Overview

Good clinical practice (GCP) is a set of internationally recognized 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 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. 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.

Full Product Details

Author:   Graham P. Bunn (GB Consulting LLC, in Pennsylvania, USA)
Publisher:   Taylor & Francis Ltd
Imprint:   CRC Press
ISBN:  

9781032524078

ISBN 10:   1032524073
Pages:   194
Publication Date:   26 November 2024
Audience:   College/higher education ,  Professional and scholarly ,  Postgraduate, Research & Scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Forthcoming
Availability:   Not yet available  
This item is yet to be released. You can pre-order this item and we will dispatch it to you upon its release.

Table of Contents

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

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Author Information

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).

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