Download A Manager's Guide to the Design and Conduct of Clinical by Phillip I. Good PDF

By Phillip I. Good

Content material:
Chapter 1 reduce charges and elevate earnings (pages 1–8):
Chapter 2 instructions (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 protecting Physicians and sufferers (pages 95–108):
Chapter 10 Computer?Assisted information 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 dealing with the rigors (pages 155–164):
Chapter 15 info research (pages 165–198):
Chapter sixteen fee (pages 199–208):

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Extra info for A Manager's Guide to the Design and Conduct of Clinical Trials

Example text

CHECK N. Complete the Submission. Prepare final report to regulatory agency. See Chapter 8. Review study with regard both to study weaknesses and to findings that may serve as the basis for future studies. Prepare an After-Action Review. See Chapter 16. Review the cost ledger with a view toward preparing budgets for future studies. Check with marketing regarding preparation of journal articles, physician guides, and the like. Begin long-term follow-up and collection of postmarketing adverse event data.

But it was decided that the more accurate CHAPTER 5 DESIGN DECISIONS 33 and “official” reading would be made from an angiogram by an independent laboratory. —patients have been known not to appear as scheduled for follow-up exams. What if a patient dies during the study or requires a further remedial operation? How is the end point of such a patient to be defined? Don’t put these decisions off till some later date; make them now and make them in writing lest you risk not collecting the data you will ultimately need.

Severity of the symptom or disease at some fixed point after the start of treatment. This latter can be expressed either in terms of (a) a mean value or (b) the proportion of individuals in the study population whose severity lies below some predetermined fixed value. 32 PART I PLAN END POINT OR SURROGATE? I’m taking drugs currently to control my blood pressure and to lower my cholesterol. Thus my interests will be served if my diastolic blood pressure remains below 90 and my cholesterol dips below 200.

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