Good Clinical Practice: A Question & Answer Reference Guide 2026/2027
A comprehensive, practice-focused GCP reference used by clinical research professionals to interpret and apply global GCP standards in real-world trial environments.
For decades, Good Clinical Practice: A Question & Answer Reference Guide has served as a trusted resource for navigating the practical application of GCP. Rather than restating regulations, the guide addresses the real questions that arise during trial execution, oversight, and inspection readiness — especially where guidance is open to interpretation.
The 2026/2027 edition reflects how GCP expectations are being evaluated today, across increasingly complex and global clinical trials.
Editor-in-Chief: Donna W. Dorozinsky, RN, MSN, CCRC, Founder & CEO, Just In Time GCP
- Courtney Bryant, MBA, Vice President, Program Management, QurAlis
- Nikki Christison, BS, CCRA, IACR, Principal, Clinical Resolutions
- Keith Dorricott, BSc, MBB, Director, Dorricott Metrics & Process Improvement Ltd.
- Deborah A. Guattery, BSN, MJ, RN, GCP Quality Expert, Chase the Sky for Quality
- Michael R. Hamrell, PhD, RAC, FRAPS, CCRA, FRACP, RQAP-GCP, MORIAH Consultants (former Editor-in-Chief)
- Jonathan Heinemann, Executive Director, Clinical Quality Assurance, INHIBRx, Inc.
- Joseph G. Iacobucci RPh MBA, Principal, Integrated Clinical Supplies LLC
- Trish Landry, MBA, RAC, CCRP, Sr. Vice President, Beaufort CRO
- Susan M. Leister, MBA, PhD, CQA, CSSBB, Vice President, Quality & Compliance, TRI, Inc.
- Avery Miles, Director, Privacy, Quest Diagnostics
- Heather Murphy, RN, MBA, CQA, Founder and CEO, HMGlobal Pharmacovigilance Consulting, LLC
- Anastassia Negrouk, Chief Operating Officer, MyData-Trust
- Elizabeth Ronk Nelson, MPH, President, Regulatory Risk Management
- Dawn Niccum, RN/MSN, RQAP, CCRA, PMP, Executive Vice President, Q&A Compliance, InSeption
- Alberto Pacheco, Independent Consultant
- Denise G. Redkar-Brown, MT., Independent Consultant
- Sharon S. Reinhard, MS, Independent Quality Consultant
- Leslie Sam, BA, CQIA, CSSBB, President, Leslie Sam and Associates, LLC
- Editor Emeritus: Mark Mathieu, PAREXEL International Corporation
Some highlights of the completely updated guide include:
- An authoritative Q&A reference for applying GCP in practice, addressing the full scope of modern GCP expectations
- Grounded in real-world experience and expert perspectives
- Designed to support oversight, accountability, and inspection readiness
The publication is a working reference — not a training manual or checklist! Order your copy today!
