By Phillip I. Good
Chapter 1 minimize charges and bring up gains (pages 1–8):
Chapter 2 directions (pages 9–14):
Chapter three Prescription for Sucess (pages 15–18):
Chapter four Staffing for achievement (pages 19–28):
Chapter five layout judgements (pages 29–46):
Chapter 6 Trial layout (pages 47–54):
Chapter 7 Exception dealing with (pages 65–72):
Chapter eight Documentation (pages 73–94):
Chapter nine Recruiting and conserving Physicians and sufferers (pages 95–108):
Chapter 10 Computer?Assisted info access (pages 109–124):
Chapter eleven information administration (pages 125–140):
Chapter 12 Are you prepared? (pages 141–144):
Chapter thirteen tracking the rigors (pages 145–154):
Chapter 14 coping with the pains (pages 155–164):
Chapter 15 facts research (pages 165–198):
Chapter sixteen cost (pages 199–208):
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Extra resources for A Manager's Guide to the Design and Conduct of Clinical Trials
Tertiary End Points. Tertiary end points such as costs may or may not be essential to your study. Don’t collect data you don’t need. When in doubt, let your marketing department be your guide. BASELINE DATA You will need to specify what baseline data should be gathered prior to the start of intervention and how it will be gathered—by interview, questionnaire, physical examination, specialized examinations (angiograms, ultrasound, MRI), and/or laboratory tests. Baseline data CHAPTER 5 DESIGN DECISIONS 35 will be used both to determine eligibility and, as discussed in the next chapter, to stratify the patients into more homogeneous subgroups.
We should always hesitate to undertake extensive trials when a surgical procedure is still in the experimental stages, or when the crosseffects with other commonly used drugs are not well understood. A cholesterol-lowering agent might well interfere with a beta blocker, for example. If your study team is still uncertain about the intervention’s mode of action, it may be advisable to defer full-scale trials till a year or so in the future and perform instead a trial of more limited scope with a smaller, more narrowly defined study population.
The testing leads are responsible for developing automated testing routines using such 22 PART I PLAN screen-capture utilities as WinRunner. ) While the leads need to have a thorough understanding of the critical distinctions among unit, integration, and stress testing, the balance of the formal testing team can and ought to be relatively unskilled in computer use. Their task is to simulate the sort of errors that similarly unskilled personnel can make when the software is actually in use in the field.