By Phillip I. Good
Chapter 1 minimize expenditures and elevate gains (pages 1–8):
Chapter 2 directions (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 protecting Physicians and sufferers (pages 95–108):
Chapter 10 Computer?Assisted information access (pages 109–124):
Chapter eleven facts administration (pages 125–140):
Chapter 12 Are you prepared? (pages 141–144):
Chapter thirteen tracking the pains (pages 145–154):
Chapter 14 handling the pains (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
Specify design parameters as defined in Chapter 6 including all of the following: • Treatment you will use with the control group. • Extent to which investigators will be permitted knowledge of the specific treatment each patient receives. • Whether you will utilize an intent-to-treat protocol. • Degree of confidence you wish to have in the final results. • Sample size required. Be aware of regulatory requirements. asp. Put your major effort into Don’t collect data you don’t need preparing for the trials, not in Store and analyze the data you repairing them.
See Chapter 10. Steps H–J can be done together. H. Train. Three topics should be covered in a training program for the investigators and their staffs. See Chapter 10. 1. Details of the intervention. The procedures manual developed in Chapter 8 will serve as text. 2. Data entry 3. Ensuring patient compliance I. Recruit Patients. Recruit and enroll patients and put in place measures to monitor and ensure patient compliance. See Chapter 9. J. Set up External Review Committees. Their composition is considered in Chapter 4 and their functions in Chapters 4 and 14.
THE WRONG WAY The wrong way to plan a study is to begin with the forms that were used in a previous set of trials. The sole reason for such a choice, regardless of all proffered rationalizations, is to shift the blame in case something goes wrong. The forms from a previous study seldom make even a good “starting point” (an often heard suggestion). Would you line up for the 100-meter hurdles where you stood to hurl the javelin? Never mind where the starting point used to be, locate the finish line, then back up 100 meters.
A Manager's Guide to the Design and Conduct of Clinical Trials by Phillip I. Good