Medical Coding

發布時間:2018-09-28 文章來源:Medical Coding

1、Define Coding – What? & Why?

●Process of converting verbatim terms (text as written on CRF) to a standard terminology.

Verbatim term refers to the clinical data reported by an Investigator on the Case Report Form.

Standard terminology refers to the term that we choose from a coding dictionary.

●What data that are to be coded?

Concomitant Medication

Adverse Events

Medical History

Concomitant Indications

etc.

Why?

●Facilitate accurate and efficient retrieval for medically meaningful review, summation and analysis.

●Reduce the variety of medical text data in the database.

●Automatic classification of medical text data for summary in tables.

●Clear medical text data in the database.

●Increasing harmonization of safety reporting regulations globally; Textual data recorded on a Case Report Form (CRF) is not in an analyzable format.

●Highly regulated environment with strong emphasis on safety surveillance and data quality.

2、Coding Methods

●There are two methods of coding namely:

Auto coding (also known as Automatic coding)

Manual coding (also known as Interactive coding)

3、Coding Tools

● Medidata Coder (RAVE)

● Central Coding (InForm)

●DsNavigator

● OC-TMS

●IBM CD (eCOS) Coding module

4、Coding Dictionaries

●Introduction

A coding dictionary is a standardized tool containing standard terms for coding as per regulatory requirements.

●Commonly Used Coding Dictionaries

WHOART - World Health Organization Adverse Reaction Terminology

COSTART - FDA’s Coding Symbols for a Thesaurus of Adverse Reaction Terms

MedDRA - Medical Dictionary for Regulatory Activities Terminology

ICD10CM - International Classification of Diseases 10th Revision Clinical Modification

WHODD-World Health Organization Drug Dictionary

● MedDRA

MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The activities of the MedDRA Maintenance and Support Services Organization (MSSO) are overseen by an ICH MedDRA Management Board, which is composed of the six ICH parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, Health Canada, and the WHO (as Observer).

●WHO Drug Dictionary

目前WHO Drug只在線上英文編碼,沒有像MedDRA一樣可以線下操作且支持多個國家語言。登錄界面如下:

詞典有3種類型,有B2/C,B3/C3格式,隨著版本不斷更新完善,個別格式不再被延用。如下:

 WHO Drug檢索界面

WHO Drug藥物編碼的選擇依據ATC,ATC是指什么呢?

ATC - Anatomical Therapeutic Chemical Classification

Anatomical is the organ or system on which a drug acts.

Therapeutic (and Pharmacological) is Indication for typical use(s)

Chemical is the Compound structure and properties.

ATC SYSTEM MAIN GROUPS


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