MedDRA Classification Detail View

The MedDRA classification Detail View page displays all of the terms in a flat structure. You import the MedDRA dictionary files into Market Registration, and can later update it when a new version is released. After updating the dictionary, you can run an Impact Analysis to determine if any updates affect any of your submissions.

Required access role: Regulatory Administrator, Regulatory Lead, or Regulatory User

To access and load data into the list of all classifications:

Click > MedDRA Classification > Detail View.
Note: Because of the large number of entries in the MedDRA dictionary, this page does not list any terms until you enter filter criteria.
Click Refinements to open the Detail View - Refinements pane.
Enter text in any combination of the filters, then click Filter.
When entering criteria, you must type at least 3 characters. You can use the * wildcard. For example, you can enter Car* in the SOC filter, and the app finds all entries for Cardiac Disorders.

To view the list of classifications for an indication:

Open the indication. See Indications Page.
Click the MedDRA Classification category.

This topic describes:

This page discusses:

Columns
Actions/Toolbar Commands for MedDRA Classification View Pages
Actions/Toolbar Commands for MedDRA Classification Category for an Indication

Columns

Each row in the table shows the full dictionary hierarchy for the preferred term.


Column Name	Description
SOC Name	Name of the system organ class.
SOC Code	The code associated with this system organ class.
HLGT Name	Name of the high level group term.
HLGT Code	The code associated with this high level group term.
HLT Name	Name of the high level term.
HLT Code	The code associated with this high level term.
PT Name	Name of the preferred term.
PT Code	The code associated with this preferred term.
LLT Name	Name of the low level term.
LLT Code	The code associated with this low level term.
LLT Current	Indicates whether the low level term is current. If this columns shows N (for No), then the current version of the dictionary changed the terms defined by a prior version. You can run an impact analysis report to determine if the change affects any of your products.
Primary SOC	Indicates whether this the primary SOC for the preferred term.
MedDRA Version	Specifies the version of the MedDRA dictionary.

Actions/Toolbar Commands for MedDRA Classification View Pages


Action Name	Description	For More Information
Import Dictionary/Upgrade Dictionary	Imports the MedDRA dictionary for the first time or imports an upgraded dictionary. Required access role: Regulatory Administrator	Importing or Upgrading the MedDRA Dictionary
Impact Analysis	Opens a report that lists the submission master records that could be affected if the selected dictionary items are changed. Required access role: Regulatory Administrator	Analyzing the Impact of Changed Terms in MedDRA
MedDRA Version	Allows you to select a dictionary version. Only installed versions are listed. The terms associated with the selected dictionary version are shown on the page. Required access role: Regulatory User	-

Actions/Toolbar Commands for MedDRA Classification Category for an Indication


Action Name	Description	For More Information
Add Classification	Allows you to search for and add an MedDRA classification to the selected indication. Required access role: Regulatory Lead	Assigning a MedDRA Classification to an Indication
Remove Classification	Removes the selected classification from the list. Required access role: Regulatory Lead	-