Good Clinical Practice: A Question & Answer Reference Guide - May 2012 - (Page 5)

Section 1: GCP Regulations, Standards and Guidelines for Clinical Research 1.1 Q. Today, what regulations, guidances, and other documents are considered to comprise good clinical practice (GCP) in the United States? A. Traditionally, GCP has been a term of art used by those in U.S. government agencies, other regulatory authorities, industry, and clinical research to identify a collection of related regulations and guidelines that, when taken together, define the clinical study-related responsibilities of sponsors, clinical investigators, monitors, institutional review boards (IRB), and others involved in the clinical research process. For many years, these responsibilities were defined primarily in four documents released in the 1980s: • a 1981 regulation on the informed consent of clinical subjects (now 21 CFR Part 50); • a 1981 regulation on the responsibilities of IRBs (now 21 CFR Part 56); • the 1987 IND Rewrite regulations, which define the responsibilities of the investigator and the sponsor (now 21 CFR Part 312); and • the 1988 “Guideline for the Monitoring of Clinical Investigations,” which outlines the responsibilities of monitors. As a “living” standard and concept, however, GCP is continually being affected by evolving thought and standards. The most recent significant addition to the FDA’s corpus of GCP documents is the International Conference on Harmonization’s (ICH) “Good Clinical Practice: Consolidated Guideline,” which was adopted by the ICH parties in 1996 and then as an FDA guidance in May 1997. Designed to provide “a unified standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects,” this harmonized document provides guidance on IRB, sponsor, investigator, monitoring, and auditing requirements, and offers helpful guidance on the content and format of clinical protocols. Integrated into the consolidated ICH guideline are two additional guidelines that were originally issued as separate draft documents in 1994: “Guideline for the Investigator’s Brochure,” which specifies the minimum information required in, and recommends a format for, the investigator’s brochure; and “Guideline for Essential Documents for the Conduct of a Clinical Study,” which identifies the essential documents that “individually and collectively permit evaluation of the conduct of a clinical study and the quality of the data produced.” While these regulations and guidances continue to form the core of GCP today, several other FDA regulations and documents are also thought to fall under the rubric of GCP standards. These include FDA regulations on electronic records/signatures (Part 11), which are relevant to electronic clinical study records, and regulations on financial disclosures for clinical investigators (Part 54). More recently, the FDA released an April 2008 final regulation that has revised the agency’s standards for accepting, for research or marketing purposes, foreign clinical studies that are not conducted under an IND. Today, there is also an ever-growing number of guidance documents that support GCP. These guidances provide the FDA’s latest thinking on various aspects of GCP standards and what is necessary to meet these standards, and define the responsibilities of those involved in clinical research. Recently, for example, the FDA released an October 2009 guidance entitled, “Investigator Responsibilities—Protecting the Rights, Safety, and Welfare of Study Subjects” and a January 2009 guidance entitled, “Adverse Event Reporting to IRBs—Improving Subject Protections” (see Section 9). Other FDA guidance includes a set of documents called Information Sheets for Institutional Review Boards and Clinical Investigators and the FDA’s compliance program guidance manuals, which specify how FDA investigators ensure that clinical sponsors, monitors, institutional review boards, and clinical investigators comply with GCP. The information sheets have been updated and republished under the title, Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors— most of the current 25 guidances are dated September 1998, while several have been updated or added since 2006. 5

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2012

Good Clinical Practice: A Question & Answer Reference Guide - May 2012
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, Ukraine, 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 2012