Quality Management In The Clinical Study Report Project

Globalization created a large demand for translation of clinical trial reports and other medical documents.Thus it is a necessity to summarize scientific methods and strategies for quality management.The reporter worked as a translator in a team responsible for the clinical study report project.Requirement analysis was launched before the practice.A conclusion was drawn that this project required a high degree of professionalism,which was embodied in text professionalism,material preparation,personnel capability,team cooperation,etc.According to the characteristics of the project,project management was accomplished in aspects like project scope,time,resources,communication,quality,etc.Agile model was adopted and the translation texts were delivered in batches to ensure the quality of the translation.Methods were used to find language resources.To ensure the translation quality,daily checks were launched and a medical professional was introduced to review and answer questions for translators.Problems occurred in translator’s ability,time control,communication,and cooperation.Methods were taken to solve the problems encountered in the process.A closing meeting was held to summarize the problems and methods used in this project.The reporter summarized the language resources she collected and the lessons she learned.Through this project,the reporter learned the importance of quality management of medical translation in terms of text quality,professionalism and consistency of terminology,searching ability,translator capability,team cooperation,etc.She learned the necessary work ethic and abilities to work in a team.She also found out that the improvement of translators’ capability cannot be without practice in many aspects,especially the problem-solving ability.Experience and guidance were gained in this internship,which would help her in the translation practice in the future.