Authoring High-quality Clinical Research Protocols

By Gregory P. Cuppan and McCulley/Cuppan Inc.

Authoring High-Quality Clinical Research Protocols is the first comprehensive guide dedicated to the craft of protocol writing. While most texts on clinical research focus on trial design or statistical methods, this book addresses the critical but under-taught skill of transforming study concepts into clear, precise, and usable protocol documents.

Drawing on real-world examples, the book demonstrates how information design principles-focus, logic, organization, and lean writing-directly impact readability, compliance, and study execution. Chapters include writing guidance, critiques of flawed protocol excerpts, optimized rewrites, and "What to notice" commentaries that train readers of the book to diagnose and resolve common writing problems.

Designed as both a desk-side reference and a teaching text, Authoring High-Quality Clinical Research Protocols is ideally suited for industry training and onboarding programs, graduate programs, investigator training, and hospital research offices. The book equips clinical research professionals with the tools to produce protocols that not only meet regulatory standards but also support reliable study conduct.

Key features include:
- Practical guidance aligned with ICH E6, ICH M11, and GCP standards
- Coverage of structured authoring, plain language, and machine readability

• Format: Paperback
• Language: English
• ISBN: B0FNK5NX3T
• ISBN13: 9798298858830
• Release Date: September 2025
• Publisher: Independently Published
• Length: 262 Pages
• Weight: 0.78 lbs.
• Dimensions: 0.6" x 6.0" x 9.0"