Conducting Clinical Trials

Conducting Clinical Trials by Frank L. Iber, W. Anthony Riley, Patricia J. Murray.

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 endure...

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Bibliographic Details
Main Authors: Iber, Frank L. (Author), Riley, W. Anthony (Author), Murray, Patricia J. (Author)
Corporate Author: SpringerLink (Online service)
Format: eBook
Language:English
Published: New York, NY : Springer US : Imprint: Springer, 1987.
Edition:1st ed. 1987.
Series:Springer eBook Collection.
Subjects:
Pharmacology.
Medicine.
Electronic resources (E-books)
Online Access:Click to view e-book
Holy Cross Note:Loaded electronically.
Electronic access restricted to members of the Holy Cross Community.
Table of Contents:
  • 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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