International Journal of Medicine and Data

Objective To summarize the practical experience of MedDRA coding to improve the accuracy of drug clinical trial data coding. Methods Through a retrospective analysis of the coding practice of 20,000 words, various situations and strategies encountered during the coding of drug clinical trials using MedDRA were summarized with specific examples, including word splitting, automatic coding review and coding challenge. Results The use of automatic coding system greatly improved the coding efficiency, but also had some limitations. Words with multiple meanings, multiple words with one meaning, and words that need to be split and clarified all require manual judgment and coding, and cannot be replaced by the system at present. Conclusion Currently, although the use of automatic coding systems has significantly improved work efficiency, the process of manual coding and medical review is still indispensable.

Medical coding; Drug clinical trials; Automatic coding