Medical Dictionary for Regulatory Activities MedDRA

Adverse events need to be coded consistently with respect to letter case. Problems can occur when there is discordant coding using all capital letters, all lower-case letters, or combinations thereof, as computer software will interpret these capitalization variations as different events. Letter case sensitivity can be important when two or more words are used to describe an adverse event. For example, some databases utilizing the Medical Dictionary for Regulatory Activities (MedDRA) coding dictionary employ a coding system in which only the first letter of the first word of an adverse event is capitalized (e.g., Atrioventricular block complete ). Failing to adhere to uniform letter case conventions across the data can result in severe errors in data analysis. 

The Medical Dictionary for Regulatory Activities (MedDRA) is a creation of the International Conference on Harmonization, and it is used to categorize and code diseases, disorders, and adverse events. The five levels and associated codes to the MedDRA coding hierarchy are as follows ... 

Brown, E.G., Wood, L., and Wood, S. (1999). The Medical Dictionary for Regulatory Activities (MedDRA). Drug Safety 20 109-117. 

There is a plethora of medical terminologies available but the Medical Dictionary for Regulatory Activities (MedDRA) has been adopted by the ICH as the standard medical terminology for regulatory communication. 

Nilsson ME, Koke SC (2001) Defining treatment-emergent adverse events with the medical dictionary for regulatory activities (MedDRA). Drug Information Journal 35 1289 1299. 

How to identify subjects with each AE of special interest. This includes specifying the medical definition of the AE of special interest (preferably, an established definition in the medical literature). Identification of subjects may include any of the following utilization of a search strategy in the Medical Dictionary for Regulatory Activities (MedDRA) or other dictionary utilization of a special case report form and/or adjudication. For example, it may be possible to utilize a standardized MedDRA query (SMQ) (see the MedDRA site). If a special case report form is developed, details of special collection may be included in the PSAP section on "Data Collection Plan and Standardization Approaches." If the AE of special interest definition will include event adjudication, detailed information on the adjudication process or a link to more detailed information should be included. It is recommended to have a common definition for an AE of special interest for the entire development program, in order to facilitate data integration, analysis, and interpretation. 

Adverse events include those that may be attributable to the underlying disease. Figures in parentheses represent percentage. MedDRA = Medical Dictionary for Regulatory Activities (http // www.meddramsso.com/NewWeb2003/medra overview/index. htm) NOS = not otherwise specified. 

MedDRA Medical Dictionary for Regulatory Activities Terminology... 

Methods for handling the safety and tolerability data the safety data will usually be coded using the MedDRA (Medical Dictionary for Regulatory Activities, www.meddramsso.com) coding system in order to aid summary and presentation... 

Pharmaceutical companies, individual regulatory authorities and the WHO have databases which facilitate this overview. The use of a standard coding dictionary of adverse event terms is essential for this sort of analysis, and one, MedDRA (Medical Dictionary for Regulatory Activities) has been accepted as the gold standard to be used. Nevertheless, routine review of individual cases by responsible, experienced reviewers is the most essential factor in identifying new signals and ensuring patient protection. 

MedDRA. Medical Dictionary for Regulatory Activities. Available http //www.meddra. org. Accessed August 1,2014. 

MedDRA the Medical Dictionary for Regulatory Activities terminology is the international medical terminology developed imder the auspices of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use 2012. 

MedDRA. Medical dictionary for regulatory activities. http //www.meddramsso. com/, 2013. Accessed August 7,2014. 

MedDRA Medical Dictionary for Drug Regulatory Activities... 

The current structure of MedDRA is defined in Table 21.6. There will be a central maintenance organization responsible for development, user support, implementation and communication as well as an international user group. A management board will oversee the activities of the central maintenance organization with direction provided by the ICH Steering Committee. A standard medical dictionary will facilitate electronic data exchange between industry and regulatory authorities worldwide, as recommended by the ICH. 

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