A Team-Oriented Approach to the Analysis and Reporting Process
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Drug Idonnatwn Journal. Vol. 31. pp. 665-670. 1997 R i n d in the USA. Au rights reserved.
A TEAM-ORIENTED APPROACH TO THE ANALYSIS AND REPORTING PROCESS BETHB. HAURY,MA Manager, Medical Writing and Regulatoly Documents
PHILIP
M. BROWN,MD, JD
Associate Vice President, Medical Affairs
MICHAELN. BOYD,PHD Director, Biostatistical Services
CINDYHOLLANDER Senior ProgrammedAnalyst Warmaceutical Research Associates. Inc., Charlottesville. Virginia
Coordinating the writing component with the operational components of a clinical trial can be very challenging. Traditionally, the final integrated report has been completed by a writing department, whose members may not have hod regular access to the operational groups who conducted the trial. Access to these operational groups can be particularly dificult when the report is written by a contract research organization (CRO). To minimize problems of coodination between CRO and client and to maximize the clarity and accuracy of the report, Pharmaceutical Research Associates, Inc. has developed a model that involves a “team”of operations personnel in a matrix-like environment who each participate in both the conduct of the trial and in the completion of the final srudy report. Each reporting team is a subset of the larger;full-service project team and consists of representativesfrom biostatistics, analysis programming. medical writing, regulatory services, and medical affairs. The team produces a final study report in five distinct stages, each of which is passed to the client for approval before the subsequent stage is produced. By involving diverse team members throughout a reporting project, a CRO can provide clients with a high-quality and efficiently produced report while maximizing enthusiasm and cooperation among team members.
Kcy Wordr: Writing team; Reporting process; CRO;Reporting team;Project team
tant aspect of the trial itself. The report is the culmination of months to years of work FINAL* INTEGRATED report Of a performed by a large number of individuals trial arguably may be the most imprwhose expertise covers the broad range of basic science, medicine, regulatory affairs, data management, programming, statistics, Presented at DIA Workshop “Medical Writing” &toand medical writing. During the trial, great ber 30-3 1, 1995, Philadelphia, Pennsylvania. care is taken that a proper experimental deReprint address: Beth B. Hawy, Manager, Medical sign is followed, that data are accurately colWriting and Regulatory Documents, Pharmaceutical Research Associates, 2400 o l d I V ~~~ala^- lected and entered into a database, and that data are properly summarized and analyzed. ville. VA 22903.
INTRODUCTION
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Beth B. Haury,Philip M. Brown, Michael N. Boyd, and Cindy Hollander
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The successful, integrated report presents this complex, specialized information in language that will satisfy the specialist but that can be understood by the more general audience of managers and r
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