A Manager's Guide to the Design and Conduct of Clinical Trials
Seiten
2002
John Wiley & Sons Inc (Verlag)
978-0-471-22615-4 (ISBN)
John Wiley & Sons Inc (Verlag)
978-0-471-22615-4 (ISBN)
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Any medical products must go through a lengthy development and approval process prior to release onto the market. This non-technical guide to clinical trials covers issues of study design, organization, management, analysis, recruitment, reporting, software, and monitoring.
This engaging and non--technical guide to clinical trials covers issues study design, organization, management, analysis, recruitment, reporting, software, and monitoring. Free from the jargon--laden treatment of other books, A Manager's Guide to the Design and Conduct Clinical Trials is built upon the formula of first planning, then implementing, and finally performing essential checks. Offers an executive level presentation of managerial guidelines as well as handy checklists accompanied by extracts from submitted protocols Includes checklists, examples, and tips, as well as a useful appendix on available software Covers e--submissions and use of computers for direct data acquisition Incorporates humorous yet instructive and true anecdotes to illustrate common pitfalls
This engaging and non--technical guide to clinical trials covers issues study design, organization, management, analysis, recruitment, reporting, software, and monitoring. Free from the jargon--laden treatment of other books, A Manager's Guide to the Design and Conduct Clinical Trials is built upon the formula of first planning, then implementing, and finally performing essential checks. Offers an executive level presentation of managerial guidelines as well as handy checklists accompanied by extracts from submitted protocols Includes checklists, examples, and tips, as well as a useful appendix on available software Covers e--submissions and use of computers for direct data acquisition Incorporates humorous yet instructive and true anecdotes to illustrate common pitfalls
PART I: PLAN. 1. Cut Costs and Increase Profits. 2. Guidelines. 3. Prescription for Success. 4. Staffing for Success. 5. Design Decisions. 6. Trial Design. 7. Exception Handling. PART 2: DO. 8. Documentation. 9. Recruiting and Retaining Physicians and Patients. 10. Computer-Assisted Data Entry. 11. Data Management. 12. Are You Ready? 13. Monitoring the Trials. 14. Managing the Trials. 15. Data Analysis. PART 3: CHECK. 16. Check. Appendix: Software. Author Index. Subject Index.
| Erscheint lt. Verlag | 6.9.2002 |
|---|---|
| Zusatzinfo | illustrations |
| Verlagsort | New York |
| Sprache | englisch |
| Maße | 161 x 240 mm |
| Gewicht | 539 g |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
| ISBN-10 | 0-471-22615-7 / 0471226157 |
| ISBN-13 | 978-0-471-22615-4 / 9780471226154 |
| Zustand | Neuware |
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