| 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.
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- 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
- U.S.A
- Canada
- Japan
- 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)—ยง312.52
- 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
- Chapter 6: The Clinical Investigator—Duties and 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
- Chapter 7: The Institutional Review Board/Independent Ethics Committee (IRB/IEC)
- Responsibilities
- Composition and Operations
- Review Procedures
- Subject Recruitment Advertising
- Informed Consent Form
- DHHS Regulations
- Records
- Regional Variations of IRB Duties and Responsibilities
- Chapter 8: The Investigator’s Brochure
- General Considerations
- Brochure Contents
- Chapter 9: The Clinical Trial Protocol
- 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
- Chapter 10: Essential Documents for Trial Conduct
- Introduction……
- Before the Trial…
- During the Clinical Phase
- After Completion or Termination
- Chapter 11: Internal and External Monitoring and Inspections
- 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
- Chapter 12: Checklists and Forms for Monitoring and Audits
- Chapter 13: References and Further Reading
- Access to Regulatory Documents
- Guidelines to GCP
- Advisory Bodies, Publications and Web Sites
- Clinical Trial Management Companies and Consultants
- Chapter 14: Text of Regulations and Guidelines
- 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
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