Good Clinical Practice: A Question & Answer Reference Guide - May 2012 - (Page 689)

PART 312 — INVESTIGATIONAL NEW DRUG APPLICATION Subpart A — General Provisions Sec. 312.1 312.2 312.3 312.6 312.8 312.10 312.20 312.21 312.22 312.23 312.30 312.31 312.32 312.33 312.38 312.40 312.41 312.42 312.44 312.45 312.47 312.48 Scope. Applicability. Definitions and interpretations. Labeling of an investigational new drug. Charging for investigational drugs under an IND. Waivers. Subpart B — Investigational New Drug Application (IND) Requirement for an IND. Phases of an investigation. General principles of the IND submission. IND content and format. Protocol amendments. Information amendments. IND safety reports. Annual reports. Withdrawal of an IND. Subpart C — Administrative Actions General requirements for use of an investigational new drug in a clinical investigation. Comment and advice on an IND. Clinical holds and requests for modification. Termination. Inactive status. Meetings. Dispute resolution. Subpart D — Responsibilities of Sponsors and Investigators 312.50 312.52 312.53 312.54 312.55 312.56 312.57 312.58 312.59 312.60 312.61 312.62 312.64 312.66 312.68 312.69 312.70 General responsibilities of sponsors. Transfer of obligations to a contract research organization. Selecting investigators and monitors. Emergency research under § 50.24 of this chapter. Informing investigators. Review of ongoing investigations. Recordkeeping and record retention. Inspection of sponsor’s records and reports. Disposition of unused supply of investigational drug. General responsibilities of investigators. Control of the investigational drug. Investigator recordkeeping and record retention. Investigator reports. Assurance of IRB review. Inspection of investigator’s records and reports. Handling of controlled substances. Disqualification of a clinical investigator. 689

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