Clinical Data Management Requires Clean Data in the Coding Process
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Drug Information Joumal. Vol. 33, pp. 91-93, 1999 Printed in tbe USA. AU rights reserved.
CLINICAL DATA MANAGEMENT REQUIRES CLEAN DATA IN THE CODING PROCESS ANNAJAKUBOWSKA, MD, MBA Rhone Poulenc Rorer, Collegeville, Pennsylvania
SONIA SOUZA,
PHD
RPR Gencell, Santa Clara, California
CHRISTIAN FIZAMES,MD, MF% RPR Antony, France
The clinical coding process is one of the areas where clean data are vital for good statistical analysis. The timeliness of data collection and analysis is extremely important to the process. Obstacles to obtaining clean data begin with understanding the medical Ianguage and good diagnosis. Developing an understanding of the variability of the medical language and how it impacts the clinical data will ensure better quality throughout the whole clinical process. The investigator along with his staff and their interaction with the clinical research associates (CRAs) are critical to an effective clinical coding process. Involving the CRAs directly in the coding process improves the quality of the data collected. Finally, by ensuring clean quality of data early in the process, researchers can provide senior management with early dependable data so they can more effectively manage projects. Key Words: Clinical data management; Clean data; Coding
THERE IS AN ONGOING effort to develop
lection, clean-up of the database, and improvement in the overall usability and quality of the collected data. Real-time coding is one activity that will improve the understanding of the variables, allow for an early intervention in the data collection process, reduce the overall time to achieve clean data, and truly have an impact on the quality and usability of the data. Improving the overall quality and usability of the data while reducing the time from collection to analysis will increase confidence in the results and provide earlier direction to senior management to effectively manage projects. The coding process deals with language. In learning to clearly express themselves people develop terms with specific mean-
systems for obtaining clean data in clinical trials. It is common in a clinical trial to collect a large amount of data that cannot be summarized or analyzed. Often queries are unresolved because too much time has elapsed since the information was written on the patients’ charts and the sponsor has not requested information because of a lack of understanding of the variables being collected. Several alternatives have been evaluated in attempts to reduce time for data col-
Reprint address: Anna Jakubowska, MD, MBA, Rhone Poulenc R o w , 500 Arcola Rd., Collegeville, Pennsylvania, 19426.
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Anna Jakubowska, Sonia Souza, and Christian Fizames
ings. On the surface this seems quite simple. Often, however, a single term is no longer sufficient to describe a complex concept, so new terms are created to provide a more accurate meaning. Science and medicine have been among the largest fields for developing ne
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