Full Description
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.
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
