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CONDUCTING CLINICAL TRIALS 198 als Buch
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CONDUCTING CLINICAL TRIALS 198

Auflage 1987. Sprache: Englisch.
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A few years ago, two of us joined our senior colleague at Pharma­ Kinetics Laboratories, a newly public contract research firm just under­ taking a major expansion into the clinical trials market. The company's unique concept of clinical re… weiterlesen
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CONDUCTING CLINICAL TRIALS 198 als Buch

Produktdetails

Titel: CONDUCTING CLINICAL TRIALS 198
Autor/en: Frank L. Iber, W. Anthony Riley, Patricia J. Murray

ISBN: 0306426269
EAN: 9780306426261
Auflage 1987.
Sprache: Englisch.
SPRINGER VERLAG GMBH

30. September 1987 - gebunden - 366 Seiten

Beschreibung

A few years ago, two of us joined our senior colleague at Pharma­ Kinetics Laboratories, a newly public contract research firm just under­ taking a major expansion into the clinical trials market. The company's unique concept of clinical research held great promise and had suc­ cessfully endured many of the fits and starts characteristic of entrepre­ neurial organizations. With a staff of highly enthusiastic, albeit inex­ perienced, field personnel located in 30-odd cities around the country, we found ourselves off and running with several critical research pro­ grams for major pharmaceutical manufacturers. Our excitement with the innovation was tempered with the reality of staffing and bearing responsibility for more than 30 field offices and 300 new staff persons, more than half of whom had no previous experience in the pharma­ ceutical industry. In the ensuing few years, we explored by trial and error many workable and unworkable patterns of training! delegation, data collec­ tion, and auditing. The ideas expressed in this book benefited greatly from that experience and from the willingness of our co-workers and clients to share insights and problems. During those years, we also sought guidance from the works available on the clinical trials field. Although we found numerous references on research ethics, little guid­ ance was available on the practical aspects of conducting a clinical trial.

Inhaltsverzeichnis

I. Introduction.- 1. Introduction.- II. Entering the Field of Clinical Trials.- 2. Deciding to Enter the Research Field.- 3. Physicians.- 4. Evaluating a Sponsor.- 5. Budget Planning and Development.- 6. Staff Selection and Training.- 7. Other Preparatory Activities.- III. The Institutional Review Mechanism.- 8. The Institutional Review Board Process.- IV. The Recruitment Process.- 9. Recruitment.- V. Critical Decision Points in a Clinical Trial.- 10. Informed Consent: Decision amid Uncertainty.- 11. Special Populations.- 12. The Enrollment/Continuation Decision.- 13. Compliance of Patients Currently on Study.- 14. Adverse On-Therapy Experiences.- 15. The Referral Process.- VI. Data Management.- 16. Principles of Data Management.- 17. Scheduling and Log Systems.- 18. The Research Chart.- 19. Study Checklists.- 20. The Case Report Form.- 21. Records of Excluded Patients.- 22. Regulatory Document Files.- 23. Record Storage and Access.- 24. Computer Technology in Data Management.- VII. Drug Accountability.- 25. Drug Accountability.- VIII. Enhancing Credibility.- 26. Publications and Presentations.- 27. Preventing Fraud.- 28. Quality Assurance.- 29. FDA Inspections.- IX. Appendixes.- A. Glossary.- B. Adverse Reaction Report.- C. Statement of Investigator.- D. General Reading.
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