Guide to Good Clinical Practice, 3rd Edition

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