Principles and Practice of Clinical Research

1. A Historical Perspective on Clinical Research Part I - Ethical, Regulatory and Legal Issues 2. Ethical Principles in Clinical Research 3. Integrity in Research: Principles for the Conduct of Research 4. Institutional Review Boards 5. The Regulation of Drugs and Biological Products by the Food and Drug Administration 6. International Regulation of Drugs and Biological Products 7. Data Management in Clinical Trials 8. Data and Safety Monitoring 9. Unanticipated Risk in Clinical Research 10. Legal Issues 11. Inclusion of Women and Minorities as Subjects in Clinical Research 12. Accreditation of Human Research Protection Programs 13. The Role and Importance of Clinical Trials Registries 14. The Clinical Researcher and the Media 15. Clinical Research: A Patient PerspectivePart II - Biostatistics and Epidemiology 16. Design of Observational Studies 17. Design of Interventional Studies and Trials 18. Issues in Randomization 19. Hypothesis Testing 20. Power and Sample Size Calculations 21. An Introduction to Survival Analysis 22. Intermediate Topics in Biostatistics 23. Measures of Function and Health-Related Quality of Life 24. Large Clinical Trials and Registries: Clinical Research Institutes 25. Meta-analysis of Clinical Trials 26. Using Large Datasets for Population-based Health Research 27. Development and Conduct of StudiesPart III - Technology Transfer, Protocol Development, and Sources of Funding Support for Research 28. Overview of Technology Development and Technology Transfer 29. Writing a Protocol 30. Evaluating a Protocol Budget 31. Clinical Research Data: Characteristics, Representation, Storage and Retrieval 32. Management of Patient Samples and Specimens 33. Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process 34. Clinical Research from the Industry Perspective 35. Philanthropy's Role in Advancing Biomedical ResearchPart IV - Clinical Research Infrastructure 36. Managing Clinical Risk