Good Clinical Practice: A Question & Answer Reference Guide - May 2012 - (Page 677)

PART 56 — INSTITUTIONAL REVIEW BOARDS Subpart A — General Provisions Sec. 56.101 56.102 56.103 56.104 56.105 56.106 56.107 56.108 56.109 56.110 56.111 56.112 56.113 56.114 56.115 56.120 56.121 56.122 56.123 56.124 Scope. Definitions. Circumstances in which IRB review is required. Exemptions from IRB requirement. Waiver of IRB requirement. Registration. Subpart B — Organization and Personnel IRB membership. Subpart C — IRB Functions and Operations IRB functions and operations. IRB review of research. Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. Criteria for IRB approval of research. Review by institution. Suspension or termination of IRB approval of research. Cooperative research. Subpart D — Records and Reports IRB records. Subpart E — Administrative Actions for Noncompliance Lesser administrative actions. Disqualification of an IRB or an institution. Public disclosure of information regarding revocation. Reinstatement of an IRB or an institution. Actions alternative or additional to disqualification. AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n. SOURCE: 46 FR 8975, Jan. 27, 1981, unless otherwise noted. 677

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