WHOdrug

Format Check

Introduction

The WHODrug Dictionary is an international classification of medicines, created by the WHO Programme for International Drug Monitoring. It is used by pharmaceutical companies, clinical trial organizations, and drug regulatory authorities for identifying drug names in clinical trials.

Purpose

Validates that:  

• WHOdrug reference is used in all the relevant files 
• The WHODrug version is written according to the company format.
• The WHOdrug version used is identical across the study.
• If an adcm.sas7bdat file type of has been uploaded, the WHOdrug version is extracted from ADaM file and utilized for this verification process.

Applicability 

Inclusion conditions 

• Tables with source data contains ‘adcm’
• ADaM

Exclusion 

• Empty table
• Figure, Listing, LoT, Mock Shell

Discrepancies

• Different WHOdrug version vxxx compared to the ADaM file version vxxx.
• WHOdrug reference is missing
• Enhanced dictionary is not permitted
• WHOdrug reference is not verbatim. Expected: WHODDG B3 vxxxxxx coding dictionary applied

Discrepancy Example
Image 1: WHOdrug discrepancy in a table: the WHOdrug version is different from the reference shown in Image 2.

       Image2 : Reference version for the WHOdrug version.