Good Clinical Practice: A Question & Answer Reference Guide - May 2011 - (Page iii)

Table of Contents Introduction ...............................................................................................................................................................1 Section 1: GCP Regulations, Standards and Guidelines for Clinical Research ........................................................3 Section 2: Investigators/Sites ..................................................................................................................................33 Section 3: Form FDA-1572/Statement of the Investigator .....................................................................................91 Section 4: Study Sponsors and Clinical Trial Monitoring ....................................................................................119 Section 5: Informed Consent ................................................................................................................................149 Section 6: Source Data/Documentation ................................................................................................................223 Section 7: Clinical Trial Protocols/Protocol Changes/Protocol Violations ...........................................................261 Section 8: Institutional Review Boards .................................................................................................................275 Section 9: Drug/Study Safety and Safety Reporting.............................................................................................313 Section 10: FDA Inspections, Quality Assurance Activities, and Study Auditing................................................341 Section 11: Computerized Systems, e-Clinical Trials, and Electronic Records Rules .........................................389 Section 12: Patient Recruitment............................................................................................................................411 Section 13: Conflicts of Interest/Financial Disclosure..........................................................................................439 Section 14: The HIPAA Privacy Rule and FDA-Regulated Clinical Trials ..........................................................459 Section 15: Drug Accountability, Administration, and Labeling ..........................................................................479 Section 16: Fraud, Negligence, and Regulatory Non-Compliance .......................................................................487 Section 17: Subject Diaries ...................................................................................................................................503 Section 18: GCP and Clinical Research Standards in the European Union and An Interview with Fergus Sweeney, Ph.D., EMA Head of Sector, Compliance and Inspection. .................507 Section 19: Clinical Trial and GCP Standards in Selected Leading Countries/Regions: Latin America, China, Russia, and India ......................................................................................................541 Section 20: GCP Compliance Statistics and Trends .............................................................................................579 Appendices 21 CFR Part 11 — Electronic Records; Electronic Signatures ...............................................................591 21 CFR Part 50 — Protection of Human Subjects ..................................................................................597 21 CFR Part 54 — Financial Disclosure by Clinical Investigators .........................................................611 21 CFR Part 56 — Institutional Review Boards .....................................................................................617 21 CFR Part 312 — Investigational New Drug Application ...................................................................629 ICH Consolidated Guideline on Good Clinical Practice (E6) .................................................................669 ICH Guideline on Clinical Safety Data Management (E2A) ..................................................................717 European Union Clinical Trials Directive ...............................................................................................731 European Union Good Clinical Practice Directive..................................................................................743 iii

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2011

Good Clinical Practice: A Question & Answer Reference Guide - May 2011
Table of Contents
Introduction
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: Study Sponsors and Clinical Trial Monitoring
Section 5: Informed Consent
Section 6: Source Data/Documentation
Section 7: Clinical Trial Protocols/Protocol Changes/Protocol Violations
Section 8: Institutional Review Boards
Section 9: Drug/Study Safety and Safety Reporting
Section 10: FDA Inspections, Quality Assurance Activities, and Study Auditing
Section 11: Computerized Systems, e-Clinical Trials, and Electronic Records Rules
Section 12: Patient Recruitment
Section 13: Conflicts of Interest/Financial Disclosure
Section 14: The HIPAA Privacy Rule and FDA-Regulated Clinical Trials
Section 15: Drug Accountability, Administration, and Labeling
Section 16: Fraud, Negligence, and Regulatory Non-Compliance
Section 17: Subject Diaries
Section 18: GCP and Clinical Research Standards in the European Union and An Interview with Fergus Sweeney, Ph.D., EMA Head of Sector, Compliance and Inspection
Section 19: Clinical Trial and GCP Standards in Selected Leading Countries/Regions: Latin America, China, Russia, and India
Section 20: GCP Compliance Statistics and Trends
21 CFR Part 11 — Electronic Records; Electronic Signatures
21 CFR Part 50 — Protection of Human Subjects
21 CFR Part 54 — Financial Disclosure by Clinical Investigators
21 CFR Part 56 — Institutional Review Boards
21 CFR Part 312 — Investigational New Drug Application
ICH Consolidated Guideline on Good Clinical Practice (E6)
ICH Guideline on Clinical Safety Data Management (E2A)
European Union Clinical Trials Directive
European Union Good Clinical Practice Directive

Good Clinical Practice: A Question & Answer Reference Guide - May 2011