INTRODUCTION<br>1. Introduction<br>2. Translational Process<br>3. Scientific Method<br>4. Basic Research<br><br>PRE-CLINCIAL<br>5. Overview of Preclinical Research<br>6. What Problem are you Solving?<br>7. Types of Interventions<br>8. Drug discovery<br>9. Drug Testing<br>10. Device Discovery and Prototyping<br>11. Device testing<br>12. Other product types<br>13. Procedural Technique Development<br>14. Behavioral Intervention<br><br>CLINICAL: FUNDAMENTALS<br>15. Introduction to clinical research: What is it? Why is it needed?<br>16. Study population: Who and why them?<br>17. Outcome measurements: What data is being collected and why?<br><br>TATISTICAL PRINCIPLES<br>18. Common issues in analysis<br>19. Basic statistical principles<br>20. Distributions<br>21. Hypotheses and error types<br>22. Power<br>23. Regression<br>24. Continuous Variable Analyses: Student’s t-test, Rank-Sum Test, and Signed-Rank Test<br>25. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel<br>26. Analysis of variance<br>27. Correlation<br>28. Basic science statistics<br><br>CLINICAL: STUDY TYPES<br>29. Design principles: Hierarchy of study types<br>30. Case series: Design, measures, classic example<br>31. Case-control study: Design, measures, classic example<br>32. Cohort study: Design, measures, classic example<br>33. Cross-section study: Design, measures, classic example<br>34. Longitudinal Study: Design, measures, classic example<br>35. Clinical trials: Design, measures, classic example<br>36. Meta-analysis: Design, measures, classic example<br>37. Cost-Effectiveness Analysis: Design, Measures, and Classic Example<br>38. Database Research in Urology<br>39. Surveys and questionnaires: Design, measures, classic example<br>40. Qualitative methods and mixed methods<br><br>CLINICAL TRIALS<br>41. Randomized Controlled Trials: Design, Measures, and Classic Examples<br>42. Nonrandomized control: Design, measures, classic example<br>43. Historical control: Design, measures, classic example<br>44. Cross-over: Design, measures, classic example<br>45. Withdrawal Studies<br>46. Equivalence and noninferiority: Design, measures, classic example<br>47. Randomization: Fixed or adaptive procedures<br>48. Blinding: Who and how?<br>49. Multicenter considerations<br>50. Phases of Clinical Trials<br>51. Window of Opportunity, Phase 0 Trials<br>52. IDEAL Framework<br>53. Artificial Intelligence<br>54. Patient Perspectives<br><br>CLINICAL: PREPARATION<br>55. Sample Size<br>56. Budgeting<br>57. Ethics and review boards<br>58. Regulatory considerations for new drugs and devices<br>59. Funding approaches<br>60. Data management<br>61. Statistical Software<br>62. Subject adherence<br>63. Survival analysis<br>64. Monitoring committee in clinical trials<br><br>REGULATORY BASICS<br>65. FDA overview<br>66. IND<br>67. New drug application<br>68. Devices<br>69. Biologics<br>70. Combination Products<br>71. Foods<br>72. CMC and GxP<br>73. Post-Market Drug Safety Monitoring<br>74. Post-Market Device Safety Monitoring<br><br>CLINICAL IMPLEMENTATION<br>75. Implementation Research<br>76. Design and Analysis<br>77. Population- and Setting-Specific Implementation<br><br>PUBLIC HEALTH<br>78. Public Health<br>79. Epidemiology<br>80. Public Health Factors and Social Determinants of Health in Urological Research<br>81. Good Questions<br>82. Population- and Environmental-Specific Considerations<br>83. Healthcare Institutions and Systems<br>84. Public Health Institutions and Systems<br><br>Practical Resources<br>85. Presenting Data<br>86. Manuscript Preparation<br>87. Building a Team<br>88. Patent Basics<br>89. Venture Pathways<br>90. SBIR/STTR<br>91. Sample Forms and Templates