Principles and Practice of Clinical Research

1. A Historical Perspective on Clinical Research Part I - Ethical, Regulatory and Legal Issues2. Ethical Principles in Clinical Research3. Integrity in Research: Principles for the Conduct of Research4. Institutional Review Boards5. 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 Trials8. Data and Safety Monitoring9. Unanticipated Risk in Clinical Research10. Legal Issues11. Inclusion of Women and Minorities as Subjects in Clinical Research12. Accreditation of Human Research Protection Programs13. The Role and Importance of Clinical Trials Registries14. The Clinical Researcher and the Media15. Clinical Research: A Patient Perspective Part II - Biostatistics and Epidemiology16. Design of Observational Studies 17. Design of Interventional Studies and Trials 18. Issues in Randomization19. Hypothesis Testing 20. Power and Sample Size Calculations21. An Introduction to Survival Analysis22. Intermediate Topics in Biostatistics23. Measures of Function and Health-Related Quality of Life24. Large Clinical Trials and Registries: Clinical Research Institutes25. Meta-analysis of Clinical Trials26. Using Large Datasets for Population-based Health Research27. Development and Conduct of Studies Part III - Technology Transfer, Protocol Development, and Sources of Funding Support for Research28. Overview of Technology Development and Technology Transfer29. Writing a Protocol30. Evaluating a Protocol Budget31. Clinical Research Data: Characteristics, Representation, Storage and Retrieval32. Management of Patient Samples and Specimens33. Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process34. Clinical Research from the Industry Perspective35. Philanthropy's Role in Advancing Biomedical Research Part IV - Clinical Research Infrastructure36. Managing Clinical Risk and Measuring Participants' Perceptions of the Clinical Research Process37. Clinical Pharmacology and its Role in Pharmaceutical Development 38. Career Paths in Clinical Research39. Clinical Research Nursing: A New Domain of Practice40. Issues and Challenges for Clinical Research in International Settings 41. The Role of Comparative Effectiveness Research42. The Importance and Use of Electronic Health Records in Clinical Research43. Informational Resources for the Clinical Researcher