MedDRA

Format Check

Introduction

The Medical Dictionary for Regulatory Activities (MedDRA) is used in clinical trials to code medical terminology, and is used widely in the pharmaceutical industry.  A new version for this dictionary is released every six months, and the version used should be the same within a particular study. 

Purpose

Validates that: 

• MedDRA reference is used in all the files that contain  MedDra medical terminology
• The format MedDRA version is consist through out the study 
• The MedDRA version used is identical across the study
• If an adae.sas7bdat file type of has been uploaded, the MedDRA version is extracted from the ADaM file and utilized for this verification process.

Applicability 

Inclusion conditions 

The applicability is according to predefined keywords. The keyword are defined per company, but typically includes the following:

• system organ class
• SOC
• preferred term
• PT
• MedDRA

Exclusion

• Empty table
• If predefined keywords appear in the table, along with the inclusion condition, the table should be not applicable:

The keyword are defined per company, but typically includes the following:

• • CM
  • adcm
  • concomitant medication

Discrepancies

Type 1 (Consistency + specific Verbatim )

• "MedDRA" is not verbatim. Expected: "<Company phrasing>."
• MedDRA quote is missing
• Different MedDRA version "xxx" compared to the reference file version "xxx"
  Or (If ADAE ADaM file is set as a reference):
• Different MedDRA version "xxx" compared to the ADaM file version "xxx"

Type 2 ( Consistency with phrase to whole the study)

• Different MedDRA reference "<MedDRA in the specific table>" compared to the reference file "<MedDRA reference>"
• MedDRA quote is missing

Discrepancy Example

Reference file

table