1

Your cart is empty.



Celebrating 22 YEARS of Regulatory Excellence!
Go with the Most-Trusted Regulations & Guidelines Books on the Market.


Now Taking Advance Orders for our Revised APRIL 1, 2024 Books!      Also check out our NEW Book:  Good Clinical Practice Regulations in the US & the EU  (Book 1C)!

Book 13:  2024 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials (Copy)

Book 13: 2024 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials (Copy)

$ 17.95

Return to Previous Page

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)