Wednesday, June 18, 2008

Saturday, June 14, 2008

Verbatim Terms and Medical Dictionaries


"These are answers that are recorded word by word (from a subject)" and are often used as a backup of research findings in the final report. These verbatim terms entered in the CRF's are then matched with the "standardized medical dictionaries", which are essential for medical coding. A little more on use of Dictionary is given below:
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Dictionary name and its Use

WHOART: World Health Organization Adverse Reaction Terminology:

is used for Adverse event (AE) coding

COSTART: (FDA’s) Coding Symbols for a Thesaurus of Adverse Reaction Terms:

is used for Adverse event (AE) coding

MedDRA: Medical Dictionary for Regulatory Activities Terminology:

is used for AE / Med. History / Terms coding

ICD9CM: International Classification of Diseases 9th Revision Clinical Modification:

is used for Medical History coding

WHODD: World Health Organization Drug Dictionary (B1, B2, C):

is used for Medication coding (concomitant)

The WHO Dictionaries include:

  • WHODD : WHO Drug Dictionary
  • WHOHD : WHO Herbal Dictionary
  • WHODDE : WHO Drug Dictionary enhanced.

*ATC: Anatomical Therapeutic Chemical classification is a classification used for coding the therapeutic use of drugs. This classification categorizes substances at five different levels according to the system or organ they act on and according to the chemical, therapeutic & pharmacological properties.

More:
http://www.riteshmandal.com/medcoding.htm

Friday, June 13, 2008

"AETERM is Verbatim Name" and "AEDECOD is Preferred Term"


While doing AE Listings, there exists some confusion as these words (AETERM & Preferred TERM) sound similar. Every time I annotate AE Listing, I map “–TERM Variable for Preferred Term” and “–DECOD Variable for Verbatim Name” which is exclusively wrong. I have posted it here just to remind myself "AETERM (i.e., reported term) is Verbatim Name" and "AEDECOD is Preferred Term". Listed below is the CDISC Guidelines for Variables:

Define Variables and CDISC Guidelines:

System Organ Class (SOC) / --BODSYS:
It is the Body System or preferred system organ class that is involved in an event or measurement from the standard hierarchy.

Preferred Term (PT) / --DECOD:
It is the Dictionary derived text description of the topic variable. Equivalent to the Preferred Term (PT in MedDRA). The dictionary name and version should be provided in the comments column in the data definition file.

--TERM:
It is the Topic variable for an event observation, which is the Verbatim Name of the event. Use --MODIFY for modifying the verbatim term and --DECOD for coding --MODIFY or --TERM.

--MODIFY:
It is the Modified Text, if the topic variable is modified as part of a defined procedure.

An Eg. of MedDRA Hierarchy

System Organ Class (SOC) : Gastrointerstinal Disorders

High Level Group Term (HLGT): Dental and Gingival conditions

High Level Term (HLT): Dental pian and sensation disorders

Preferred Term (PT): Toothache <=SSC or SMQ

Lowest Level Term (LLT): Toothache

Must Read For SAS Clinical Programmers!


http://www.cdisc.org/pdf/V3CRTStandardV1_2.pdf

It is an informative pdf on "CDISC Submission Data Domain Models"