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- Title Pages
- Dedication
- Preface
- Acknowledgments
- Tables and figures
- Part I Introduction and current status
- 1 Introduction
- 2 Clinical trials: A state-of-the-art assessment
- 3 The activities of a clinical trial
- 4 Single-center versus multicenter trials
- 5 Coordinating and other resource centers in multicenter trials
- 6 Cost and related issues
- 7 Impact of clinical trials on the practice of medicine
- Part II Design principles and practices
- 8 Essential design features of a controlled clinical trial
- 9 Sample size and power estimates
- 10 Randomization and the mechanics of treatment masking
- 11 The study plan
- 12 Data collection considerations
- Part III Execution
- 13 Preparatory steps in executing the study plan
- 14 Patient recruitment and enrollment
- 15 Patient follow-up, close-out, and post-trial follow-up
- 16 Quality assurance
- Part IV Data analysis and interpretation
- 17 The analysis database
- 18 Data analysis requirements and procedures
- 19 Questions concerning the design, analysis, and interpretation of clinical trials
- 20 Interim data analyses for treatment monitoring
- Part V Management and administration
- 21 Funding the trial
- 22 Essential management functions and responsibilities
- 23 Committee structures of multicenter trials
- Part VI Reporting procedures
- 24 Study publication and information policies
- 25 Preparation of the study publication
- 26 Locating and reading published reports
- Part VII Appendixes
- A. Glossary
- B. Sketches of selected trials
- C. Year 1980 clinical trial publications1
- D. Activities by stage of trial
- E. Sample consent statements
- F. Data items and forms illustrations
- G. Sample manual of operations, handbook, and monitoring report
- H. Budget summary for Hypertension Prevention Trial Data Coordinating Center
- I. Combined bibliography
- Index
(p.374) E. Sample consent statements
(p.374) E. Sample consent statements
- Source:
- Clinical Trials
- Publisher:
- Oxford University Press
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- Title Pages
- Dedication
- Preface
- Acknowledgments
- Tables and figures
- Part I Introduction and current status
- 1 Introduction
- 2 Clinical trials: A state-of-the-art assessment
- 3 The activities of a clinical trial
- 4 Single-center versus multicenter trials
- 5 Coordinating and other resource centers in multicenter trials
- 6 Cost and related issues
- 7 Impact of clinical trials on the practice of medicine
- Part II Design principles and practices
- 8 Essential design features of a controlled clinical trial
- 9 Sample size and power estimates
- 10 Randomization and the mechanics of treatment masking
- 11 The study plan
- 12 Data collection considerations
- Part III Execution
- 13 Preparatory steps in executing the study plan
- 14 Patient recruitment and enrollment
- 15 Patient follow-up, close-out, and post-trial follow-up
- 16 Quality assurance
- Part IV Data analysis and interpretation
- 17 The analysis database
- 18 Data analysis requirements and procedures
- 19 Questions concerning the design, analysis, and interpretation of clinical trials
- 20 Interim data analyses for treatment monitoring
- Part V Management and administration
- 21 Funding the trial
- 22 Essential management functions and responsibilities
- 23 Committee structures of multicenter trials
- Part VI Reporting procedures
- 24 Study publication and information policies
- 25 Preparation of the study publication
- 26 Locating and reading published reports
- Part VII Appendixes
- A. Glossary
- B. Sketches of selected trials
- C. Year 1980 clinical trial publications1
- D. Activities by stage of trial
- E. Sample consent statements
- F. Data items and forms illustrations
- G. Sample manual of operations, handbook, and monitoring report
- H. Budget summary for Hypertension Prevention Trial Data Coordinating Center
- I. Combined bibliography
- Index
