Good Clinical Practice: A Question & Answer Reference Guide 2007

Edited by Mark P. Mathieu
PAREXEL International Corporation

This publication is packed with informative and well-researched answers to important questions frequently raised by professionals engaged in all aspects of clinical research. As with previous editions of this guide, the fifth edition focuses on applying broad good clinical practice (GCP) standards to the real world settings of human clinical trials research. The questions and answers are categorized into 22 areas ranging from GCP regulations, standards and guidelines, informed consent and drug/study safety to quality assurance activities, drug accountability and fraud, negligence, and regulatory non-compliance. Contributing authors representing all areas of clinical research including industry, FDA experts, clinical associates, quality assurance auditors, clinical trainers, attorneys, study investigators and field inspectors provide targeted and informed answers to challenging and critical issues impacting this field.

TTo provide further clarification on current global activities in the clinical research profession, the fifth edition examines GCP and clinical research standards in the EU and reviews the state of clinical practice in the following emerging countries:

Device manufacturers are eligible to participate in the PMAP if they comply with the following requirements:

• India
• Russia
• Japan
• Canada
• China NEW!

Additional areas addressed in this publication include pharmacogenetic testing, possible conflict-of-interest disclosures, Part 11 and electronic clinical trials, and the Privacy Rule and its implications for clinical research.

The appendix contains the following complete updated texts:

• Title 21 CFR Part 11 (Electronic Records; Electronic Signatures)
• Title 21 CFR Part 50 (Protection of Human Subjects)
• Title 21 CFR Part 54 (Financial Disclosure by Clinical Investigators)
• Title 21 CFR Part 56 (Institutional Review Boards)
• Title 21 CFR Part 312 (Investigational New Drug Applications)
• ICH Guideline for Good Clinical Practice
• ICH Guideline - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

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Table of Contents:

Section 1: GCP Regulations, Standards and Guidelines for Clinical Research
Section 2: Investigators/Sites
Section 3: Form FDA-1572/Statement of the Investigator
Section 4: Clinical Monitoring
Section 5: Informed Consent
Section 6: Source Data/Documentation
Section 7: Clinical Trials Protocols/Protocol Changes/Protocol Violations
Section 8: Institutional Review Boards
Section 9: Drug/Study Safety and Safety Reporting
Section 10: Quality Assurance Activities/Study Auditing/FDA Inspections
Section 11: Computerized Systems, e-Clinical Trials, and Part 11
Section 12: Patient Recruitment
Section 13: Conflicts of Interest/Financial Disclosure
Section 14: HIPAA and Commercial Clinical Research
Section 15: Drug Accountability, Administration and Labeling
Section 16: Fraud, Negligence, and Regulatory Non-Compliance
Section 17: Subject Diaries
Section 18: State Laws Affecting Clinical Trials
Section 19: GCP and Clinical Trial Research Standards in the EU
Section 20: Clinical Trial and GCP Standards in the Selected Leading Countries: Russia, India, Japan, Canada and China