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

By Phillip I. Good

This enticing and non-technical advisor to scientific trials covers concerns examine layout, association, administration, research, recruitment, reporting, software program, and tracking. loose from the jargon-laden remedy of alternative books, A Manager’s advisor to the layout and behavior medical Trials is equipped upon the formulation of first making plans, then enforcing, and at last appearing crucial assessments. deals an govt point presentation of managerial guidance as good as convenient checklists followed through extracts from submitted protocols comprises checklists, examples, and tips, 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 actual anecdotes to illustrate universal pitfalls

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Sample text

What sample size is necessary to detect the effect? 5. How many examination sites will we need? PRE-DESIGN CHECKLIST Before you can begin full-scale clinical trials, you need to establish: • • • • Mutagenicity, carcinogenicity, and toxicity in animals Mechanism of action in humans Maximum tolerated dose Minimum effective dose CHAPTER 5 DESIGN DECISIONS 29 We deal in Chapter 7 with the large number of minor details that must be thought through before we can conclude our preparations. SHOULD THE STUDY BE PERFORMED?

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.

K. Conduct the Trials. • • • • • • • Review checklist. See Chapter 12. Maintain a database and provide for its security. See Chapter 11. Maintain a schedule of regular visits to the investigators (in parallel with L). See Chapter 13. Collate data (in parallel with L). See Chapter 14. Prepare and review interim reports. Follow up on discrepancies and missing values immediately. See Chapter 14. Call meetings of the safety committee if necessitated by adverse event reports. Pay physicians and testing laboratories as completed reports are received.

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