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.
Copyright 2015 International Federation of Pharmaceutical Manufacturers and
Associations. All Rights Reserved.
Table of Contents
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Table of Contents
1. INTRODUCTION ......................................................................................... 1
MedDRA Desktop Browser 4.1 .................................................................... 2
2. INSTALLATION OF THE MEDDRA DESKTOP BROWSER ...................... 1
2.1 SYSTEM REQUIREMENTS ........................................................... 1
2.2 uninstalling previous MedDRA Desktop Browser ............................ 1
2.3 access and install the MDB ............................................................. 1
2.4 Loading MedDRA files into the MDB ............................................... 3
2.5 Setting Language Interface Version Preferences ............................ 4
2.6 Removing Files ............................................................................... 7
2.7 Adjusting the Interface .................................................................... 7
3. MEDDRA DESKTOP BROWSER SCREEN ............................................... 1
3.1 MDB Configuration Options ............................................................ 2
4. SEARCHING ............................................................................................... 4
4.1 Search results panel features ......................................................... 7
4.2 Go to browser.................................................................................. 7
4.3 Search by code ............................................................................... 8
4.4 Select SOCs to search .................................................................... 9
4.5 SMQ search .................................................................................. 10
5. ADDITIONAL SEARCH FEATURES ........................................................ 13
5.1 Export search results .................................................................... 13
5.2 Search in multiple languages ........................................................ 14
5.3 Synonym list .................................................................................. 17
5.4 Ignore diacritical marks ................................................................. 18
5.5 VCR buttons .................................................................................. 19
5.6 Clear search .................................................................................. 19
5.7 Cancel ........................................................................................... 19
5.8 SMQ Analysis................................................................................ 19
5.9 Hierarchy Analysis ........................................................................ 22
6. 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
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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Appendix A. MedDRA Desktop Browser Feedback Form
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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.
