Context
The ultimate measure of the quality of the conduct of a clinical trial is a site investigator being able to have a “clean” result from a sponsor or FDA Audit. In this exercise, you will gain insights about the FDA inspection process by exploring a FDA Audit 483 Letter issued to a clinical research investigator. It is important to understand how to analyze the issues cited by the FDA, how to reply to an FDA 482 Letter and the practice of establishing a CAPA for each cited issue to demonstrate a commitment to quality.
INSTRUCTION;
Review 2012, 2013 and 2014 FDA Warning letters from the FDA Website http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ (Links to an external site.)Links to an external site.
Choose one that is issued a clinical investigator and report on your findings
(DO NOT report on a FDA 483 issued to a sponsor, a manufacturer or a CRO, this should ONLY be an inspection report letter for a principal investigator at a research site).
Create a 4 paragraph report that includes the following elements:
Be sure to indicate the date of inspection.
Who the letter was addressed to.
The violations and associated regulations, and FDAs key instructions.
Include the URL for the warning letter.
In your final paragraph, apply what you have learned about risk based monitoring and quality assurance in this module, including information from the FDA webinar, and suggest ways for these entities to improve processes (e.g., a CAPA).
Grading Criteria; Criteria Points
Reporting on dates, locations, contents, violations, regulations and FDAs key instructions.
URL for warning letter.
Applying module content- discuss how the clinical investigator would apply risk mitigation and quality improvement to address these violations and avoid reoccurrence?
