Ten Things to Know About MedDra Coding
When it comes to clinical research and trials, MedDRA is a critical component to creating reporting for the results of research. There is much to learn about this coding system, which is used to share regulatory information about a host of medical products. Here are ten things you should know about MedDRA coding. While initially used mostly by Europe, Japan, and the US, today the use of MedDRA coding has spread throughout the world. Training materials for this type of coding is available in several languages, including Spanish, French, Chinese, Japanese, Hungarian, Dutch, and German. The language of MedDRA coding is designed specifically to allow information about medical products to be shared internationally without concern for language barriers. This allows for easy understanding without requiring foreign language translation services. Breaking the language barrier
misinterpretations. Currently, MedDRA coding is used for pharmaceuticals, medicinal devices, and vaccines. Users of this type of coding can use this handy tool for reporting and documentation of each product's usage. Europe and Japan mandate the use of MedDRA coding for all safety reporting on medical products, allowing for ease of communication in documentation. While not required, it is also widely used throughout the US. MedDRA terms are organized into several classifications, including Preferred Terms (PT), Lower Level Terms (LLT), High Level Group Terms (HLGT), and High Level Terms (HLT). This system is referred to as the System Organ Class (SOC). Terms can be occasionally added to the MedDRA dictionary, but they must be reviewed and approved by international medical officers who make the final determinations. In some cases, existing terminology may be changed after a decision is made by the officers.
The MedDRA coding system is updated twice every year, in March and in September. The second version released every year typically only includes some updates for lower level classifications, though this is not always the case. The initial release in March is considered to be the fully updated version for each year. While pharmaceutical companies and medical agencies have to pay to receive MedDRA updates, medical regulators receive free access to all updates and information for this complex coding system. Anyone who is interested can sign up to have access to this system. Although the majority of the information contained in the MedDRA coding dictionary covers medical products, there are some allowances for medical conditions. These are referred to as Standardized MedDRA queries, or SMQs. These can be especially helpful for reporting purposes. MedDRA's initial implementation for medical products coding started in 1999, and it has spread quickly throughout the world as one of the most reliable coding methods for researchers, regulators, and medical personnel. MedDRA coding may only be 15 years old, but its usefulness as an international medical tool has become so vital that countries actually require its use. As the dictionary continues to grow and the system's popularity continues to grow, it is poised to be one of the most heavily used medical product coding systems in the world. To learn more visit http://www.clinplus.com.
Published on Nov 13, 2013
Published on Nov 13, 2013
MedDRA is a beneficial system which bridges the language barriers of medical professionals throughout the world. This system allows for med...