Project planning, investigator selection, data harmonization.

Abstract

This paper has presented certain concepts and thoughts regarding the planning process and dealt with two areas where planning and preconsideration of problems will aid in the quality, speed and efficiency of ones programs. The varied examples that have been cited are just that; they are not intended to be a comprehensive evaluation of all the aspects of the planning process or, for that matter, the selection of investigators or harmonization of data. They are intended instead to illustrate the way in which a comprehensive and thorough planning approach to project management can facilitate, ease and improve the quality of the work we do. The important point of this whole paper is not so much the individual benefits to be gained from any one of the systems described, but rather to illustrate as much as possible the value of planning in our process. It is incumbent on us to search for ways to improve the way in which we do or work. Standards have improved considerably over the years, but there is much room for further improvement; good clinical and scientific thought will inevitably continue to contribute to the improvement of those programs. The submission of this author, however, is that if we do these in advance, we will solve them a good deal faster and a good deal more efficiently than if we constantly react to new and developing problems.