Review existing MedDRA synonyms
To ensure accurate and efficient reporting and analysis, it is crucial to have a well-curated and organized MedDRA synonym database. One of the key steps in managing this database is reviewing the existing MedDRA synonyms to identify potential duplicates, view details about specific synonyms, and ensure that the appropriate MedDRA codes are assigned to each term.
-
In the PV application header, select the CONFIGURATION tab.
-
In the left pane, select MedDRA Synonym.
Figure 1. Accessing MedDRA synonym configuration
-
In the MedDRA Synonym table that appears, view the existing MedDRA synonyms as explained in the following table.
Figure 2. Reviewing MedDRA synonym database
Column
Details
Column with a checkbox
If you need to download specific MedDRA synonyms as an Excel file, select the checkboxes next to the MedDRA synonyms you need and then, from the workspace toolbar, select Export
.This may be necessary if, for example, there is no stable Internet connection but you need to work on MedDRA synonyms, or if you need to share the list of MedDRA synonyms with someone who is not a user of the PV application.
Status
Represents the status of the MedDRA synonym:
-
Active
: the synonym is currently being used within the PV application to classify and report terms or
data. -
Inactive
: the synonym is not currently being used within the PV application to classify and report
terms or data.
Verbatim Term
Represents a specific literal term or condition as reported by the reporter.
For example, a verbatim term for a headache may be "head hurts", which is not included in the MedDRA terminology. By configuring "head hurts" as a synonym for the MedDRA term for headache, users can more accurately capture and classify this specific type of headache in their pharmacovigilance data.
MedDRA Version
Represents a specific version of MedDRA that corresponds to the specific MedDRA synonym.
Different versions of MedDRA may contain variations in terms, codes, or hierarchies, so it is important to ensure that all synonyms are labeled with the correct version to avoid confusion or errors when analyzing adverse events or medical conditions.Language
Represents a language in which a specific synonym is written.
For example, a MedDRA term for "headache" may have synonyms available in English, French, and Spanish. When a user enters a verbatim term for "headache" in any of these languages, the PV application will be able to accurately classify the event using the appropriate MedDRA term and synonym.
LLT Code
Represents a unique code that is assigned to the Lowest Level Term (LLT) and that corresponds to the specific MedDRA synonym set.
LLT is the most granular level of term in the MedDRA hierarchy. It provides the greatest level of specificity in the terminology.LLT Term
Represents the name of the lowest level term that corresponds to the specific MedDRA synonym set. For example, "Abdominal discomfort", "Anaphylactic reaction", "Hypersensitivity vasculitis", and so on.
SOC Code
Represents a unique code assigned to the SOC (System Organ Class) category.
SOC is the highest level of the MedDRA hierarchy. It is a broad category used to group together related medical conditions and AEs. Examples of SOC categories include "Infections and infestations", "Nervous system disorders", and "Musculoskeletal and connective tissue disorders".SOC Term
Represents a standardized term used to describe the SOC category.
PT Code
Represents a code assigned to the Preferred Term (PT).
PT is a level of the MedDRA hierarchy that provides a standardized way of describing medical conditions and adverse events (AEs) in clinical trials and pharmacovigilance activities. Each PT represents a single medical concept, such as a symptom, sign, disease, or AE.PT Term
Represents a standardized term used to describe the medical concept represented by the PT.
HLT Code
Represents a unique code assigned to the High-Level Term (HLT).
HLT is a level of the MedDRA hierarchy that provides a way of grouping related Preferred Terms (PTs) together. Each HLT represents a concept that encompasses multiple PTs that are related in terms of clinical presentation or etiology.HLT Term
Represents a standardized term used to describe the concept represented by the HLT.
HLGT Code
Represents a unique code assigned to the High-Level Group Term (HLGT).
HLGT is a level of the MedDRA hierarchy that provides a way of grouping related High-Level Terms (HLTs) together.HLGT Term
Represents a standardized term used to describe the concept represented by the HLGT.
Creator
Represents the username of the user who has created a MedDRA synonym.
Create Time
Represents the date and time when the MedDRA synonym has been created.
Modified Date
Represents the date and time when the MedDRA synonym has been updated.
Modified By
Represents the username of the user who has updated a MedDRA synonym.
-
Tip
To help you streamline the management and analysis of MedDRA synonyms, making it easier to find and work with the data that is most relevant to your needs, from the workspace toolbar, select one of the following options:
-
Columns
: to hide any unnecessary columns and display only the
specific columns that you need for your work or analysis. -
Filter
: to set filters and display only the MedDRA synonyms that are of interest to
you.