1. CODING MANAGEMENT
(Part II)

2. Recap Coding What are Coding Dictionaries Structure of Dictionaries
Different Forms of Coding
How Organizations Handle Coding?
Challenges
Dictionary Types
Process of Coding

3. Dictionary Types
COSTART --Coding Symbols for a Thesaurus of Adverse Reaction Terms
MedDRA--Medical Dictionary for Regulatory Activities
WHODRL -- World Health OrganizationDrug Reference List
WHOART-- World Health Organization Adverse Reactions Terminology
ICD-9-CM-- International Classification
of Diseases, Ninth Revision, Clinical Modification

4. What Does The Future Hold For Dictionaries?
MedDRA
Medical Dictionary for Regulatory Activities
Replaces WHO-ART, ICD-CM, CoSTART
WHO Drug
Replaces BNF dictionary

5. What Does The Future Hold For Dictionaries?
What is the impact of MedDRA and WHO-Drug?
No misspelled verbatim terms
Industry standards
Outside governance w/ periodic updates

6. - Subject Drug Indications Non Drug Treatment WHO - ART
ICD-9-CM
____________________
International
Classification of
Diseases - 9th Edition
Clinically Modified
________________
- Cause of Death
- Medical History
- Concomitant Illness
- Primary Diagnosis
- Secondary Diagnosis
- Subject Drug Indications
Non Drug Treatment
WHO - ART
_____________________
World Health
Organization -
Adverse Reaction
Terminology
____________
- Adverse Events
Serious
Non-Serious
-Maps to COSTART for
reporting purposes
BNF
___________________
British
National
Formulary
_______________
- Study Drugs
- Concomitant Drugs
Previous Drugs

7. A Sample of Encoding level terms from this category shows:
M = Terms accepted as misspellings
Q = Terms that no longer encode
Terms that no longer encode (Q’d terms) are terms that were acceptable at
one time, but due to convention changes are no longer acceptable. Or they can be
terms which were accepted in error and need to be “shut off”.

9. Head discomfort
Central & Periph. Nerv.
Headache
Head pain
Head pressure

10. How Does The Dictionary Process work?
Autoencoding
Once data from the case report form has been entered and verified, the Data Manager begins an electronic autoencoding process which compares the text of the investigator term in the clinical trial database to the text strings stored in the dictionary databases. When an exact match occurs, the code from the term in the dictionary database is automatically entered into the clinical trial database. The term is considered “autoencoded”.

11. What Happens When A Term Doesn’t Autoencode?
Three potential dispensations can be assigned:
Accepted: the term is added to the central dictionaries and will be available for autoencoding the next time that exact term exists in a database.
Accepted as a Misspelled Term: the term is added to the central dictionaries with a flag of “M” indicating it is an unambiguous misspelled term. These terms will autoencode.
Rejected: as is, term cannot be accepted into the central dictionaries. More information is needed.

12. Query Writing
Respell – Please correct the spelling of _ to _. Thank you.
Clarify as follows_. If reporting _ then please edit or provide a ref/copy of the label. Thank you. (QC:Ref…)
Clarify as follows _. Are you reporting _? Or _? Or other? If so then please edit or provide a ref / copy of the label. Thank you.(QC: Ref ….)
Clarify as follows_. Can’t find. Please edit to include accurate trade / ingredient name or provide a ref / copy of the label. Thank you.(QC: Ref ….)

13. Query Writing
Clarify as follows_. Multiple formulations available. Are you reporting…. Clarify as follows_. Please spell out the abbreviation XYZ . Thank you. (QC: Ref….) Clarify as follows_. Please edit out symbols/characters from the term and edit as_. Thank you. Multiple concepts for _. Please split the term ___ into ___ and ___. Thank you

14. WHO Drug Conventions
Abbreviations - In general, abbreviations must be completely unambiguous to be coded. If a verbatim term consists only of an abbreviation, the abbreviation is acceptable only if it has one interpretation.
Misspelled & References to Age/Dates/Years – Not Accepted.
Foreign Drug spelling are accepted in Who Drug
Symbols – ® , * , $, -- Not Accepted (*context)

15. WHO Drug Conventions
Drug vs. Non Drug - A Drug is swallowed, injected, infused, inhaled, inserted, applied, chewed,A Non Drug is procedures, non-drug treatment, or devices, Radiotherapy. However, if a drug is named along with a procedure, then code to the drug named Wound dressing/Bandage + Drug = Drug Wound dressing/Bandage - Drug = ALL OTHER NON- THERAPEUTIC PRODUCTS (promote healing through absorption) Wound Dressing/Bandage(support, pressure, compression) = non-drug treatment

16. Generic/Generic—Non-synonyms
1) Verbatim term: “Hydrochlorothiazide and triamterene”
Coding decision: HYDROCHLOROTHIAZIDE/TRIAMTERENE
2) Verbatim term:“Naproxen and misoprostol”
Coding decision: Napratec
3) Verbatim term:“Codeine and phenytoin”
Coding decision:Split the term (There is not a multi-ingredient entry for this verbatim term and the term cannot be referenced as a marketed combination.)
Generic/Generic----Synonyms
1) Verbatim term: “Paracetamol/Acetaminophen”
Coding decision: PARACETAMOL

17. Trade/Generic----Synonyms 1) Verbatim term: “Cephalexin—Keflex” Coding decision: KEFLEX Trade/Generic----Non-synonyms 1) Verbatim term: “Advil - Metronidazole” Coding decision: Split Trade/Trade----Non-synonyms 1) Verbatim term: “Advil/Tylenol” Coding decision:Split the term Trade/Trade---synonyms 1) Verbatim term:“Datril/Tylenol” Coding decision:Split the term

18. MedDRA browser
Instructor note: These slides have been up-versioned for MedDRA v These slides have not been modified to reflect CoDER v. 2.3 browser enhancements.
As long as you have a computer room, you’ll want to demonstrate the CoDER browser. The screen shots and examples used in the training were to highlight features of the tool. The examples captured do not follow through on a specific SOC.
You may choose to follow through on a specific SOC.
The version of the slide-set corresponds to the version (v1.2) of the CoDER MedDRA Browser.

19. Introduction to MedDRA
System Organ Class (SOC) Organization

20. The MedDRA Browser

21. A: Quick Search query area
Contains the fields for performing a Quick Search - This will be covered in the slides on Searching.
B: Radio buttons (NOTE: this functionality will not be available in the initial release of the CoDER MedDRA Browser) The initial release defaults will be:
Vertical Hierarchy (labelled D) shows the primary path only. Terms with more than one path will have a number greater than 1 displayed in the #SOC field.
Horizontal Hierarchy shows all paths.
C: Menu Options
Homepage – Displays the CoDER homepage.
MedDRA – Disabled whilst the CoDER MedDRA Browser is active. When the WHO-Drug Browser is active, clicking on this option will display the CoDER MedDRA Browser.
WHO-Drug – Disabled whilst the CoDER WHO-Drug Browser is active. When the CoDER MedDRA Browser is active, clicking on this option will display the CoDER WHO-Drug Browser.
Adv. Search – Advanced search functionality (available in a future release).
Preferences – Options for setting display and search preferences for the CoDER MedDRA and WHO-Drug browsers (available in a future release).
Help – Displays a window summarizing the CoDER MedDRA Browser functionality.
D: Vertical Hierarchy browsing area
The CoDER MedDRA Browser operates 2 modes of browsing:
Vertical Hierarchy mode – Browsing in this mode is performed in the main part of the CoDER MedDRA Browser labelled as ‘D’.
Horizontal Hierarchy mode – Browsing in this mode is available via a pop-up window, that can be accessed from the Vertical Hierarchy mode by clicking on the two-way horizontal arrow against a term (this will be covered in later slides).
Term Level Details – Source data for an individual term may be displayed in a pop-up window, by clicking on the folder icon against a term.
Fields in the Vertical Hierarchy browsing area:-
Level – Indicates one of the levels of the MedDRA dictionary hierarchy to which the displayed MedDRA term belongs:
SOC – System Organ Class, HLGT – Higher Level Group Term, HLT – Higher Level Term, PT – Preferred Term, LLT – Lower Level Term
NOTE: Verbatim Term Assignments are also displayed, below the LLT level, indicated by VTB for verbatim term assignments approved for global autoencoding, and VTC for verbatim term assignments unapproved for global autoencoding.
NOTE: Lower Level Terms in the vendor MedDRA dictionary that are non-current will have ‘LLT’ displayed with an ‘NC’ subscript in the Level column.
Term – This refers to the actual MedDRA dictionary term.
Code – The unique MedDRA dictionary code assigned to the MedDRA term.
#SOC – Displays the number of SOC paths associated with the term. Terms with multiple SOC paths will have a number greater than 1 appear in the #SOC field. Note that multiple SOCs will only be associated with terms at the HLGT, HLT, and PT level.

22. Vertical & Horizontal Hierarchy Mode – Display Features
Includes 16,559 PT
“Repeats”*
Preferred Term (PT) ,559
System Organ Class (SOC)
High Level Term (HLT) ,681
High Level Group Term (HLGT)
Verbatim Term (VT) / (VTB)
Lower Level Term (LLT) / (LLTNC)
61,704*
MedDRA Hierarchy
V 8.0
No of concepts
(Terms)

23. Vertical Hierarchy Mode -Horizontal Display Term Level Details

24. Horizontal Hierarchy Mode – Display Features
EXAMPLE: LLT SWELLING OF FEET

25. Searching Quick Search Search Results may be saved to Microsoft EXCEL
Advanced Search
The Quick Search function will perform basic searches of the dictionary.
Search Results retrieved from a Quick Search may be displayed in Microsoft Excel and saved.
In future releases of the CoDER MedDRA Browser, more advanced search functionality is available in the Advanced Search option e.g.
Restrict search to specific parts of the hierarchy
Multiple search types for a single search
Save search criteria

26. Search Types Quick Search Types:- Equal Equal/Contains Contains/AND
Contains/OR
Contains/Similar
Wild
Click on the Quick Search Search type drop-down button to display the list of search type options.
Use of Search Types:
Equal – Used for a search on Term or Code: Exact search for the specified MedDRA term or MedDRA Code.
This search is useful in cases where the MedDRA term or code is known, but the user wishes to browse the term hierarchy e.g. Localised Oedema
Equal/Contains – Term Search: Dictionary term equal to or containing the specified search term.
Used when the user wishes to see all terms either matching or containing the specified text e.g. diabetes
Contains/AND – Term Search: Finds dictionary terms containing all of the specified search words in any position e.g. anaemia deficiency
Contains/OR – Term Search: Retrieves MedDRA terms with any of the specified criteria e.g. cardiac heart
Contains/Similar – Term Search: Finds all dictionary terms with a similar spelling.
Useful in cases where the reported term may potentially have been misspelled e.g. anaemia
Stem Search – Term Search: Will search for words that have the entered word as the root.
Useful for retrieving different forms of the same word e.g. ‘burn’ retrieves terms containing, burn, burns, burning, burned etc.
A not B not C not… - Term Search: Will search for dictionary terms that contain the first word, and none of the subsequent words specified.
Used to narrow down the search results, and exclude extraneous terms. e.g. conjunctivitis acute chronic
Wild – Term or Code Search: Enter either a partial word, or a partial code. Also, enter the wildcard character ‘%’ to either side or both sides of the entered search criteria. Wildcard characters may also appear anywhere in the middle of search criteria:
XYZ% - search for all terms/codes beginning with XYZ e.g chronic%
%XYZ – search for all terms/codes ending in XYZ e.g. %deficiency
%XYZ% - search for all terms/codes containing XYZ in any position e.g. %injury%
X%Y%Z – search for all terms/codes that start with X, contain Y, and end in Z e.g. a%immun%syndrome
This search type is used for more general browsing of the dictionary, especially in cases where the specific terminology is unknown.
Sound – Term Search: Finds all dictionary terms that sound like the entered search criteria.
This type of search is useful in cases where the reported term may have been misspelled, as all similar phonetic terms are retrieved e.g. edema

27. Quick Search Example Retrieves No Results
Enter diabete in the Term field
Select the Equal Search Type
Click on Quick Search
Search retrieves no results
A message is displayed in the MedDRA Search Results window
This slide illustrates the MedDRA Search Results window that is displayed when no search results are retrieved after a Quick Search has been performed.
The MedDRA Search Results window displays the search type, and the entered search criteria that was used in the Quick Search.
In our example, the error message in the MedDRA Search Results window indicates that no matching term EQUAL to DIABETE was found in the dictionary.

28. Quick Search Example Retrieves Results
Enter typhoid fever in the Quick Search Term field
Select the Equal Search Type
Click on Quick Search button
The results are displayed in the MedDRA Search Results pop-up window
Now show a Quick Search where search results are retrieved, using the instructions in the slide.
The next slide shows the search results.

29. MedDRA Search Results Window
All terms retrieved from a Quick Search are displayed in the MedDRA Search Results window.
The window also shows the following:
Search Level – the parts of the dictionary knowledge base searched (defaults to ALL LEVELS)
Search Code – the entered search criteria
Search Type – the selected Search Type
Sort Order – the sort order of the retrieved results (defaults to Term)
Button options:
For each of the listed terms, the user may click on the adjoining two-way horizontal arrow to display the term in horizontal hierarchy display mode. The user may then choose to browse the selected term.
Click on the Save To Excel button to display the search results in Excel. (See next slide)
Close – closes the MedDRA Search Results window
View Horizontal Hierarchy of term
Search results may be saved to Microsoft Excel

30. Search Results Displayed In Excel
The slide shows the Search results displayed in Microsoft Excel.
Search results may be saved in EXCEL as follows:-
On the Microsoft Excel menu options,
Click on File, Save As
Select the Save in drive (i.e.the drive where you wish to save the Excel workbook)
Enter a File name
Select Save as type Microsoft Excel Workbook
Click on Save
The search results will be saved as a Microsoft Excel Workbook in the specified file drive.
To Save Search Results in EXCEL:
Click on File, Save As
Select the Save in drive
Enter a File name
Select Save as type Microsoft Excel Workbook
Click on Save