The Role of the Statistician in the Data Management Process
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0092-8615/2001 Copyright 0 2001 Drug lnformation Association Inc.
Printed in the USA. All rights reserved.
THE ROLE OF THE STATISTICIAN IN THE DATA MANAGEMENT PROCESS ANNEKEC. GROBLER, MSc, SHARONL. HARRIS, BSc HONS, AND HANNA-LIZA JOOSTE, BSC HONS Biostatisticians, Quintiles ClinData, Bloemfontein, South Africa
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-biostatisticsteam, 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 perjormed to evaluate the integrity of a database. Finally, pegorming a statistical review on the database prior to database lock can detect anomalies that would otherwise only show up during analysis. Key Words: Quality of database; Case report form design; Statistics; Data validation; Database review
INTRODUCTION “No study is better than the quality of its data” Friedman, et al., 1981
DATA MANAGEMENT IS AN integral part of clinical studies. Data management delivers a database to statisticians and programmers for statistical analysis and the production of a research report. As the database is seldom the end-product of a clinical study, it is usually to the advantage of all disciplines if the statistician (as a user of the database) is involved in aspects of data management. The statistician can help to ensure that the database fits the requirements of the statistical analysis and production of the research report. The involvement of the statistician,
Reprint address: Anneke C. Grobler, Quintiles ClinData, 1 Third Avenue, Westdene, Bloemfontein, 9301, South Africa. E-mail: [email protected].
not only in the statistical analysis and report writing, but also in the study design and data management, can enhance the quality of the clinical trial and facilitate the work of other parties in the clinical trial process (1). This article discusses the role of the statistician in the data management process. Three aspects of the data management process are discussed: 0
Trial design (protocol and case report form), Design, validation, and quality control of a database, and Statistical review of a database.
THE ROLE OF THE STATISTICIAN IN TRIAL DESIGN Every aspect of a trial, including data management, depends on good trial design. Data managers are usually not consulted during
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Anneke C. Grobler, Sharon L. Harris, and Hanna-Liza Jooste
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trial design. Good Clinical Practice (GCP) guidelines
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