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