Good Clinical Practice: A Question & Answer Reference Guide - May 2012 - (Page 37)

Section 2: Investigators/Sites 2.1 Q. What do FDA standards indicate as the qualifications that a person must possess to be a clinical investigator? Put another way, when is an individual considered to be “qualified” to conduct a clinical trial? A. FDA GCP regulations at 21 CFR 312.53(a) require that investigators be “qualified by training and experience as appropriate experts to investigate the drug.” The ICH GCP guideline adds that an investigator “should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial and should meet all the qualifications specified by the applicable regulatory requirements.” The FDA acknowledges, however, that its regulations do not define minimum qualifications for clinical investigators, and points out that sponsors have considerable discretion in determining the training and experience necessary for a particular trial. “The regulations do not specify the minimum requirements nor do the regulations specify what qualifications an investigator must have in order to be considered qualified by training and experience to conduct a study,” the agency says in its May 2010 guidance/information sheet entitled, “Frequently Asked Questions-Statement of Investigator (Form FDA 1572).” “Sponsors have discretion in determining what qualifications, training, and experience will be needed, based on the general recognition that this would include familiarity with human subject protection (HSP) regulations (i.e., 21 CFR Parts 50 and 56) and practices as well as good clinical practice (GCP) regulations (see 21 CFR Part 312) and standards (e.g., ICH E6) for the conduct of clinical studies.” While selecting qualified investigators is clearly a sponsor responsibility under FDA regulations, the May 2010 agency guidance suggests that the investigator is expected to make a self-assessment of his/her qualifications as well after considering the study protocol and the demands of the study. “The investigator’s signature on [the Form FDA 1572-Statement of Investigator] constitutes the investigator’s affirmation that he or she is qualified to conduct the clinical investigation and constitutes the investigator’s commitment to abide by FDA regulations in the conduct of the clinical investigation.” In a January 2011 interview, an FDA field investigator noted that sponsors can do more, in some cases, to document their assessments of the qualifications of prospective investigators. “An area [in which we sometimes see issues] is the selection of clinical investigators—that is, ensuring that the sponsor has selected clinical investigators who are qualified and to have an assessment of those qualifications,” the field investigator noted. “So if the sponsor states in a protocol that it must be a physician, or that the individual must have certain expertise or board certification, the sponsor must ensure that each of these investigators selected for the protocol meets those requirements and that there is documentation to show that [assessment]. It’s very surprising given the research that is available in terms of all the queries you can do on investigators, and the idea therefore that sponsors would end up selecting even some investigators that don’t meet the criteria.” 2.2 Q. As the agency makes clear in its May 2010 guidance entitled, “Frequently Asked Questions-Statement of Investigator, Form FDA 1572,” sponsors “have discretion in determining what [investigator] qualifications, training, and experience will be needed . . .” for a clinical study. Obviously, however, the general process is more straightforward for studies based in the US, EU, or other more familiar territories in which there is an understanding of the education and training necessary to obtain a medical degree and related degrees. This is not as straightforward in some emerging locations, in which increasing numbers of FDA-regulated clinical trials are being conducted. In assessing the qualifications of possible clinical investigators and others involved in clinical trials to be initiated in these emerging locations, what are the FDA’s expectations of what sponsors must do in verifying and considering the qualifications of those individuals considered as potential clinical investigators/key staff in clinical trials—that is, in countries in which the meaning of certain degrees, and the qualifications/experience necessary to obtain those degrees, may not be as straightforward or as well understood as in more traditional or familiar markets? 37

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