Good Clinical Practice: A Q&A Reference Guide

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.

Editorial Leadership

This edition is edited by Donna Dorozinsky, Founder & CEO of Just in Time GCP, bringing inspection-informed perspective to one of the industry’s most relied-upon GCP references.

Her editorial leadership emphasizes how GCP is:

Interpreted by regulators
Applied in day-to-day trial execution
Evaluated during inspections

This edition reflects how GCP expectations are assessed across sponsors, sites, vendors, and systems.

What this Guide is

An authoritative Q&A reference for applying GCP in practice
Grounded in real-world experience and expert perspective
Designed to support oversight, accountability, and inspection readiness

This is a working reference — not a training manual or checklist.

What it Covers

The guide addresses the full scope of modern GCP expectations. Table of contents listed below.

GCP Regulations, Standards, and Guidelines
Investigators/Sites
Investigator Site Oversight
Informed Consent
Clinical Trial Protocols/Protocol Changes/Protocol Violations
Institutional Review Boards (IRBs) and Ethics Committees
Clinical Trial and Postmarketing Safety
Quality Assurance and Auditing
Regulatory Inspections
Clinical Data Management
Computerized Systems, Electronic Records, and e-Data Integrity
Patient Recruitment and Clinical Trial Diversity

Conflicts of Interest/Financial Disclosure
Investigational Medicinal Product Management
Non-Compliance, Misconduct, and Root Cause Management
The Trial Master File (TMF)
Risk-Based Quality Management/Quality by Design
Impact of World Events on Clinical Trial Management
Decentralized Clinical Trial Elements (Performing a Clinical Trial Outside of a Traditional Clinical Trial Site)
European Privacy and Data Protection/GDPR
Vendor Oversight and Third-Party Risk Management
Data Transparency and Disclosures
GCP Compliance Statistics and Trends

Expert Contributors with Real-World GCP Experience

This guide is shaped by experts with deep experience in clinical operations, quality, regulatory compliance, and inspection readiness across global trials. Check out the editorial team and expert advisory panel listed below.

Editor-in-Chief: Donna W. Dorozinsky, RN, MSN, CCRC, Founder & CEO, Just In Time GCP
Editor Emeritus: Mark Mathieu, PAREXEL International Corporation
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

Who it's For

Designed for sponsors, clinical operations, quality, and compliance professionals who need practical guidance on how GCP expectations are interpreted and evaluated in practice.