A Data Model for Clinical Study Status Reports
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Drug Information Journal. Vol. 32, pp. 887-895. 1998 Printed in the USA. All rights reserved.
Copyright 0 1998 Drug Information Association Inc.
A DATA MODEL FOR CLINICAL STUDY STATUS REPORTS DAVIDH. CHRISTIANSEN, DRPH Principal Biostatistician
DAVESUNDIN,MS Applications Analyst Medical Affairs Department, Genentech, Inc., South San Francisco, California
Status reports for clinical studies are an important tool in the successful conduct of a clinical research project. They deliver timely information to the study team thatfacilitates the effective management of the study. Development and implementation of these reports requires integration of information from a number of sources including clinical data, study planning data, resource h t a . and timelines. A model for creating a database that allows for easy generation of various types of reports f o r monitoring study status is defined. Once the terminology and algorithms have been defined, some examples of the use of this model in an ongoing clinical study are shown. These reports have proven useful to each member of the study team in a variety of ways. Key Words: Clinical study; Data; Status reports
INTRODUCTION STATUS REPORTS FOR clinical studies are an important tool in the successful conduct of a clinical research project. These status reports typically consist of a series of comparisons of planned outcomes to the actual outcomes observed. For example, expected patient enrollment can be compared to the actual patients enrolled over the recruitment period. From site planning (preinitiation) to report writing (study completion), many different aspects of study status can be monitored. The first step in the process is, of course, deciding what and when to monitor. Once this is established, data sources must be identified, data flow must be defined, and report
specifications must be outlined. Some of the data needed for these reports can be obtained from the clinical data collected to meet the scientific objectives of the study. Other data may be obtained from administrative sources or may be generated to track data flow and error correction processes. This paper will define the types of data, their sources, and the structure of the database required for reporting study status. The paper will also give some examples of report types that can be generated and uses for these reports. The results of applying the data model to an ongoing clinical trial will be presented and discussed.
STUDY STATUS CONCEPTS
Study status reports facilitate the effective management of a clinical study. These reReprint address: Dr. David Christiansen. Genentech, ports summarize the status of a variety of Inc.. 1 DNA Way, South San Francisco, CA 94080data items associated with the conduct of the 4990. 887 Downloaded from dij.sagepub.com at UNIV NEBRASKA LIBRARIES on June 5, 2016
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David H. Christiansen and Dave Sundin
study. The flow of these items through the clinical trials process to the data warehouse is defined as a data stream. A typical clinical project or trial will con
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