Medical coding in clinical trials - The IT physician's Page Page 1 of 3

MEDICAL CODING - Clinical trials

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MedDRA 12.1 MedDRA 12.0

LLT 67503 66135
PT 18641 18075
HLT 1699 1688
HLGT 333 332
SOC 26 26

Medical coding : (or Term Harmonization) Different Trial Sites, Different culture and Time-zones, Different investigators
(physicians) and various other factors leads to variations in the Research Data entered in particular fields. Few of these data like
Adverse event and Disease History is essentially entered as free text and thus coding is an essential method to harmonize all
these data so that it is analysed properly. The data entered is compared and matched with standard libraries or dictionaries and
updated with a data which is uniform and acceptable. Coding may be done automatically (Computer Aided) , manually or a
combination of both.

This medical coding is different : If you search for "medical coding" on web , you will be driven to websites which deals with the
ICD or CPT medical coding which is different from the coding in clinical trials. The ICD (9,10 etc.) medical coding deals with
mapping various medical diagnosis and procedures to codes. This mostly deals with medical insurance data and medical billing.
The ICD or CPT coding is out of scope here in this tutorial.

Dictionaries are essential for medical coding. These medical dictionaries contains standardized database with which the verbatim
terms entered in the CRF's is matched. Few Clinical research organizations even keep their own customized dictionary e.g. Drug
dictionary .

Various Medical Dictionaries / Thesaurus :

Dictionary / Thesaurus
Full name Primary Use
name
WHOART World Health Organization Adverse Reaction Terminology Adverse event (AE) coding
(FDA’s) Coding Symbols for a Thesaurus of Adverse Reaction
COSTART Adverse event (AE) coding
Terms
Medical Dictionary for Regulatory Activities Terminology
MedDRA AE / Med. History / Terms coding
(latest V 12.0)
International Classification of Diseases (9th / 10th Revision / Medical diagnosis and procedures
ICD (9, 10, 10 CM etc.)
10th revision - Clinical Modification) coding
WHODD World Health Organization Drug Dictionary (B1, B2, C) Medication coding (concomitant)

These Dictionaries follow a hierarchal structure for coding. Dictionaries are always under constant up-gradation and comes with a
newer version frequently.

In what form is it available ? : Consider the case of MedDRA where Dictionary is supplied as bunch of flat ASCII files ($
character separated) with proper documentation and defined data types, so that any standard databases can easily import the file
e.g. Create a Oracle template (DBT) using the MedDRA documentation and import the dictionary.

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MedDRA browser is available as a download from MSSO Website, for those who need to do manual coding. The
MedRA ASCII files can be imported to the local computer and used. Automatic coding systems however requires these ASCII
data files to be imported to some RDBMS like Oracle, MySQL, PostGRE SQL or as SAS Datasets.

Example > MedDRA table structure SQL >>>

WHO-DD is similarly distributed as ASCII files as well. WHODD browser is also available with comes with a fat price Tag.

Automatic coding (auto-coding) : The complexity of medical science makes autocoding a failure. The "text (verbatim)" terms
entered into the system is matched with the terms found in the dictionaries. Autocoders are efficient with "exact" or '100%'
matches for the verbatim term and miss-spellings will lead to erroneous or no result. . Its not a good idea to rely on autocoding
entirely (especially when dealing with medical terms) and the results of Higher level terms sometimes turns out to be funny.
Autocoders get confused if two terms are reported simultaneously e.g. fever and rash or fever & rash ; this kind of data entry can't
be avoided because clinicians are used to such kind of data recordings.
Mostly the autocoders follow fixed and limited algorithms for the medical coding (algorithms are programmed by
Software professionals who doesn't care about the essence of Medicine and hence such algorithms turns out to be waste) . The
typical algorithms include text replacements (e.g mild raised temp. and low grade fever is transformed to mild fever) , text
removal (e.g. low fever changed to fever), numeral removal (e.g. fever-104 replaced with fever).
A combination of auto and manual coding always works for fast and better results.

Example 2:
Example :
Medra terms: (details later in this page) Toothache (LLT)
Back pain (LLT)
LLT : Lower level terms Toothache (PT)
Back Pain (PT)
HLT : Higher level terms Dental pian and sensation disorders
Musculoskeletal and con. tissue signs and symptoms NEC
HLGT : Higher level group term (HLT)
(HLT)
SCT : Super class term Dental and Gingival conditions (HLGT)
Musculoskeleteal and connective tissue disorders NEC
SOC : System organ class Gastrointerstinal Disorders (SOC)
(HLGT)
Musculoskeletal and connective tissue disorders (SOC)

COSTART terms: (details later in this page)

RT :Reported Term
ET :English Term
SBS :Sub-Body System
PBS :Primary Body System

WHODD: WHODD is available in now available in 2 formats - B and C. Previously format. A was available which is now
obsolete. C is the current format and is been in place since last 4-5 years; it contains more information than B format. B is still in
place as the older set ups find it difficult to migrate to C yet. For coding of the therapeutic use of drugs, Anatomical Therapeutic
Chemical classification (ATC) is used. Each drug is assigned at least one ATC code. ATC - Anatomical-Therapeutic Chemical
Classification that is the parts and systems of the human body where the drug might have an effect.

WHO Dictionaries :
1. WHODD : WHO Drug Dictionary
2. WHOHD : WHO Herbal Dictionary
3. WHODDE : WHO Drug Dictionary enhanced

ATC codes : The classification categorises substances at five different levels according to the organ or system on which they act
and their chemical, pharmacological and therapeutic properties. There are fourteen main groups (1st level), with one
pharmacological/therapeutic subgroup (2nd level). The 3rd and 4th levels are chemical/pharmacological/therapeutic subgroups
and the 5th level represents the chemical substance

Anatomical Therapeutic Chemical groups - first level

A Alimentary tract and metabolism
B Blood and blood forming organs
C Cardiovascular system
D Dermatologicals
G Genito urinary system and sex hormones
H Systemic hormonal preparations, excl. sex hormones and insulins
J Anti-infectives for systemic use
L Antineoplastic and immunomodulating agents
M Musculo-skeletal system
N Nervous system
P Antiparasitic products, insecticides and repellents
R Respiratory system
S Sensory organs

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V Various

Level Code Content

1 J ANTIINFECTIVES FOR SYSTEMIC USE Anatomical
main group
2 J01 ANTIBACTERIALS FOR SYSTEMIC USE Therapeutic
subgroup
3 J01F MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS Pharmacological
subgroup
4 J01FA MACROLIDES Chemical
subgroup
5 J01FA06 ROXITHROMYCIN Chemical
substance

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