By Phillip I. Good
This enticing and non-technical advisor to scientific trials covers concerns research layout, association, administration, research, recruitment, reporting, software program, and tracking. loose from the jargon-laden therapy of different books, A Manager’s advisor to the layout and behavior scientific Trials is equipped upon the formulation of first making plans, then imposing, and eventually acting crucial assessments. deals an government point presentation of managerial instructions as good as convenient checklists observed by means of extracts from submitted protocols comprises checklists, examples, and suggestions, in addition to an invaluable appendix on to be had software program Covers e-submissions and use of desktops for direct info acquisition comprises funny but instructive and precise anecdotes to illustrate universal pitfalls
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Extra resources for A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series)
At least one member of the software design team should be from the testing group to ensure that quality is built in from the start. Test the Software Those who develop the software should be no more permitted to organize the ﬁnal testing stages than a starting quarterback would be permitted to call defensive signals. For just as American football today has one team for offense and a second team for defense, so too should you have one team for development and one for testing: the two tasks require quite different mind-sets.
A typical set of clinical trials today costs what that wasted spaceshot did in the 1950s. We needn’t make the same mistakes that were made back then. Find the discrepancies and take advantage of the immediate availability of information that computer-assisted data entry provides to plug the holes as they arise. PAY FOR RESULTS, NOT INTENTIONS The most expensive single item in any study today is the physician’s fee. Well, perhaps hospital charges can be appreciable as well. But you don’t pay the hospital until after the surgery is completed and the patient discharged.
The assignment-of-cause committee would consist of specialists in the disease process. The trial modiﬁcation committee should include a statistician as well as physicians. All the committees should be able to call on additional experts—bioengineers, epidemiologists, geneticists, or pharmacologists—whenever they feel such services are warranted. The primary duty of committee members is to ensure the safety of the participants in the trials. Their secondary responsibility is to ensure the integrity of the trials: the investigators, the regulatory agency, and the sponsor will rely on their advice.
A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) by Phillip I. Good
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