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
• Clinical Programmers
• Clinical Statisticians
What's the Price?
• 1-249 copies: $17.95 • 250-499 copies: $16.95
• 500-749 copies: $15.95 • 750+ copies: $14.95
Custom Cover Prices*?
• 1-24 copies: unavailable • 25-100 copies: $2.00/book
• 100-249 copies: $1.00/book • 250+ copies: No charge
* Based on quantities of a single book title
• ICH GUIDELINES (US-adopted versions)
• Structure and Content of Clinical Study Reports (ICH- E3)
• Questions and Answers (R1) on ICH E3: Structure and
Content of Clinical Study Reports
• Statistical Principles for Clinical Trials (ICH - E9)
