Good Clinical Practice: A Question & Answer Reference Guide - May 2012 - (Page 355)

Section 10: FDA Inspections, Quality Assurance Activities, and Study Auditing 10.1 Q. During late 2010, Congress was said to have considered extending the FDA’s authority to give it the explicit power to inspect all the parties involved in the clinical research process. What are the goals here, and how could this change the FDA’s authorities to oversee and inspect the clinical trial process? A. Apparently, Congress was working with the FDA to “clarify” the agency’s authorities to inspect the parties involved in clinical trials. An untitled “discussion draft” bill posted on the website of the House Energy and Commerce Committee was designed, in part, to provide the agency with more explicit and direct authority to inspect clinical investigators, sponsors, contract research organizations, site management organizations, IRBs, and others participating in a clinical trial. Of course, the agency already inspects such entities, a right it possesses through its authority over clinical trial sponsors. FDA officials have noted, however, that the draft legislation, which ultimately was not introduced or passed, would have provided the agency with clearer authority over all key aspects of clinical trials, which continue to become more complex and involve more entities. Under a section entitled, “Clarification of Inspection Authority Related to BIMO and IRB Inspections,” the discussion draft stated that the FDA would be authorized “to enter, at reasonable times . . . any establishment associated with a clinical investigation . . . (including the premises of any clinical investigator, sponsor, monitor, contract research organization, site management organization, person that oversees or participates in data acquisition, data generation, data archiving, or data analysis, institutional review board, or any other person, other than a subject, that participates in the conduct of a clinical investigation of a drug) . . .” Some have wondered publicly if the FDA is taking steps to look more closely at the roles of entities that have become increasingly important players in clinical research. In a September 2010 note to investors, analysts at Wells Fargo Securities noted that “controversy surrounding data integrity and proper study management has shifted [FDA] focus to both preclinical and clinical practices. In our view, this shift opens the door for 1) greater scrutiny of clinical trials and, with the rising involvement of CROs, 2) more warning letters issued to CROs. While we do not view this emerging trend to be overly insidious for CROs, we do feel investors should brace for increasing headline risk from greater FDA scrutiny.” It should be noted that FDA already has an active program of inspections that already includes inspections of CROs and IRBs. 10.2 Q. Many were surprised when the U.S. Justice Department announced that it had charged a former GlaxoSmithKline vice president and attorney with making false statements and obstructing a federal investigation into marketing practices for the antidepressant drug Wellbutrin for unapproved uses. To what degree are government attorneys expected to focus on corporate executives for regulatory noncompliance and fraud outside of the drug marketing area, which had seemed to be the focus previously? A. The U.S. Justice Department’s November 2010 announcement of charges against Lauren Stevens, 60, and the possible jail time associated with a resultant conviction (the obstruction charge carries a maximum penalty of 20 years in prison, and each of four false-statement counts carries a maximum penalty of five years in prison), certainly caught the attention of many in the pharmaceutical industry. And this was despite the fact that the medical industry had long anticipated a federal government focus on top industry officials in its enforcement efforts. Today, that focus has extended to other areas of enforcement, including cases of serious clinical trial noncompliance (see following question below). In response to a March 2010 Government Accountability Office report entitled, “Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal Misconduct Investigations,” the FDA formed a senior-level committee “to enhance coordination and strategic alignment between the FDA’s Office of Criminal Investigations and other Agency components.” Among the committee’s recommendations was “to increase the appropriate use of misdemeanor prosecutions, a valuable enforcement tool, to hold responsible corporate officials accountable,” 355

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