MedDRA Desktop Browser 4.1

User Guide

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15 May 2019

Acknowledgements

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Acknowledgements

MedDRA® trademark is owned by IFPMA on behalf of ICH.

Table of Contents 
 
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Table of Contents 
INTRODUCTION ......................................................................................... 1 
MedDRA Desktop Browser 4.1 .................................................................... 2 
INSTALLATION OF THE MEDDRA DESKTOP BROWSER ...................... 1 
1 SYSTEM REQUIREMENTS ........................................................... 1 
2 uninstalling previous MedDRA Desktop Browser ............................ 1 
3 access and install the MDB ............................................................. 1 
4 Loading MedDRA files into the MDB ............................................... 3 
5 Setting Language Interface Version Preferences ............................ 4 
6 Removing Files ............................................................................... 7 
7 Adjusting the Interface .................................................................... 7 
MEDDRA DESKTOP BROWSER SCREEN ............................................... 1 
1 MDB Configuration Options ............................................................ 2 
SEARCHING ............................................................................................... 4 
1 Search results panel features ......................................................... 7 
2 Go to browser.................................................................................. 7 
3 Search by code ............................................................................... 8 
4 Select SOCs to search .................................................................... 9 
5 SMQ search .................................................................................. 10 
ADDITIONAL SEARCH FEATURES ........................................................ 13 
1 Export search results .................................................................... 13 
2 Search in multiple languages ........................................................ 14 
3 Synonym list .................................................................................. 17 
4 Ignore diacritical marks ................................................................. 18 
5 VCR buttons .................................................................................. 19 
6 Clear search .................................................................................. 19 
7 Cancel ........................................................................................... 19 
8 SMQ Analysis................................................................................ 19 
9 Hierarchy Analysis ........................................................................ 22 
USEFUL FEATURES ................................................................................ 24 

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6.1 History function ............................................................................. 24 
6.2 Copy term / Copy code ................................................................. 25 
6.3 Open details and occurrences....................................................... 26 
6.4 Research bin ................................................................................. 27 
6.5 Export research bin to spreadsheet .............................................. 31 
6.6 IMport a previously exported research bin .................................... 33 
6.7 SMQ Export .................................................................................. 34 
7. MEDDRA/J SPECIFIC FUNCTIONS ......................................................... 37 
7.1 Kana / Kanji ................................................................................... 37 
7.2 J-currency ..................................................................................... 39 
7.3 MedDRA/J Synonyms – they are displayed below the LLT level .. 41 
7.4 MedDRA/J Legend ........................................................................ 47 
APPENDIX A. MEDDRA DESKTOP BROWSER FEEDBACK FORM .............. 48 
  
 
 
 
List of Figures  
Figure 2-1.  Import MDB Screen ........................................................................... 2 
Figure 2-2.  Import MDB Screen with Selected Data File ..................................... 2 
Figure 2-3.  Main MDB Screen Populated with MedDRA Terminology ................ 3 
Figure 2-4.  Import MedDRA Files ........................................................................ 3 
Figure 2-5.  Import MDB Screen ........................................................................... 4 
Figure 2-6.  MDB Preferences Menu .................................................................... 4 
Figure 2-7.  Changing User Interface Preference ................................................. 5 
Figure 2-8.  MDB with the Chinese User Interface ............................................... 6 
Figure 2-9.  Selecting multiple languages at start up ............................................ 6 
Figure 2-10.  Removing MedDRA Files ................................................................ 7 
Figure 2-11.  Selecting Files to Remove............................................................... 7 
Figure 2-12.  Adjusting the MDB Interface............................................................ 8 
Figure 2-13.  MDB with the configuration panel removed ..................................... 8 
Figure 2-14.  Restoring Panels ............................................................................. 9 
Figure 3-1.  Components of the MDB Screen ....................................................... 1 
Figure 3-2. MDB Configuration Options ............................................................... 2 
Figure 4-1. MDB Search Screen .......................................................................... 4 
Figure 4-2. MDB Search Results .......................................................................... 5 
Figure 4-3. Synonym List...................................................................................... 6 
Figure 4-4. Search Options .................................................................................. 7 
Figure 4-5. Search Results Panel Features.......................................................... 7 
Figure 4-6. Go to Browser Results ....................................................................... 8 

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Figure 4-7. Secondary Link .................................................................................. 8 
Figure 4-8. Search by Code ................................................................................. 9 
Figure 4-9. Select SOC to Search ........................................................................ 9 
Figure 4-10. Select Multiple SOCs to Search ..................................................... 10 
Figure 4-11. SMQ View Option ........................................................................... 10 
Figure 4-12. Search SMQs ................................................................................. 11 
Figure 4-13. Search SMQ Term Codes .............................................................. 12 
Figure 5-1. Export Search Results ..................................................................... 13 
Figure 5-2. Search Results Display .................................................................... 14 
Figure 5-3. Selecting Multiple Languages .......................................................... 15 
Figure 5-4. Search Results in Multiple Languages ............................................. 16 
Figure 5-5. Search Language Option Menu ....................................................... 17 
Figure 5-6. View Specific Language Synonym List ............................................ 18 
Figure 5-7. Chinese Translation Synonym List ................................................... 18 
Figure 5-8. Ignore Diacritical Marks .................................................................... 19 
Figure 5-9. VCR Buttons .................................................................................... 19 
Figure 5-10. Clear Search .................................................................................. 19 
Figure 5-11. SMQ Analysis Options ................................................................... 20 
Figure 5-12. SMQ Analysis Input Data ............................................................... 21 
Figure 5-13. SMQ Analysis Report ..................................................................... 21 
Figure 5-14. Hierarchy Analysis Options ............................................................ 22 
Figure 5-15. Hierarchy Analysis Inputs ............................................................... 23 
Figure 5-16. Hierarchy Analysis Report .............................................................. 23 
Figure 6-1. Open History .................................................................................... 24 
Figure 6-2. Open History Results ....................................................................... 25 
Figure 6-3. Copy Term ....................................................................................... 25 
Figure 6-4. Open Details & Occurrences ............................................................ 26 
Figure 6-5. Term Details in Primary Language ................................................... 27 
Figure 6-6. Add to Research Bin ........................................................................ 28 
Figure 6-7. Add Multiple Groups to Research Bin .............................................. 29 
Figure 6-8. Remove Terms From Research Bin ................................................. 29 
Figure 6-9. Add Sub-categories to Research Bin ............................................... 30 
Figure 6-10. My Research Bin ............................................................................ 31 
Figure 6-11. Research Bin Label ........................................................................ 32 
Figure 6-12. Export Spreadsheet ....................................................................... 32 
Figure 6-13. Import Previously Exported Spreadsheet ....................................... 33 
Figure 6-14. Imported Terms Results ................................................................. 34 
Figure 6-15. SMQ Export.................................................................................... 35 
Figure 6-16. Include Inactive Terms ................................................................... 35 
Figure 6-17. SMQ Export Spreadsheet .............................................................. 36 
Figure 7-1. Select Language Option ................................................................... 37 
 

Introduction

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1. INTRODUCTION

Welcome to the MedDRA® Desktop Browser (MDB) User Guide. This guide has been

developed to familiarize the reader with the use of the MedDRA Desktop Browser.

The MDB is designed to review the MedDRA hierarchy and SMQs, and perform term

searches for coding and analysis tasks in English and available translated languages.

This guide assumes the viewer has a basic understand of how MedDRA is used for

regulatory reporting and analysis, and knowledge of MedDRA’s hierarchical structure.

All examples given in this manual utilize MedDRA Version 22.0. This guide assumes

you have stored the MedDRA data files on your hard drive or local area network. If

you do not have access to the data files, please contact your system administrator.

The MedDRA Desktop Browser 4.1 has been developed using the Microsoft

Windows® .Net™ 4.0 platform. The MedDRA Desktop Browser has been developed

to be compatible with Windows® 7 and above. It was tested using the U.S. version of

Windows 10. If the reader uses the MedDRA Desktop Browser with other versions of

Windows and experiences any difficulties; please contact the MSSO (internationally)

via a toll-free number listed below.

For more information about the MedDRA Desktop Browser, questions, or comments

about this guide, please contact the MedDRA MSSO at:

Email: mssohelp@meddra.org

Toll Free International: +1 877.258.8280

Direct: +1 703.556.2950

Fax: +1 703.556.1744

MedDRA Desktop Browser 4.0 (previous version)

The MedDRA Desktop Browser 4.0 has the following enhanced features:

 The user interface has been modified to match the Web-Based Browser

 Users have the option to change the user interface language to any of the currently

supported MedDRA languages

 Search results are grouped by default into four search categories for easier review

– exact match, lexical variant, synonym and contains search results

 Users may view up to three languages at one time

 Search results will display in multiple languages, if selected

 Hierarchy information is included with research bin and search results exports

 The synonym search results has been enhanced from the 3.1.0b version

 Access to on-line resources including the latest version of the MedDRA concept

descriptions, MedDRA documentation and an html version of this user guide.

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 The desktop browser has been enhanced to take advantage of the unique features

of Japanese MedDRA.

MedDRA Desktop Browser 4.1

The MedDRA Desktop Browser 4.1 has the following enhanced features:

 The user can perform SMQ Analysis and Hierarchy Analysis functions

 The user has the option to perform a more complex search operation

 Secondary SOC data can be extracted when exporting Research Bin, search

results, and Hierarchy Analysis report

 Data can be exported in all user-selected languages

The MSSO encourages users to provide feedback. This includes identification of

software defects as well as suggestions for new or modified capabilities. Please use

the MedDRA Desktop Browser Feedback Form in Appendix A. Your comments and

suggestions are appreciated.

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2. INSTALLATION OF THE MedDRA DESKTOP BROWSER

This section describes basic MedDRA Desktop Browser installation procedures and

contains the following:

 System requirements

 Uninstalling previous MedDRA Desktop Browser

 Installation procedures for running on an individual computer workstation

If your computer does not meet these requirements, please see your system

administrator.

2.1 SYSTEM REQUIREMENTS

Before installing the MedDRA Desktop Browser, your system must meet the following

minimum requirements:

 Microsoft Windows 7 or greater

 1 GB RAM

 .NET 4.0 Framework

 40 MB of room available on hard disk

If your computer does not meet these requirements, please see your system

administrator.

2.2 UNINSTALLING PREVIOUS MedDRA DESKTOP BROWSER

MDB version 4.0 does not need to be removed or uninstalled to use MDB 4.1.

However, users may remove version 4.0 by deleting the folder containing the

executable file. Versions 3.0 and prior were bundled as an install package and can be

uninstalled if desired. Follow the steps below to remove versions prior to 3.0 of the

desktop browser.

1. Go to Start…Settings…Control Panel

2. Double-click the Add/Remove Programs icon

3. Highlight MedDRA Desktop Browser in the open list box

4. From the welcome screen options, choose Remove

5. A confirmation will appear. Choose Yes to uninstall the Browser.

2.3 ACCESS AND INSTALL THE MDB

The MedDRA MDB is a free tool that is part of your MedDRA subscription.

Follow the steps listed below to download and install the MDB application:

1. Go to the MedDRA Desktop Browsers web page (MedDRA ID and password

required)

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2. Click on the Download link found in the right kiosk.

3. Unzip the MDB files to a folder on your PC.

4. Double click on MEDDRABROWSERWIN.exe. (Note: A shortcut can be created

to the executable the desktop for convenience).

You will be presented with the Import MedDRA Data screen.

Figure 2-1. Import MDB Screen

Make sure that the MedDRA release file is already unzipped in a folder. Unzipping the

release file will require an Unzip Password which can be retrieved from the MedDRA

Self-Service Application. Navigate to the directory where you store the MedDRA data

files, select the data files folder, and press OK The Version and Language fields will

be automatically filled in with the language and version selected. Press the Import

button. The data files will be loaded into the MDB.

Figure 2-2. Import MDB Screen with Selected Data File

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You will be presented with the main MDB screen populated with MedDRA

Terminology.

Figure 2-3. Main MDB Screen Populated with MedDRA Terminology

2.4 LOADING MedDRA FILES INTO THE MDB

To load additional MedDRA versions into the MDB, select “Import MedDRA data from

ASCII files” from the “File” menu.

Figure 2-4. Import MedDRA Files

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You will be presented with the Import MedDRA Data screen.

Figure 2-5. Import MDB Screen

Navigate to the directory where you store the MedDRA data files, select the data files

folder, and press OK. The Version and Language fields will be automatically filled in

with the language and version selected.

Press the Import button. The data files will be loaded into the MDB.

You will be presented with the main MDB screen populated with MedDRA

Terminology. Repeat for additional versions and languages.

2.5 SETTING LANGUAGE INTERFACE VERSION PREFERENCES

There are two preferences that can be set when working in the MDB. To access the

preferences screen, select “Set Preference” from the “File” menu.

Figure 2-6. MDB Preferences Menu

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First, users may change the user interface language from English to one of the

currently supported MedDRA languages. To do this, select a language from the

“Preferred Language (User Interface)” drop down menu. See the item A in the figure

below.

Figure 2-7. Changing User Interface Preference

After clicking “OK” (language equivalent) – item B, the language interface for the

MDB will change to the language selected. See the figure below for an example.

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Figure 2-8. MDB with the Chinese User Interface

The second option available is setting which language versions to load when starting

the MDB. Users may select up to three languages to load at startup which will

appear in the hierarchy view of the MDB. See Section 5.2 for more information on

viewing and searching in multiple languages versions of MedDRA.

Figure 2-9. Selecting multiple languages at start up

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There are two prerequisites for selecting multiple languages at start up. First, the

language versions of MedDRA must be loaded into the MDB as described in Section

2.4. Second, all languages selected must be the same version. For example, if

English, Dutch, and French are selected to load at start up, all three languages must

be the same version (e.g., MedDRA Version 18.0).

2.6 REMOVING FILES

To remove previously loaded files, select “Remove MedDRA Data” as shown in the

figure below.

Figure 2-10. Removing MedDRA Files

Then select which language version of MedDRA to remove and click the “Remove”

button as shown below. Files can be reloaded at any time using the procedure

described in Section 2.4.

Figure 2-11. Selecting Files to Remove

2.7 ADJUSTING THE INTERFACE

The MDB interface may be adjusted by removing panels to create more working

space. Panels may be removed by clicking on “X” located to the right of the

hierarchy, configuration options and search panels. See section 3 for a description

of each panel in the MDB.

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Figure 2-12. Adjusting the MDB Interface

Clicking the “X” removes a panel.

Figure 2-13. MDB with the configuration panel removed

To restore all panels, select “All” from the view menu.

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Figure 2-14. Restoring Panels

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3. MedDRA DESKTOP BROWSER SCREEN

Figure 3-1. Components of the MDB Screen

The sections below describe the five panels of the MDB.

A. At the top are MDB configuration options and useful information. These include the

ability to change languages, MedDRA version, and switch between SOC and SMQ

view.

B. To the left is the MedDRA hierarchy panel where one can browse the hierarchy by left

clicking the plus symbol next to each term to drill down to the LLT level.

Just above the MedDRA hierarchy panel is the Term Navigation panel, which displays

hierarchy information and reduces the need to scroll up to recall which SOC or HLGT

you are browsing in.

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C. In the middle is the search panel where words or MedDRA codes may be entered to

search for MedDRA terms.

D. The bottom / middle is where the search results are displayed

E. To the right is term detail information. When clicking on a MedDRA term in the hierarchy

panel (B) or in search results (D), the term details display in this far right panel.

3.1 MDB CONFIGURATION OPTIONS

The MDB configuration and information options are shown below.

Figure 3-2. MDB Configuration Options

MedDRA Concept Descriptions*

– links to the current list of concept descriptions as found in Appendix B of the MedDRA

Introductory Guide.

Legends

– an explanation of the color codes used to convey hierarchical link information or term status in

both the SOC view and the SMQ view

About

– name, version, and copyright information

Search history

– retrieve the history a term by entering into the field provided

New browser window

– opens a new browser window, which is useful for comparing two different versions of MedDRA

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MedDRA Documentation*

– links to MedDRA Release support documentation found on the MedDRA website

User Guide*

– links to this document

Language and Version Options

– provides views of up to three supported languages simultaneously

Browser View SOC vs. SMQ

– default will show the SOC view of MedDRA; SMQ view displays the SMQ information in the

hierarchy panel on the left

Display Options

– Show Codes displays the MedDRA code next to each term

– By default, the MDB will show non-current LLTs, which are depicted with a red square and

lettering.

*Note: An Internet connection is needed to access the MedDRA concept descriptions,

documentation, and the user guide.

Searching

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4. SEARCHING

This section describes how to perform searches in the MDB, and explains the

search functions in the search panel.

Figure 4-1. MDB Search Screen

To search, enter a term or word in the Search field (C).

The search function performs a logical and operation and return terms with those

words found in any order.

When results are returned, a summary of the search results appears (D) showing

the total number of terms returned and a hierarchical breakdown of results – for

example how many LLTs, PTs, HLTs, etc.

Similarly, the results are divided into separate tabs according to their place in the

MedDRA headachy. – LLT, PT, HLT, etc.

LLTs will show first if there are any in a search result.

Searching

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By default, a search will break up returned results into four search categories at the

PT and LLT level.

To perform a complex search, click on the “Advanced Search” button and then

select the preferred grouping and Boolean operators.

To revert back to simple searches, click on the “Basic Search” button.

Figure 4-2. MDB Search Results

 Exact match – result matches exactly what was typed into the search field

 Lexical variant – returns different word order of words typed into the search

field. In the example above a search for “liver failure” returned the lexical

variant “failure liver”.

 Synonym search results – return results based on the associated synonym

list file. Notice the search for liver failure returned terms that contain hepatic in

them.

o Synonyms are returned based on predefined synonym groups that may be

viewed by clicking the “Use Synonym List” link found in the search panel

(C).

Searching

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Figure 4-3. Synonym List

o These pairings have been tested to ensure they bring up appropriate

associations. For example, “liver” terms return “hepatic”; “kidney terms”

return “renal terms”; and vice versa.

o The synonym search function may be disabled by unchecking the check

box to the left of “Use Synonym List.”

Searching

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Figure 4-4. Search Options

 Contains search results – terms that contain word or words entered in

the search field.

If you prefer to not group research results according to the search categories, this

function may be disabled by unchecking “Show PT/LLT with categories” option

which will return results in alphabetical order.

4.1 SEARCH RESULTS PANEL FEATURES

To view the hierarchy of higher level terms and multi-axial links, expand the search

results. The primary SOC is designated with a blue square.

Figure 4-5. Search Results Panel Features

4.2 GO TO BROWSER

The “Go to Browser” function shows the user the exact place in the MedDRA

hierarchy a term resides. To use this feature, right click on a term in the search

results panel (e.g., PT Cardiac death) and choose “go to browser.” A second

browser window pops up displaying the hierarchy information.

Searching

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Figure 4-6. Go to Browser Results

In this case there are two links – a primary link to SOC General disorders and

administration site conditions which is designated by the blue box surrounding the

“SOC” icon, and a secondary link to SOC Cardiac disorders. To see a specific link,

click on the term name to go to that area within the MedDRA hierarchy.

For example, to see the secondary link in the MedDRA hierarchy, double click on the

PT Cardiac death in the secondary link to see the surrounding LLTs and PTs.

Figure 4-7. Secondary Link

4.3 SEARCH BY CODE

In addition to words, one may also enter a MedDRA code in the search field to

search by code.

Searching

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Figure 4-8. Search by Code

4.4 SELECT SOCS TO SEARCH

To limit which SOCs to search from, select one or more SOC(s) from the “Select

SOCs to search” window. For example, if you were interested in investigation terms

and did not want terms from other SOCs, select the Investigation SOC to limit

searches to this single SOC.

Figure 4-9. Select SOC to Search

Multiple groups of SOCs can be selected by holding down the shift key and clicking

on SOC names.

Individual SOCs can be selected by holding down the CTRL key to multi-select

those SOCs to be included in the search.

Notice that when a search is limited to a subset of the SOCs, there is a yellow

highlighted message informing the user of the number of SOCs selected.

Searching

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Figure 4-10. Select Multiple SOCs to Search

To search all SOCs again, click the “Clear Selection” button.

4.5 SMQ SEARCH

Performing searches for SMQs is similar to performing searches in the SOC view.

First switch the browser view to SMQ view.

Figure 4-11. SMQ View Option

Enter a word or words to search in the search field.

Searching

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Figure 4-12. Search SMQs

As explained in the SOC view examples above, one can search for MedDRA term

codes and - specific to the SMQ view – SMQ codes may be entered for searching.

Enter the SMQ code in the Search Options screen and press Search.

Searching

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Figure 4-13. Search SMQ Term Codes

Useful Features

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5. ADDITIONAL SEARCH FEATURES

In addition to the above search functions, there are additional search features

available in the MDB.

5.1 EXPORT SEARCH RESULTS

To export all search results to a spreadsheet, after performing a search, click on

“Export” in the Search Options screen.

Figure 5-1. Export Search Results

A popup window appears displaying the search results. Primary SOC hierarchical

information is included by default. Options to include secondary SOC and HLGT and HLT

information are available. To exclude secondary SOC or the higher level terms uncheck

these options. Click “Export” to export to a spreadsheet. Note that MS Excel or compatible

spreadsheet software must be installed on your computer for this feature to work.

Useful Features

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Figure 5-2. Search Results Display

To limit the export to only a subset of search terms, please refer to Section 6.4

RESEARCH BIN and Section 6.5 EXPORT RESEARCH BIN TO SPREADSHEET.

5.2 SEARCH IN MULTIPLE LANGUAGES

The MDB has the capability of searching in three supported languages. From the

Configuration options fields, choose up to three languages. To search or view two

languages only, simply make two of the three language choices the same. In the

example below, three languages have been selected in the following order: Chinese,

English, and French. The selected languages will appear in the hierarchy panel in

the order which they have been selected.

Useful Features

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Figure 5-3. Selecting Multiple Languages

The left most language selected is considered the primary language which means

that information options used in the MDB will be presented in this language such as

term detail information, term history, copy term, and the MedDRA concept

descriptions.

One can see what language the browser is set to search by looking to the left of the

search field. Type in a Chinese word to search (免疫系统疾病). The search returns

items with the Chinese words. Because English and French were also selected, the

corresponding English and French terms appear below the Chinese terms in the

search results panel.

Useful Features

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Figure 5-4. Search Results in Multiple Languages

The language to search can be changed by using the drop down menu to the left of

the search field. Only the languages selected in the language options menu will

appear. In the example below, the search language was changed to English.

Notice that the corresponding Chinese and French term names appear in the search

results and the Term Details in Primary Language pane shows term detail

information in Chinese.

Useful Features

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Figure 5-5. Search Language Option Menu

5.3 SYNONYM LIST

There is an associated synonym list for each of the supported languages. To view

this list, click on the “Use Synonym List” link in the search panel.

To view a list to a specific language, that language must be the primary language

selected.

Useful Features

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Figure 5-6. View Specific Language Synonym List

A popup screen appears with the synonym list for the selected language.

Figure 5-7. Chinese Translation Synonym List

The synonym search function can be disabled by unchecking the “Use Synonym

List” feature.

5.4 IGNORE DIACRITICAL MARKS

By default, the “ignore didactical marks” option is enabled for searching. This means

that diacritical marks such as accents, tildes, and umlauts used in non-English Latin

alphabet languages are ignored when performing a search. This alleviates the user

from having to remember the correct diacritical marks for words.

“Ignore diacritical marks” can be disabled by unchecking this option:

Useful Features

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Figure 5-8. Ignore Diacritical Marks

“Ignore diacritical marks” is also disabled for Asian languages.

5.5 VCR BUTTONS

The arrow icons below the search button provide a way to go back or forward

through searches performed.

Figure 5-9. VCR Buttons

For example, clicking on the left < arrow goes back to the previous word or words

searched. The right > arrow moves one search forward within the set of terms

searched.

The outside arrows go to the very first term searched or to the last term searched.

5.6 CLEAR SEARCH

To clear the search results panel and the search field, press the “Clear Search”

button.

Figure 5-10. Clear Search

5.7 CANCEL

To stop a search in progress, press the “Cancel” button

5.8 SMQ ANALYSIS

This function allows user to assess MedDRA coded data against SMQs to identify

“hits” or matches for the purposes of performing analysis. To perform this analysis,

you will first need to select language/MedDRA version, and search type (narrow,

broad, and algorithmic).

Useful Features

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Please see the latest version of the SMQ Introductory Guide for explanations of

narrow, broad, and algorithmic searches.

By default all SMQs are applied in the search, however, individual SMQs may be

selected by pressing and holding down the CTRL key or groups of SMQs may be

selected by holding down the SHIFT key.

Once the language / version, search type have been selected, click “Next” to import

the spreadsheet of MedDRA terms.

Figure 5-11. SMQ Analysis Options

Data must be in a Microsoft Office Excel or compatible spreadsheet with the first row

containing the column headers and with data starting on the second row. Four

columns are required in the following order (Row ID, LLT/PT Term, LLT/PT Code,

Case ID). The Row ID value is optional (note the row ID column is required). Either

the LLT/PT Term or LLT/PT Code must be provided for English language data. For

non-English language data, both LLT/PT Term and the LLT/PT Code must be

provided. The Case ID is optional but must be used if you are performing an

Algorithmic Search against the algorithmic SMQs in MedDRA.

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Figure 5-12. SMQ Analysis Input Data

After generating the report, you can export it to a spreadsheet.

Figure 5-13. SMQ Analysis Report

The report shows which terms in your spreadsheet are in the SMQs that were

selected for analysis. Terms that are not in any of the selected SMQ are labeled

with “No Match”. For Hierarchical SMQs, the hierarchy information is shown in the

right most columns.

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5.9 HIERARCHY ANALYSIS

This function lets you retrieve the MedDRA hierarchy of multiple terms uploaded at one

time and optionally includes the secondary SOC path. To perform this analysis, you must

first select the language and MedDRA version. Then determine if you wish to include

secondary SOC information, the HLGT and HLT hierarchy in your export. If you wish to

exclude this information, simply uncheck these options before continuing. Users may also

opt to include MedDRA codes for all levels of the hierarchy exported.

Figure 5-14. Hierarchy Analysis Options

Next, import the spreadsheet with the desired MedDRA terms. Data must be in a Microsoft

Office Excel or compatible spreadsheet with the first row containing the column headers

and with data starting on the second row. Three columns are required in the following order

(Row ID, Term, Code). The Row ID value is optional (note the row ID column is required).

Either the Term or Code must be provided for English. In non-English data, both Term and

Code must be provided.

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Figure 5-15. Hierarchy Analysis Inputs

After generating the report, you can export it to a spreadsheet for further analysis.

Figure 5-16. Hierarchy Analysis Report

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6. USEFUL FEATURES

6.1 HISTORY FUNCTION

To view basic historical information about a MedDRA term, right click on the term in

either the search results panel or the hierarchy panel and select “Open History.”

Figure 6-1. Open History

A history window will appear showing basic history information for the selected term:

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Figure 6-2. Open History Results

History information is available in each of the supported languages. History

information for non-English languages begins when that language was introduced

(supported) into MedDRA.

6.2 COPY TERM / COPY CODE

To copy a term name or MedDRA code into the computer’s clipboard for pasting in a

document, right click a term in either the search results panel or the hierarchy panel

and select either “Copy Term” to copy the term name, or “Copy Code” to copy the

MedDRA code.

Figure 6-3. Copy Term

The term name or term code can be pasted into another document such as a word

document.

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6.3 OPEN DETAILS AND OCCURRENCES

To view open details and occurrences of a term, right click on the term in either the

search results panel or the hierarchy panel and select “Open Details and

Occurrences.”

Figure 6-4. Open Details & Occurrences

A details and occurrences window will appear showing similar information as shown

in the term details panel on the lower right of the MDB, including term occurrences in

MedDRA hierarchy and placement in SMQs.

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Figure 6-5. Term Details in Primary Language

6.4 RESEARCH BIN

The research bin collects and stores terms during an MDB session for research

purposes.

To add term to the research bin, right click on a term and press “Add to Research Bin.”

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Figure 6-6. Add to Research Bin

Multiple groups of sequential terms can be added to the research bin by selecting

and holding down the shift key and clicking on term names.

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Figure 6-7. Add Multiple Groups to Research Bin

Multiple non-sequential terms can be added to the research bin by holding down the

control key and clicking individual terms.

Individual terms in the research bin may be removed by checking the box in the

“Remove” column and selecting “Remove” at the bottom of the research bin:

Figure 6-8. Remove Terms From Research Bin

The entire research bin contents may be removed by clicking “Clear All.”

A term and some subordinate terms may be added at one time by right clicking on a

term and selecting “Add Selected Levels to Research Bin.”

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Figure 6-9. Add Sub-categories to Research Bin

Then, continue by selecting which levels of the hierarchy need to be added. The

research bin is displayed.

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Figure 6-10. My Research Bin

6.5 EXPORT RESEARCH BIN TO SPREADSHEET

Before exporting the research bin to a spreadsheet, there is an option to label the

research bin. For example, enter a topic name in the “My Topic” field above and click

on “Export.” Then determine if you wish to include secondary SOC information and

the HLGT and HLT levels of the MedDRA headachy. If you do not want to include

this information, unselect these options before exporting.

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Figure 6-11. Research Bin Label

Included in the export spreadsheet are the topic name, if entered, a date/time stamp,

and the term names, levels and SOC hierarchy information.

Figure 6-12. Export Spreadsheet

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6.6 IMPORT A PREVIOUSLY EXPORTED RESEARCH BIN

To import a previously exported research bin, press the “Import” button to find the

spreadsheet on your local computer or local network and select it.

Figure 6-13. Import Previously Exported Spreadsheet

Results:

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Figure 6-14. Imported Terms Results

MDB can only export and import the Research Bin the Microsoft 97-2003 XLS format.

6.7 SMQ EXPORT

To export an SMQ and its related PTs to a spreadsheet, select SMQ view. Right

click on an SMQ and select “Export SMQ.”

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Figure 6-15. SMQ Export

You will be presented with a popup window asking if you want to include inactive

PTs.

Figure 6-16. Include Inactive Terms

Press “Yes” if you wish to include inactive PTs; otherwise click “No” to export the

contents of an SMQ to a spreadsheet. You will be presented with the SMQ Export

spreadsheet.

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Figure 6-17. SMQ Export Spreadsheet

Notice that the contents of the SMQ, including the SMQ name, PTs, and PT scope

are included. The yellow highlighted rows are inactive PTs. Remember inactive PTs

would only be included in an export if you clicked “Yes” in the popup screen to

include them.

Appendix A. MedDRA Desktop Browser Feedback Form

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7. MedDRA/J SPECIFIC FUNCTIONS

While the concept and contents of the Japanese version of MedDRA are exactly

the same for English as they are in all of the other supported languages, there

are some unique features in the Japanese translation of MedDRA due to

language, culture, and medical practice.

To use the Japanese MedDRA features in the MDB, Japanese must be set to the

primary language. Select “SOC View.”

Figure 7-1. Select Language Option

7.1 KANA / KANJI

The Japanese version of MedDRA contains a translation for both Kanji and

Kana. Kanji is the written form of Japanese displayed in the hierarchy view and

term detail information. The Kana translation is used to help the reader of

Japanese know how to pronounce the Kanji term, and is provided for current

LLTs and higher level terms – PT, HLT, etc.

To see the Kana translation of the Kanji terms in the hierarchy panel, click the

“Kana” checkbox in the configuration options panel.

Figure 7-2. Kana Translation Option

Notice that the Kana translation appears to the right of the Kanji translation

separated by a slash.

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Figure 7-3. Kana / Kanji Translation

Additionally, the Kana translation is always displayed in the term details

information found in the term details panel and the “Open details and

Occurrences” right click option.

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Figure 7-4. Open Kana Details & Occurrences

Figure 7-5. Kana Term Details

7.2 J-CURRENCY

In the Japanese translation of MedDRA, there is an additional currency flag for

LLTs to address instances when two or more English LLTs are translated to the

same Japanese term. Japanese MedDRA currency – called J-currency –

ensures the uniqueness of Japanese MedDRA terms by flagging only one of the

duplicated translations for current use.

The MDB supports several methods to identify the J-currency status of LLTs.

When browsing the MedDRA hierarchy at the LLT level, English text to the right of

an LLT separated by parentheses indicates a term that has been set to J non-

current status (Jcurr:N)).

Figure 7-6. J-currency Status

Click on the LLT and refer to the Term detail panel.

Note the J-currency flag is set to “No.” The same information appears in the

Open Details and Occurrences popup.

Right click on the term and select “Open Details and Occurrences.”

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Figure 7-7. Open Details & Occurrences J-currency

To view changes to the J-currency status, right click on the term and select

“Open History.”

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Figure 7-8. Open History _J-currency

Figure 7-9. J-currency History Results

Notice both LLT currency and the J-currency information are indicated.

7.3 MedDRA/J SYNONYMS – THEY ARE DISPLAYED BELOW THE LLT LEVEL

To address some of the linguistic challenges described earlier, the Japanese

Maintenance Organization distributes a Japanese synonym file for each

MedDRA Japanese translation release. This synonym file is different than the

synonym search function explained in the MDB search section, which applies to

English and the other supported languages.

The Japanese Maintenance Organization distributes the synonym file (called

LLT_SYN.asc) one month after the release of MedDRA/J. To install the

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LLT_SYN.asc file, it must be included in the same folder from which MedDRA/J

is loaded into the MDB. If you have installed MedDRA/J before the synonym file

was released you will be required to uninstall MedDRA/J files from the MDB and

reload them with the synonym file included in the folder with the rest of the

MedDRA/J files.

To view the Japanese synonym for an LLT, search for a term.

Figure 7-10. Search for a Term

Right click on the term and select “Go to Browser.”

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Appendix A. MedDRA Desktop Browser Feedback Form

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Figure 7-11. Japanese Term – Go to Browser

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Figure 7-12. Go to Browser Results

The synonyms appear below the LLT level in the hierarchy view:

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Figure 7-13. Results_ J-synonyms

7.4 MedDRA/J LEGEND

In addition to the other color code explanations, the J-currency and Japanese

synonym list identifiers are presented in the legend to help users remember what

these symbols mean. They appear in both SOC and SMQ legends.

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To view the J-currency and Japanese synonym list identifiers, click on “Legends”

at the top of the screen.

APPENDIX A. MedDRA DESKTOP BROWSER FEEDBACK FORM

Purpose

This form provides you with the tool to identify and communicate issues or development

ideas for the MedDRA Desktop Browser to the Maintenance and Support Services

Organization (MSSO). It is divided into two sections. The first section should be used to

identify software “bugs” or errors. The second section should be used to propose

enhancements of existing capabilities or to propose new capabilities. Please use the

correct section for your feedback.

Software Errors

Please use the following format to record any software glitches or errors that you may

have encountered while using the MedDRA Desktop Browser:

Screen or function where glitch/error/“bug” occurred (e.g., screen name):

Description of cause of error:

Result of error:

Attachments to clarify the above (e.g., screen shots, notes):

Proposed Enhancements

Please use the following to submit suggested enhancements to the MedDRA Desktop

Browser:

Capability proposed:

Location(s) available for capability within MedDRA Desktop Browser (e.g., menu item,

short-cut icon):

Attachments (e.g., proposed layout, notes):

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Please e-mail your input to mssohelp@meddra.org. Thank you.