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. Diagnostic discovery<br>13. Diagnostic testing<br>14. Other product types<br>15. Procedural technique development<br>16. Behavioral intervention<br><br>CLINICAL: FUNDAMENTALS<br>17. Introduction to clinical research: What is it? Why is it needed?<br>18. The question: Types of research questions and how to develop them<br>19. Study population: Who and why them?<br>20. Outcome measurements: What data is being collected and why?<br>21. Optimizing the question: Balancing significance and feasibility<br><br>STATISTICAL PRINCIPLES<br>22. Common issues in analysis<br>23. Basic statistical principles<br>24. Distributions<br>25. Hypotheses and error types<br>26. Power<br>27. Regression<br>28. Continuous variable analyses: t-test, Man Whitney, Wilcoxin rank<br>29. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel<br>30. Analysis of variance<br>31. Correlation<br>32. Biases<br>33. Basic science statistics<br><br>CLINICAL: STUDY TYPES<br>34. Design principles: Hierarchy of study types<br>35. Case series: Design, measures, classic example<br>36. Case-control study: Design, measures, classic example<br>37. Cohort study: Design, measures, classic example<br>38. Cross-section study: Design, measures, classic example<br>39. Longitudinal study: Design, measures, classic example<br>40. Clinical trials: Design, measures, classic example<br>41. Meta-analysis: Design, measures, classic example<br>42. Cost-effectiveness study: Design, measures, classic example<br>43. Diagnostic test evaluation: Design, measures, classic example<br>44. Reliability study: Design, measures, classic example<br>45. Database studies: Design, measures, classic example<br>46. Surveys and questionnaires: Design, measures, classic example<br>47. Qualitative methods and mixed methods<br><br>CLINICAL TRIALS<br>48. Randomized control: Design, measures, classic example<br>49. Nonrandomized control: Design, measures, classic example<br>50. Historical control: Design, measures, classic example<br>51. Cross-over: Design, measures, classic example<br>52. Withdrawal studies: Design, measures, classic example<br>53. Factorial design: Design, measures, classic example<br>54. Group allocation: Design, measures, classic example<br>55. Hybrid design: Design, measures, classic example<br>56. Large, pragmatic: Design, measures, classic example<br>57. Equivalence and noninferiority: Design, measures, classic example<br>58. Adaptive: Design, measures, classic example<br>59. Randomization: Fixed or adaptive procedures<br>60. Blinding: Who and how?<br>61. Multicenter considerations<br>62. Registries<br>63. Phases of clinical trials<br>64. IDEAL Framework<br>65. Artificial Intelligence<br>66. Patient perspectives<br><br>CLINICAL: PREPARATION<br>67. Sample size<br>68. Budgeting<br>69. Ethics and review boards<br>70. Regulatory considerations for new drugs and devices<br>71. Funding approaches<br>72. Subject recruitment<br>73. Data management<br>74. Quality control<br>75. Statistical software<br>76. Report forms: Harm and Quality of Life<br>77. Subject adherence<br>78. Survival analysis<br>79. Monitoring committee in clinical trials<br><br>REGULATORY BASICS<br>80. FDA overview<br>81. IND<br>82. New drug application<br>83. Devices<br>84. Radiation-emitting electronic products<br>85. Orphan drugs<br>86. Biologics<br>87. Combination products<br>88. Foods<br>89. Cosmetics<br>90. CMC and GxP<br>91. Non-US regulatory<br>92. Post-Market Drug Safety Monitoring<br>93. Post-Market Device Safety Monitoring<br><br>CLINICAL IMPLEMENTATION<br>94. Implementation Research<br>95. Design and analysis<br>96. Mixed-methods research<br>97. Population- and setting-specific implementation<br><br>PUBLIC HEALTH<br>98. Public Health<br>99. Epidemiology<br>100. Factors<br>101. Good questions<br>102. Population- and environmental-specific considerations<br>103. Law, policy, and ethics<br>104. Healthcare institutions and systems<br>105. Public health institutions and systems<br>106. Presenting data<br>107. Manuscript preparation<br>108. Building a team<br>109. Patent basics<br>110. Venture pathways<br>111. SBIR/STTR<br>112. Sample forms and templates