MedDRA

MedDRA is a very large medical classification with more than 60,000 scientific words and phrases. The MedDRA data dictionary is accepted as an international standard terminology for global use by all pharmaceutical, biotechnology and related Industries. Widely accepted in the United States, Europe and Japan, MedDRA terminology is the preferred language for New Drug Applications submitted to the FDA and for describing Adverse Event Reporting (AEP) as required by governmental regulations. Therefore, MedDRA training is highly recommended to all persons involved in clinical trials. Promoting Medical accuracy and consistency in the coding and reporting data, require obligatory a good training and explanation of coding Philosophy and MedDRA structure, classification and specificity. The adoption of MedDRA will impact all areas of the organization that collect, code, analyse, or report medical information. Functional areas such as drug safety, information technology, biostatistics, and clinical data management will be heavily affected. Clinical Investigators, Study coordinators, CRAs, Statisticians and Data Managers should be trained in the use of MedDRA dictionary. The objective of this is to reduce the number of company queries and correction forms that are generated back to clinical research sites and to help understanding MedDRA’s impact on analysis and help improving search strategies through the dictionary hierarchy.

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