Many organisations have implemented MedDRA and have provided lessons learned about key areas of focus. While there is no single approach appropriate for all organisations, the following topics are provided as common areas to be considered when implementing MedDRA.
- Training – A recommended first step in implementing MedDRA is to get a core group of personnel trained in MedDRA. The MSSO provides free training (face-to-face, webinars, and videocasts) on basic and advanced MedDRA topics.
- Coding and Data Retrieval Conventions – MedDRA was designed for sharing safety information for human medical products. However, unless users achieve consistency in how they assign terms to verbatim reports of symptoms, signs, diseases, etc., and in methods for data retrieval and evaluation, the use of MedDRA cannot have the desired harmonising effect in the exchange of coded data. There are two ICH-endorsed Points to Consider documents which are designed to promote the accurate and consistent use of MedDRA. They are updated with each MedDRA release and are companion documents for MedDRA.
- Procedure Documentation – Documentation of procedures and processes is a best practice for all organisations, and this applies to MedDRA. Standard operating procedures and other relevant documents in an organisation should address the use of MedDRA including coding, dictionary management, MedDRA versioning, and analytical processes and tools (e.g., using MedDRA’s hierarchy and Standardised MedDRA Queries [SMQs]).
- Legacy Data Conversion – If an organisation has data in a different terminology that may need to be converted to MedDRA, there are several options to consider. Conversions can be made from the original reported verbatim terms (if available) or from the coded terms of the legacy terminology to MedDRA. The WHO Uppsala Monitoring Centre and the MSSO maintain a WHO-ART to MedDRA bridge to support the conversion of WHO-ART coded data to MedDRA.
- IT Considerations – There are many software tools available to support the use of MedDRA. Several of them are provided free with the MedDRA subscription. This includes two browsers (desktop and web-based) that are useful for staff training, term selection, and analysis purposes. The MSSO provides a MedDRA Versioning Tool (MVAT) that identifies the differences between any two MedDRA versions. The need for software tools may be driven by the volume of data to be supported. With small amounts of data users can use simple software tools (e.g., free MSSO browser, spreadsheets) but larger implementations should consider commercial software products that support coding, data management, and electronic reporting.