In addition to the Vault Safety-specific terms listed on this page, see Glossary of Vault Terms 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.
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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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- Aggregate Reports Overview
- Configure Aggregate Reporting Families
- Configure Aggregate Report Templates
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.
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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.
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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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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.
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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.
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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.
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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.
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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
Causality refers to the relationship of a given adverse event to a specific drug.
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Child Information Case
A Child Information Case is a type of Case object Vault creates when a user opens a pregnancy Case. Child Information Cases track birth outcomes and test results when there is no adverse event in the child.
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CIOMS I
A standard of ICH that is used for worldwide submissions of Clinical Trial and Post Marketed Adverse Events.
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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
AND
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.
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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.
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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.
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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).
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E2B(R3)
An ICH Standard for electronic data exchange of ICSRs (Release 3).
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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.
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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 Vault Safety Connection type used for connecting Vault Safety to an Agency or Trading Partner’s AS2 Gateway.
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Gateway: AS2 E2B ACK
Acknowledgment message when an E2B file has been accepted by the trading partner.
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- Send a Gateway Transmission
- Standard Agency ICSR Submissions
- Receive an E2B Transmission: ACK Generation Mapping
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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I
ICSR
Individual Case Safety Reports
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) 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.
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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).
J
Japan Drug Dictionary (JDD)
JDD and JDrug are the colloquial names for the Iyakuhinmei Data File (IDF).
M
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.
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P
Parent Information Case
A Parent Information 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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PBRER
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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PMOA
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
AND
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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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
The Product Registration object contains information specific to a registration with a health authority authorizing a product to be distributed within a country.
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R
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.
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, 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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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.
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