医薬品臨床試験実施基準ガイド：第3版

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

• The Phases of Clinical Study
• Clinical Trials Design and Analysis
• Corporate Implications of Non-compliance with GCP

• History of GCP Legislation
• Current Regulations
  • U.S.A
  • Canada
  • Japan

• Introduction
• The Principles of ICH GCP
• Standard Operating Procedures as Tools for GCP Compliance

• General Responsibilities of the Sponsor
• Contract Research Organization (CRO)?§312.52
  • Medical Expertise
  • Trial Design and Management
  • Investigator Selection and Assignment of Duties and Functions
  • Compensation and Financing
  • Submissions to Regulatory Authorities
  • Investigator' s Brochure (IB)
  • Investigational Drug Products
  • Record Access
  • Safety Information and Adverse Drug Effects Reporting
  • Annual Reports
  • Study Monitoring
  • Non-compliance
  • Premature Trial Termination or Suspension
  • Trial Reports
  • Regional Variations of Sponsor' s GCP Responsibilities

• Qualifications and Agreements
  • Communication with IRB
  • Investigational Drug Products
  • Informed Consent
  • Records and Reports
  • Progress Reports
  • Safety Reports
  • Final Investigator' s Report
• Common Technical Document Requirements
  • Premature Trial Termination or Suspension
  • Regional Variations of Investigator' s GCP Responsibilities

• Responsibilities
• Composition and Operations
• Review Procedures
• Subject Recruitment Advertising
• Informed Consent Form
• DHHS Regulations
• Records
• Regional Variations of IRB Duties and Responsibilities

• General Considerations
  • Brochure Contents

• General Information
• Background Information
• Study Purpose and Objectives
• Study Design
• Selection, Withdrawal, and Treatment of Subjects
• Assessments of Efficacy and Safety
• Statistical Analyses
• Other Provisions
• Data Handling and Record Keeping?Computerized Systems
• Protocol Amendments

• Introduction
• Before the Trial
• During the Clinical Phase
• After Completion or Termination

• Sponsor' s Monitoring
  • Selection and Qualification of Monitors
  • Extent and Nature of Monitoring
  • Monitor' s Responsibilities
    • Pre-investigation Visits
    • Visits During the Study
    • Study Follow-up Visits
  • Monitoring Reports
• Sponsor' s Study Audit
  • Purpose
  • Selection and Qualification of Auditors
  • Auditing Procedures
• Regulatory Inspections
  • Sponsor and Monitor Inspections
  • IRB Inspections
  • Investigator/site Inspections
• How to Cope with Audits and Inspections
• Before the Event
  • During the Inspection
  • After the Event
  • Regulatory follow-up Action and Sanctions

• Access to Regulatory Documents
• Guidelines to GCP
• Advisory Bodies, Publications and Web Sites
• Clinical Trial Management Companies and Consultants

• U.S.A. Code of Federal Regulations, Title 21
• Guidance for Industry Computerized Systems Used in Clinical Investigations
• Canada
• Japan
• New European Directives
• ICH Consolidated Guideline
• The Declaration of Helsinki

• Exhibit 2.1 Stages of Drug Development
• Exhibit 2.2 Drug Clinical Trial Phases
• Exhibit 2.3 Classification of Clinical Studies by Objectives
• Exhibit 3.1 Member Nations of the European Union
• Exhibit 3.2 Comparison of GCP Regulations and ICH Guidelines
• Exhibit 3.3 Consolidated Guideline, as Adopted by the Three ICH Regions
• Exhibit 4.1 The Clinical Trial Triangle
• Exhibit 4.2 SOP Form for a Laboratory Test
• Exhibit 4.3 SOP Form for a Procedure
• Exhibit 4.4 Minimum List of SOPs for a Clinical Study
• Exhibit 6.1 Diagram of the CTD
• Exhibit 6.2 Contents of CTD Clinical Summary Sections in Module 2
• Exhibit 6.3 Content of CTD Efficacy Section, Module 5
• Exhibit 8.1 Contents of an Investigator' s Brochure
• Exhibit 10.1 Essential Documents Required Before the Trial Starts
• Exhibit 10.2 Documents Generated During the Trial
• Exhibit 10.3 Documents to be Added After the Trial
• Exhibit 12.1 IRB Checklist
• Exhibit 12.2 Monitoring Visit Report
• Exhibit 12.3 CRF Review Form
• Exhibit 12.4 Source Data Verification Form
• Exhibit 12.5 Clinical Site Regulatory Binder Check List