By Phillip I. Good
Chapter 1 reduce bills and raise earnings (pages 1–8):
Chapter 2 guidance (pages 9–14):
Chapter three Prescription for Sucess (pages 15–18):
Chapter four Staffing for fulfillment (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 holding Physicians and sufferers (pages 95–108):
Chapter 10 Computer?Assisted facts access (pages 109–124):
Chapter eleven info administration (pages 125–140):
Chapter 12 Are you prepared? (pages 141–144):
Chapter thirteen tracking the rigors (pages 145–154):
Chapter 14 handling the rigors (pages 155–164):
Chapter 15 facts research (pages 165–198):
Chapter sixteen money (pages 199–208):
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Extra info for A Manager's Guide to the Design and Conduct of Clinical Trials
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.
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. You should also determine how the adverse event data are to be collected. By use of a checklist—“Since your last appointment, did you experience fever?
0” and “1” may have offered space-saving advantages in the 1960s when a minicomputer provided only four thousand characters (kilobytes) of memory and tape was used for mass storage, but today when even a personal computer’s memory measured in millions of characters and compact disks hold billions of bits of information, you might just as well store “Y” or “yes” for yes as convert Y to a 1. ” As with all things simple, eliminating codes eliminates timewasting coding and decoding as well as a major source of error.
A Manager's Guide to the Design and Conduct of Clinical Trials by Phillip I. Good