Introduction- Vaska Tone
Chapter 1 FDA Submission Requirements
Shanthi Ganeshan and Connie Freund
Chapter 2 Principles of Good Clinical Practice (GCP)
John S. Klein and Sonya T. Edgerton
Chapter 3 Quality by Design, Critical to Quality Factors – ICH E8(R1)
Sandra “Sam” Sather and Jennifer Lawyer
Chapter 4 Good Clinical Practice – Modernizing ICH E6
John S. Klein, Sonya T. Edgerton, and Sandra “Sam” Sather
Chapter 5 Good Clinical Safety Practice
Karen Truhe
Chapter 6 Informed Consent
Joseph Near
Chapter 7 Financial Disclosure by Clinical Investigators
Glenda Guest
Chapter 8 Institutional Review Boards
Aurea Flores
Chapter 9 Protected Health Information and Privacy in Clinical Trials
Sandra “Sam” Sather
Chapter 10 Good Pharmacovigilance Practices (GVP)
Jessica Chu
Chapter 11 Electronic Records; Electronic Signature and Data Integrity
Randall Basinger
Chapter 12 Preparing for FDA Inspections at the Sponsor
Sandra “Sam” Sather, Tommy Lee, and Jennifer Lawyer
Chapter 13 Regulations Relating to the Placebo Response in Clinical Research
Graham Bunn and Arthur Ooghe
Biography
Graham P. Bunn has been the president of GB Consulting LLC, in Pennsylvania, since 2000 and provides regulatory compliance guidance and technical consulting services for pharmaceutical, biotechnology, and other FDA‑related industries. His experience includes supporting and leading teams for quality systems assessments, regulatory action responses and remediations (FDA483, Warning Letter, Consent Decree), and preparing sites to host regulatory inspections. He has developed and facilitated numerous highly interactive learning workshops worldwide, including Aseptic Training Programs, Batch Record Reviews, QA on the Floor, and aseptic training support for Compounding Centers. Before founding GB Consulting LLC, Graham gained extensive experience through various management positions in the pharmaceutical industry with SmithKline Beecham PLC (GlaxoSmithKline PLC), Wyeth Pharmaceuticals (Pfizer), and Astra Merck Inc. (AstraZeneca PLC). His career includes management responsibilities as a corporate compliance auditor, quality assurance, validation, and clinical trials manufacturing and packaging. Graham is the editor of Good Manufacturing Practices for Pharmaceuticals and Good Laboratory Practices for Non‑Clinical Studies and the author of several book chapters/journal articles. Graham received a BSc in pharmacy from Brighton University, England, and an MSc in Quality Assurance and Regulatory Affairs from Temple University, Philadelphia, and is a member of the Regulatory Affairs Professional Society (RAPS).
