Good clinical practice ( GCP ) is a set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with GCP assures patients and the public that the rights, safety and wellbeing of people taking part in studies are protected and that research data is reliable.
- Presents details on Good Clinical Practice (GCP), the international ethical, scientific, and practical standard to which all clinical research is conducted.
- Provides the most up-to-date and best practices, techniques, and methodologies in good clinical practice.
- Discusses applicable laws and regulations supporting GCP compliance, quality and operations.
- Diverse audience including clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics.
- Describes who is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted, and data are generated, documented, and reported in compliance with the protocol.
Preface
About the Editor
List of Contributors
Introduction
1 Regulatory Application Requirements
Shanthi Ganeshan and Connie Freund
2 An overview of Good Clinical Practices
John Klein and Sonya Edgerton
3 Quality by Design, Critical to Quality Factors - ICH E8 (R1)
Sam Sather and Jennifer Lawyer
4 Good Clinical Practice ICH E6 (R2 and R3)
John Klein and Sonya Edgerton
5 Clinical Safety Data Management ICH E2A
Karen Truhe
6 21 CFR 50 – Informed Consent
Joe Near
7 21 CFR 54 – Financial Disclosure
Glenda Guest
8 21 CFR 56 – Institutional Review Boards
Aurea Flores
9 Protected Health Information and Privacy in Clinical Trials (HIPAA)
Sam Sather
10 Good Pharmacovigilance Practices (GVP)
Jessica Chu
11 Data Integrity and 21CFR11 for GCPs
Randall Basinger
12 Preparing for FDA inspections at sponsor/investigator sites
Tommy Lee and Sam Sather
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, 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).
