Principles and Practice of Clinical Trial Medicine

Section I: Overview <br> <br> Chapter 1 Overview of Clinical Research Medicine<br> <br> Chapter 2 Ethical, Legal, and Regulatory Issues<br> <br><br>Section II: The General Structure of Clinical Trials and Programs<br><br> Chapter 3: Introduction to Clinical Trial Statistics<br> <br> Chapter 4: Measures and Variables<br> <br> Chapter 5: Study Groups<br> <br> Chapter 6: Periods, Sequences, and Trial Design<br> <br><br>Section III: Key Components of Clinical Trials and Programs<br><br> Chapter 7: Endpoints <br> <br> Chapter 8: Economics and Patient Reported Outcomes<br> <br> Chapter 9: Patient Selection and Sampling<br> <br> Chapter 10: Dosing and Intervention<br> <br> Chapter 11: Epidemiology, Decision Analysis, and Simulation <br> <br><br>Section IV: Conduct of the Study <br> <br> Chapter 12: Study Execution<br> <br> Chapter 13: Site Selection and Patient Recruitment <br> <br> <br> <br>Section V: Analysis of Results <br><br> Chapter 14 Assessing Data Quality and Transforming Data<br> <br> Chapter 15 Analysis of Data <br> <br> Chapter 16 Data Interpretation and Conclusions<br> <br><br>Concluding Remarks and Future Directions <br> <br>Appendices <br> Appendix A: FDA Internal Compliance Manuals<br> Appendix B: Medwatch Form <br> Appendix C: Sample Investigator’s Brochure <br> Appendix D: Sample Case Report Form <br> Appendix E: Sample Investigational New Drug Application Form <br> Appendix F: Statement of Investigator Form<br> Appendix G: SAE/SUSAR Initial Report Form