The Medical Dictionary for Regulatory Activities ("MedDRA") is a complex medical terminology that is used globally to code and analyze clinical and post-marketing adverse drug reactions for regulatory purposes.  Learning how to use MedDRA effectively is a multi-step process:

  • Understanding basic MedDRA concepts and structures
  • Gaining access to the  database
  • Learning to use the appropriate software tools

The MedDRA dictionary contains approximately 85,000 terms representing unique medical concepts.  It is far too large for a person to work directly with the raw data.  Sophisticated software applications are needed to store, search, and apply dictionary terms to various regulatory tasks that must be accomplished.  MTools from Terminologix is one such tool, which offers a level of performance and ease-of-use that is unsurpassed.

Understanding MedDRA

Your best source for learning about MedDRA and its complexities is the MedDRA Maintenance and Support Services Organization (MSSO).  The MSSO is charged with updating and maintaining the terminology database and providing tools and training for MedDRA users.  Visit their site at meddra.org for introductory and advanced training on fundamental concepts and best practices for using MedDRA.

Gaining Access to MedDRA

It requires tremendous effort to continually update a complex medical terminology and all its translations.  The cost of that effort is paid for by MedDRA users through annual subscription fees.  You will need to acquire a subscription from the MSSO before you can access the raw MedDRA data or any software applications containing that data (including MTools).  Once you have paid for your subscription, the MSSO will provide you with a MedDRA Id and password, which are your keys to accessing terminology data and tools.

Selecting and Using MedDRA Tools

Large pharmaceutical, biotechnology and medical device companies may have their own commercial or custom adverse event systems through which they access MedDRA.  Their IT staffs take care of downloading terminology data files, storing them in their local databases, and configuring the tools to use the appropriate version of MedDRA.  In-house training is often available to learn how to use those tools.

Smaller companies, universities and researchers may not have such resources and need free or low-cost tools that help them use MedDRA effectively.  Currently, the only free tools are the ones provided by the MSSO and our cloud-based MedDRA toolset called “MTools”.  The MSSO tools do an adequate job of meeting basic needs for using the terminology.  MTools, on the other hand, is a high-performance, online toolset using the latest technologies to optimize coding and analysis with MedDRA.

MTools is free for MedDRA subscribers so please try it.  Watch our introductory video below or go the clinical or technical page to get more details about how to use MTools.

 

Walk-through Video

Advantages Of MTools

  • Integrated toolset

  • High performance

  • Ease of use

  • Global scalability

  • Natural language searching

  • High-speed case series analysis

  • Browser-based

  • Sophisticated applications

  • An API for custom scripts/programs

TRY IT

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With MTools, we don’t believe it has to be difficult to learn how to use MedDRA simply because of the ease-of-use with our program. Again, MTools is free to use and easy to try out if you already have a MedDRA subscription. Give it a try and let us know what we can do to improve. We have come a long way in the development but we are not done.  We are always looking to innovate and make improvements based on your feedback.