Food and Drug Administration Guidance: Supervisory Responsibilities of Investigators

Abstract

Conducting clinical trials for diabetes can present researchers with a number of regulatory questions. The Food and Drug Administration (FDA) has increased regulatory enforcement at clinical sites, with an increased emphasis on oversight by principal investigators (PIs; referred to by the FDA as the clinical investigator). The FDA has issued a guidance document, “Guidance for Industry: Investigator Responsibilities— Protecting the Rights, Safety, and Welfare of Study Subjects” (2009), to assist investigators and sponsors. This guidance document breaks new ground regarding the FDA's expectations for investigator oversight of subinvestigators and study staff. The guidance document corresponds with a sharp increase in FDA warning letters to PIs for noncompliance with good clinical practice regulatory requirements. For the first time, an FDA guidance document discusses issues such as the delegation of authority, standard operating procedures, and training of study staff. The FDA provides specific examples with particular emphasis given to appropriate delegation of duties by the PI and ensuring that the clinical staff entrusted to carry out the trial has had adequate training and experience in order to allow them to perform the designated tasks.

Keywords

clinical trials devices Food and Drug Administration Food and Drug Administration guidance good clinical practice investigator responsibility training

References

U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for industry: Protecting the rights, safety, and welfare of study subjects—supervisory responsibilities of investigators. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127740.pdf. Accessed October 28, 2010.

Ball

, Food and Drug Administration. Harmonizing regulatory approaches to clinical trials to improve quality and compliance. http://carl1anderson.wordpress.com/h1n1-joint-fda-ftc-warning/ball-harmonizing-regulatory-approaches-to-clinical-trials-2/. Accessed December 30, 2010.

Food and Drug Administration, Office of the Commissioner, Office of Good Clinical Practice. GCP questions, slide attached to email response, February 24, 2010. http://carl1anderson.wordpress.com/h1n1-joint-fda-ftc-warning/fy09-bimo-data/. Accessed December 30, 2010.

Food and Drug Administration. Inspections, compliance, enforcement, and criminal investigations: Warning letters. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm. Accessed, May 14, 2010.

Anderson

. Protocol adherence and recordkeeping: The twin pillars of GCPs. http://carl1anderson.files.wordpress.com/2009/09/protocol-adherence-and-recordkeeping.pdf. Accessed December 30, 2010.

Department of Health and Human Services, Food and Drug Administration. Statement of investigator, Form FDA 1572. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf. Accessed October 28, 2010.

U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for industry: Investigator responsibilities—protecting the rights, safety, and welfare of study subjects. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf. Accessed October 28, 2010.

Food and Drug Administration. Code of Federal Regulations title 21, part 50.27(a). http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm. Accessed October 28, 2010.

U. S. Department of Health and Human Services, Food and Drug Administration, Office of Good Clinical Practice, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Information sheet guidance for sponsors, clinical investigators, and IRBs. Frequently asked questions—statement of the investigator (Form FDA 1572). http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf. Accessed October 28, 2010.

10.

U. S. Department of Health and Human Services, Food and Drug Administration. Inspections, compliance, enforcement, and criminal investigations. Warning letter to clinical investigator Richard Holub, MD, 01-Oct-08. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048111.htm. Accessed October 28, 2010.

11.

U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry. E6 good clinical practice: Consolidated guidance. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf. Accessed October 28, 2010.

12.

U. S. Department of Health and Human Services, Food and Drug Administration. Inspections, compliance, enforcement, and criminal investigations. Warning letter to clinical investigator, Thomas Gazda, M.D., 11/24/09. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm196080.htm. Accessed October 28, 2010.

13.

Food and Drug Administration. Code of Federal Regulations title 21, part 812.25(e). http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm. Accessed October 28, 2010.

14.

U. S. Department of Health and Human Services, Food and Drug Administration. Inspections, compliance, enforcement, and criminal investigations. Warning letter to clinical investigator Dov Linzer, M.D., 6/12/09. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm174744.htm. Accessed October 28, 2010.

15.

U. S. Department of Health and Human Services, Food and Drug Administration. Inspections, compliance, enforcement, and criminal investigations. Warning letter to clinical investigator Timothy Summers, MD, 2/24/10. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202614.htm. Accessed October 28, 2010.