Good Clinical Practice: A Question and Answer Guide2024/2025 Edition - 1

Introduction
Welcome to the 2024/2025 edition of the Good Clinical Practice Question and Answer Guide. We are in
unprecedented times in the world of clinical research. We are coming out of a pandemic which has changed how
we conduct and manage clinical trials, and we are dealing with an unstable world where research subjects are
living in war torn regions. In this edition we have added several new chapters to address this ever-changing clinical
research environment. The pandemic made it clear that we could not continue with our traditional approach to
recruiting local patients to participate in a trial where they visited their physician's office on a regular basis for
participation in the trial.
Decentralized Clinical Trials (DCT) is one of the latest buzz words in the industry and organizations are
attempting to navigate this new approach to conducting clinical trials. We have included a chapter on this topic in
an effort to provide clarity on current regulatory thinking on this. Diversity, Equity, and Inclusion (DEI) is in all
aspects of our life and clinical research is no different. In order to successfully recruit a global representation of our
patient population, DEI must be a cornerstone of patient recruitment.
In the past several years we have seen the release of many new regulations and guidance throughout the world.
The book has been reorganized with added topics to meet this new era of clinical research. While we have removed
the regional references at the end of the book, we have integrated global regulatory requirements into each chapter
to represent our global efforts in drug development. Last year ICH released a draft version of revision 3 to E6. The
revisions of R3 Draft build on the introduction of the risk-based approach to conducting a clinical trial. While R3
has not been finalized, we do not anticipate major changes with the final version.
This reference guide, designed for the clinical researcher, categorizes commonly asked questions and answers
regarding Good Clinical Practice standards into 21 different areas, ranging from clinical monitoring to investigators/
sites, from source data/documentation to quality assurance activities/study auditing/FDA inspections, and from
Part 11/electronic clinical trials to informed consent. It is important to note that this reference guide addresses GCP
as it applies to clinical research on humans. It does not discuss GCP as it might apply to the practice of medicine
or nursing, to health care administration, to veterinary or non-clinical studies, or to non-US laws or customs.
Additionally, this reference guide is not intended to provide specific regulatory or legal advice. Readers should
consult their own company's standard operating procedures (SOPs), clinical and regulatory departments, and legal
counsel for guidance when applying GCP standards in clinical research.
We ask that in using this text, readers keep in mind that many areas lack an absolute consensus in approach,
and that there is no perfect knowledge of GCP. After all, GCP is a complicated, evolving discipline that intersects
with several other complex and evolving disciplines, including ethics, medicine and nursing, health systems,
regulatory, administrative and case law, management science, information technology, biostatistics, risk analysis,
public health, and health policy. Reasonable GCP practitioners with varied backgrounds can, and sometimes do,
disagree about how best to interpret and implement GCP standards and guidelines. We fully anticipate that not all
readers will agree with every answer provided in this reference guide. Put simply, we could not have endeavored
to provide meaningful answers without assuming such a risk. It is our hope, however, that this work can spark new
discussions or further existing dialogue that will, in the end, lead to more clarity and consensus in those areas in
which they are so badly needed.
Finally, in the 2024/2025 edition of the book, we have once again used the advice of our Expert Advisory
Panel. This panel consists of GCP and clinical experts from around the world who have assisted in the review and
evaluation of questions and answers contained in several sections of this book. A list of the names of the expert
panel is included below. As you will see, many of them are working in patient care and front-line roles during
the pandemic, and we are extremely grateful for their contributions during this unprecedented and challenging
time. We wish to thank those colleagues who took the time and made the effort to compose and submit questions
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Good Clinical Practice: A Question and Answer Guide2024/2025 Edition

Table of Contents for the Digital Edition of Good Clinical Practice: A Question and Answer Guide2024/2025 Edition