Book 13: 2026 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials (Copy)Description Contents Cover This spiral bound, 5" x 7. 5" book contains the US adopted versions of the ICH Guidelines on writing clinical study reports and on statistical principles for clinical trials. It covers such topics as: Safety Evaluation Adverse Events Efficacy Evaluation Trial Design Considerations Data Analysis Who Uses this Book? Staff involved in writing and or reviewing clinical study reports Staff involved in protocol development