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Clinical trials handbook : design and conduct /
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Baltimore, MD :
Wiley,
©2013.
|
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- I. General
- 1. Terminology
- 2. Definitions
- 3. Measurement units
- 4. Trial type
- 5. Design and flow schematics
- 6. Design and operating principles
- 7. Counting and analysis rules
- 8. Multi-study umbrella name
- 9. Study name
- II. Design Specifications
- 10. Objective
- 11. Specific aims
- 12. Experimental variable
- 13. Treatment unit
- 14. Primary outcome
- 15. Outcome measures
- 16. Design synopsis
- III. Funding
- 17. Type of funding initiative
- 18. Funding: Specifications
- 19. Funding: Terminology
- 20. Funding: Type
- 21. Funding: Initiative
- 22. Funding: Period
- 23. Funding: Budget
- 24. Funding: Mode
- IV. Treatment Groups/Treatment Administration
- 25. Study groups
- 26. Comparison group
- 27. Study treatments
- 28. Test treatments
- 29. Control/comparison treatment
- 30. Placebo treatment
- 31. Sham treatment
- 32. Treatment modality
- 33. Treatment schedule
- 34. Treatment compliance measures
- 35. Protocol overrides
- 36. Protocol bailouts
- V. Masking
- 37. Mask/masking: Definitions
- 38. Masking principles
- 39. Masking, censoring, and shielding specifications
- 40. Drug masking procedure
- 41. Drug packaging and labeling
- 42. Drug supply
- 43. Masking safeguards
- 44. Unmasking treatment assignment
- 45. Results blackouts
- VI. Bias and Variance Control
- 46. Bias control procedures
- 47. Stratification
- 48. Variance control procedures
- 49. Separations
- VII. Treatment Assignment/Randomization
- 50. Assignment methods: Fixed vs. adaptive
- 51. Treatment assignment: Random vs. nonrandom
- 52. Randomization: Complete vs. restricted
- 53. Randomization unit
- 54. Randomization: Procedures
- VIII. IRBs and Consents
- 55. IRBs
- 56. IRBs: Models and procedures
- 57. Consent
- 58. Consent: Checklist
- 59. Consent: Disclaimers and notifications
- 60. Consent: Principles and purpose
- 61. Consent: Process
- 62. Consent: Types
- 63. Consent: Questions and answers
- IX. Enrollment and Followup
- 64. Notation
- 65. Timing conventions
- 66. Required approvals, permissions, accesses, and supplies
- 67. Start-up design
- 68. Start-up checklist
- 69. Recruitment design
- 70. Enrollment goals
- 71. Enrollment quotas
- 72. Followup: Terminology
- 73. Followup: Method
- 74. Followup: Length
- 75. Closeout design
- 76. Missed visit
- 77. Dropout
- 78. Loss to followup
- 79. Study timetable
- 80. Critical event path analysis
- 81. Eligibility criteria
- 82. Exclusions from enrollment
- 83. Eligibility and exclusions by reason
- X. Sample Size
- 84. Sample size: Design
- 85. Sample size: Specifications
- 86. Sample size: Calculation
- 87. Fixed vs. sequential sample size designs
- 88. Fixed vs. adaptive designs
- 89. Designed subgroup comparisons
- XI. Data Collection and Processing
- 90. Contact schedule
- 91. Examinations/visits
- 92. Examination/clinic visit schedule
- 93. Data collection
- 94. Data collection: Schedules and procedures
- 95. Data flow
- 96. Data processing procedures
- 97. Laboratory tests
- 98. Readings
- 99. Tissue repositories
- 100. Form design: Principles and procedures
- 101. Time window specifications
- 102. Data entry design
- 103. Data sharing: Internal
- 104. Data sharing: External
- XII. Study Centers
- 105. Center types
- 106. Centers
- 107. Center requirements
- XIII. Investigators/Study Staff
- 108. Investigator requirements
- 109. Clinic staffing requirements
- 110. Research group/Investigators
- XIV. Committees
- 111. Key Committees
- 112. Standing and working committees
- 113. Committee rules and procedures
- 114. Study officers
- 115. Study chair/vice-chair
- 116. Executive committee
- 117. Executive committee members
- 118. Steering committee
- 119. Steering committee members
- 120. Steering committee: Questions, answers, and observations
- 121. Steering committee representation models
- XV. Treatment Effects Monitoring
- 122. Treatment effects monitoring
- 123. Treatment effects monitoring: Purpose
- 124. Treatment effects monitoring: Approach
- 125. Treatment effects monitoring: Masking
- 126. Stopping rules and guidelines
- 127. Treatment effects monitoring: Questions and answers
- 128. Treatment effects monitoring committee
- 129. Treatment effects monitoring committee: Questions and answers
- XVI. Quality Control and Assurance
- 130. Quality control and assurance procedures
- 131. Performance monitoring
- 132. Training procedures
- 133. Assurances and certifications
- 134. Site visiting procedures
- 135. Audit procedures
- XVII. Data Analysis
- 136. Analysis datasets
- 137. Analysis questions regarding study results publications
- 138. Frequentist vs. Bayesian analysis
- 139. Final analysis
- 140. Subgroup analysis
- XVIII. Publication/Presentation
- 141. Publication
- 142. Publication policy
- 143. Authorship
- 144. Credits
- 145. Presentation policy
- XIX. Policies
- 146. Policies
- 147. Publicity policy
- 148. Policy on access to study documents
- 149. Policy on access to study data and results
- 150. Policy on advertising for patients
- 151. Policy on incentive payments
- 152. Policy on payment of patient-related travel expenses
- 153. Ancillary study policy
- 154. Policy on patient-care-related payments
- 155. Policy on conflicts of interest
- 156. Substudy policy
- XX. Adverse Events
- 157. Adverse events
- 158. Adverse event reporting procedures
- XXI. Miscellaneous
- 159. Key study documents
- 160. Design synopsis
- 161. Slide sets
- 162. Study CV
- 163. Study website
- 164. Study history log
- 165. Landmark events and dates
- 166. Registration.