][1] or JDrug.

### IDMP

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.

**Related Articles**:

* <a href="/en/lr/01217/">Migrate External Cases</a>

### In-Flight Case

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

## J

### <a id="jdd"></a>Japan Drug Dictionary (JDD)

JDD and JDrug are the colloquial names for the [Iyakuhinmei Data File (IDF)][2].

## K

### <a id="kdd"></a>Korea Drug Dictionary

Korea Drug Dictionary is the name for the drug dictionary maintained by the Korean Ministry of Food and Drug Safety (MFDS), which includes Korea-specific drug codes. The Korea Drug Dictionary allows you to code products and report safety data to the MFDS.

**Related Articles**:

* <a href="/en/lr/827540/">Code Korea Drug Dictionary Products</a>

## M

### <a id="mah"></a>MAH

Market Authorization Holder.

**Related Articles**:
* <a href="/en/lr/01255/">Manage MAH Distribution Lists</a>

### <a id="meddra-dictionary"></a>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, diseases, indications, and adverse events.

**Related Articles**:

* <a href="/en/lr/01187/">Manage the MedDRA Dictionary</a>
* <a href="/en/lr/01164/">Code MedDRA Terms</a>

### MedDRA/J {#meddra-j}
The Japanese translation of the MedDRA dictionary.

### MedDRA/J Currency {#meddra-j-currency}
In the context of MedDRA/J, MedDRA/J currency refers to a method of denoting the preferred English translation for a Japanese MedDRA LLT term. MedDRA/J refers to the preferred translation as current and non-preferred translations as non-current. For example, 発熱 translates to both fever and pyrexia. Pyrexia is considered the current term.

**Related Articles**:

* <a href="/en/lr/01164/">Code MedDRA Terms</a>

### <a id="mpid"></a>Medicinal Product Identifier (MPID)

The MPID refers to drug codes maintained by WHODrug and used in reporting to most global agencies.


## N

### Narrative

Narratives for ICSRs are detailed descriptions that chronologically summarize adverse events or reactions experienced from a specific product. Narratives include clinical details, causality assessment, outcomes, and management information.

**Related Articles**:
* <a href="/en/lr/01167/">Generate a Case Narrative</a>

## P

### Parent Information

_Parent Information_ is a type of _Case_ object used for cases involving children where parental information is required (for example, medical and drug history) but the parent themselves have not experienced an adverse event.

**Related Articles**:

* <a href="/en/lr/01149/">Process Pregnancy Cases, Child Information & Parent Information</a>

### PBRER

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

**Related Articles**:

* <a href="/en/lr/01282/">Create PBRER Aggregate Reports</a>

### PMOA

PMOA stands for Primary Mode of Action and identifies which constituent part provides the primary therapeutic action of the combination product. Admins set product constituents as the PMOA through the _PMOA_ field on _Product Registrations_.

**Related Articles**:

* <a href="/en/lr/01214/">Manage Combination Products</a>

### 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`<br>
`AND`<br>
`study_product_reason__v.controlled_vocabulary__v.e2b_code__v = {2 OR 3}`

### Pregnancy Case

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

**Related Articles**:

* <a href="/en/lr/01149/">Process Pregnancy Cases, Child Information & Parent Information</a>

### Product Constituent

A single drug, device, or biologic component within a combination product. These are also known as "constituent parts." Admins manage these using the _Product Constituent_ object.

**Related Articles**:

* <a href="/en/lr/01214/">Manage Combination Products</a>

### Product Registration

The **Product Registration** object contains information specific to a registration with a health authority authorizing a product to be distributed within a country.

**Related Articles**:

* <a href="/en/lr/01215/">Manage Products</a>

## R

### Routes of Administration

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.

## S

### 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`

### Study Selector

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

## T

### Transmission Type: Distribution

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

**Related Articles**:

* <a href="/en/lr/01264/">ICSR Transmissions Overview</a>
* <a href="/en/lr/1022564/">Create an ICSR Transmission</a>

### Transmission Type: Early Notification

A type of outbound Transmission for an ICSR where the target is an agency or partner organization with whom you have an agreement to share _Case_ details early in the _Case_ lifecycle.

**Related Articles**:

* <a href="/en/lr/01264/">ICSR Transmissions Overview</a>
* <a href="/en/lr/1022564/">Create an ICSR Transmission</a>

### Transmission Type: Inbound Transmission

A type of _Transmission_ that contains the details of an inbound ICSR.

**Related Articles**:

* <a href="/en/lr/01286/">Receive an E2B Transmission</a>
* <a href="/en/lr/907890/">Inbound Transmission Overview</a>

### Transmission Type: Submission

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

**Related Articles**:

* <a href="/en/lr/01264/">ICSR Transmissions Overview</a>
* <a href="/en/lr/1022564/">Create an ICSR Transmission</a>
* <a href="/en/lr/01245/">Standard Agency ICSR Submissions</a>

## U

### Unblinding

Unblinding content, such as cases, products, and narratives, makes the content accessible by certain users with appropriate permissions. When you unblind content, Vault 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.

## V

### 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.

## W

### WHODrug Dictionary

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

**Related Articles**:

* <a href="/en/lr/01190/">Manage the WHODrug Dictionary</a>
* <a href="/en/lr/01165/">Code WHODrug Products</a>

[1]: #jdd
[2]: #idf