01/29/2025
In November 2024, the CRC press published the first edition of “Good Clinical Practices in Pharmaceuticals” edited by Graham P. Bunn (President of GB Consulting, LLC) and authored by multiple clinical trial professionals, including Clinical Pathways’ own Jennifer Lawyer and Sandra “Sam” Sather. The book is a compendium of information regarding the Good Clinical Practice (GCP) guidelines including the standards, methodologies, laws, and regulations. The principles of GCP originate from the International Conference of Harmonization (ICH) guidelines that are internationally recognized as the highest standard of ethical and scientific quality for designing, conducting, recording, and reporting trials that involve human subjects. The book was developed within a series titled “Drugs and the Pharmaceutical Sciences” which is intended to be a knowledge resource for pharmaceutical scientists to stay informed on the latest changes, innovations, and advances within the pharmaceutical ecosystem.
Compliance with GCP is essential to ensuring the protection of trial participant’s right, safety, and wellbeing while maintaining a level of data integrity that is considered reliable enough to base future studies off. The book contains 13 chapters, each covering a different component of GCP:
FDA Submission Requirements
Principles of GCP
Quality by Design, Critical to Quality Factors – ICH E8(R1)
Good Clinical Practice – Modernizing ICH E6
Good Clinical Safety Practice
Informed Consent
Financial Disclosure by Clinical Investigators
Institutional Review Boards
Protected Health Information and Privacy in Clinical Trials
Good Pharmacovigilance Practices (GVP)
Electronic Records; Electronic Signature and Data Integrity
Preparing for FDA Inspection at the Sponsor
Regulations Relating to the Placebo Response in Clinical Research
Abstracts of each chapter can be found here, and copies in either hardback or eBook format are available for purchase here. Jennifer and Sam are the authors of chapter 3: Quality by Design, Critical to Quality Factors – ICH E8(R1), chapter 9: Protected Health Information and Privacy in Clinical Trials, and coauthors of chapter 4: Good Clinical Practice – Modernizing ICH E6 and chapter 12: Preparing for FDA Inspection at the Sponsor. Both Sam and Jennifer are subject matter experts in each of these areas and, in the words of the editor; “bring many years of expertise, and have taken time from their busy schedules to share this with you, the reader, and are passionate about what they do”. Their depth of knowledge and passion for clinical trial consulting and training is reflected in the services offered at Clinical Pathways (see our related courses to the chapters mentioned above: 3, 4, 9, 12).
Clinical Pathways is currently updating their training courses in order to address the recent changes with the ICH adoption on ICH E6(R3) (see our previous blog for more information regarding R3, and keep an eye out for our new GCP: ICH E6(R3) training course). For a full list of our training and consulting services and to sign up for our blog and newsletter, please visit our website at https://www.clinicalpathwaysresearch.com/catalog.
The Clinical Pathways Team
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