The Role of the Statistician in the Data Management Process

Abstract

The statistical results from a clinical trial rely on the accuracy and completeness of the database used to generate the results. The quality of the database depends on the quality of the data collection methods and the data management procedures. As part of the data management-biostatistics team, a statistician can ensure that a protocol is written in such a manner as to enhance data management; a statistician’s input into the subsequent design of the case report form can facilitate the collection of appropriate and complete data. A statistician can contribute to the accuracy and validity of a database by providing input into the design of both the database structure and data plausibility checks, and the quality control procedures performed to evaluate the integrity of a database. Finally, performing a statistical review on the database prior to database lock can detect anomalies that would otherwise only show up during analysis.