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SUMMARY
D&MD's Guide to Good Clinical Practice, 3rd Edition updates the regulations
and their respective amendments since the 2nd edition was published in 2005.
The guide details the duties of the sponsors, institutional review boards
(IRB), investigators, and trial monitors. Practical advice is given on the
various mandates for achieving GCP compliance. The templates of forms for
study audits, data integrity checks and IRB operations are included for the
reader's access.
TABLE OF CONTENTS
Chapter 1: Executive Summary
Chapter 2: Introduction
- The Phases of Clinical Study
- Clinical Trials Design and Analysis
- Corporate Implications of Non-compliance with GCP
Chapter 3: International Regulations Governing GCP
- History of GCP Legislation
- Current Regulations
Chapter 4: The Elements of GCP Compliance
- Introduction......
- The Principles of ICH GCP
- Standard Operating Procedures as Tools for GCP Compliance
Chapter 5: The Sponsor?Duties and Responsibilities
- General Responsibilities of the Sponsor
- Contract Research Organization (CRO)?
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