MedDRA and WHODrug Coding

Though there are other Coding dictionaries available along with MedDRA (ex: COSTART and WHOART), MedDRA dictionary is typically used in the US for Adverse Events coding.

AE\MedDRA coding is not the SAS programmers work; it is usually done by medical coder or database programmer. Coding basically involves a process of finding a dictionary term that matches the verbatim term reported on the CRF, and getting the other related dictionary derived variables useful for the analysis like System Organ Class (SOC), Preferred Term (PT) and Lowest Level Term (LLT), etc.

Some times this process may take more time than expected, because Misspellings and other differences would delay the process of coding. In that case, person responsible for coding has to look for the dictionary term that which is the best possible match from the MedDRA dictionary.

So the question here comes is what SAS programmer can do in this process.

Here is the Answer….

SAS programmer has to work hard to make this process successful. In other words he is also a key player in this game.

SAS Programmer provides a list of reported AE terms on the CRF to the medical coder in a flat file/excel file, who then search for a best possible match and related terms for AE term of CRF in the MedDRA dictionary. He then enters them in the supplied flat/excel file and returns back to the SAS programmer.

The next SAS programmer duty is to assign the Dictionary derived Term, SOC, LLT and PT to the AE Terms in the AE dataset by merging. (Use Proc SQL or Simple Merge)

MedDRA dictionary gets updated twice a year, so it is important to be aware of the version used for the coding.

If the data is clean (Assuming that there are no misspelling of AE terms or other problems then MedDRA coding is easy…. What you have to do is locate the MedDRA SAS dataset and then merge the MedDRA dataset with the AE dataset using the preferred term.

Medical Dictionary for Regulatory Activities (MedDRA):

MedDRA an Introduction:

Recommendations for MedDRA® Implementation and Versioning for Clinical Trials

Applying MedDRA® in Clinical Safety and Pharmacovigilance

WHODrug Dictionary Coding: