MedDRA Coding


I have recently attended a 2-day course in MedDRA basic coding, Safety Data Analysis and Standardised MedDRA Queries. (MedDRA is the Medical Dictionary for Regulatory Activities, this was developed in the late 1990s by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), to facilitate sharing of regulatory information internationally for medical products used by humans).

The workshop was an opportunity to work through scenarios and examples and engage with experts in the Pharmacovigilance field. It was also good to note that there was also a member of staff from the CTU of the MHRA. MedDRA is now the standard dictionary in use to report standard terms when reporting and also analysing safety data. The dictionary helps with the conversion of verbatim terms (when sites complete the adverse event /SAE forms) to terms known as LLTs (Lowest Level Terms) and then to select the unique Preferred Term (PT) for the event in question. The Preferred Term is the unique medical concept and once this is established you can then use the dictionary (which is hierarchical) further to associate the term with a particular SOC (System Organ Class). In this way the data can then be presented in tables in an interpretable form. Although the MedDRA dictionary appears to be straightforward and user-friendly, it is of utmost importance that all those who choose to use it must have the appropriate training and stick with the rules for MedDRA coding.

There is evidence that the Quality of Serious Adverse Events reporting to academic sponsors is far from optimal. (Reference: Sabrina Crépin, Claire Villeneuve and Louis Merle: Pharmacoepidemiology and Drug safety 2016; 25: 719–724). For me the workshop was an opportunity to refresh my knowledge and have hands on experience with a professional trainer who was prepared to work with real scenarios. The big emphasis during the day was the need for staff to query and clean data before it is coded ………. A big reminder that RUBBISH IN equates to RUBBISH OUT. …… yes that was the message of the day.

MedDRA coding is compulsory for CTIMPs and nice to use for all other trials.