By Phillip I. Good
This attractive and non-technical consultant to scientific trials covers matters research layout, association, administration, research, recruitment, reporting, software program, and tracking. unfastened from the jargon-laden therapy of different books, A Manager’s consultant to the layout and behavior medical Trials is equipped upon the formulation of first making plans, then enforcing, and eventually appearing crucial tests. deals an government point presentation of managerial instructions as good as convenient checklists observed through extracts from submitted protocols comprises checklists, examples, and assistance, in addition to an invaluable appendix on to be had software program Covers e-submissions and use of pcs for direct information acquisition contains funny but instructive and real anecdotes to illustrate universal pitfalls
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Additional resources for A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series)
Use computer-assisted data entry to catch and correct data entry errors as they are made (see Chapter 10). Ensure the integrity and security of the stored data (see Chapter 11). Prepare a highly detailed procedures manual for the investigators and investigational laboratories to ensure uniformity in treatment and in measurement. Provide a training program for the investigators with the same end in mind. This manual should include precise written instructions for measuring each primary and secondary end point.
The result, as one might expect, is both increased turnover of personnel and a degradation in the quality of the data that is collected. The smart drug or device company will pay all or most of the salary of a coordinator at each site, thus ensuring both quality and continuity. Moreover the medical records of most physician ofﬁces today are paper-oriented. A trained coordinator onsite is essential to facilitate the conversion to direct data entry, to ensure that computers are placed where they lend themselves to immediate use.
What units will be used? Who will interpret the measurements? What quantitative results do you expect? You must test for safety. What short-term side effects are expected? How do you plan to measure them? What quantitative results do you expect? How soon can you expect to observe them? What long-term side effects are expected? How do you plan to measure them? What quantitative results do you expect per 100 patients? those events directly related to the intervention that exceed a certain level of severity.