Abstract
Successful completion of any study is the timely preparation and distribution of an accurate, understandable, and useful report. The report should include all details of study procedures and results plus conclusions based on thoughtful consideration of the data. Overall, responsibility for a study report should belong to the study director. Contributing scientists and scientific writers should work closely with the study director in establishing timing and format. Review by one or more peers is an effective means of assuring that the report is scientifically valid and that conclusions drawn are sound and accurate. Review by the quality assurance unit (QAU) helps assure that the report accurately reflects the raw data and that all pertinent data are included in the report. However, although the foregoing are necessary, they are not sufficient. It is crucial that the study director and other report contributors have a clear understanding of the expectations and needs of the sponsor before the report is assembled. A total quality approach to planning and preparing the report will result in a high-quality document.