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T-23: Delegation of Responsibilities-Guidance in Response to FDA Audits

Poster Presenter

      Katelyn Patterson

      • Leidos Biomedical Research, Inc
        United States


This poster aims to represent a concise compilation of many of the issues identified by the FDA during inspections along with information identified by OCRPRO/ RCHSPP CTM team to provide practical experience-based suggestions for resolving these issues.


N/A. This was a guidance poster with information regarding FDA inspections, findings, and how sites can avoid the errors found in the findings. This included FDA and Regulatory Compliance and Human Subjects Protections Program (RCHSPP) findings


Quantitative data is noted regarding delegation findings from CDER Warning letters and RCHSPP deviations issued.


As identified in the Code of Federal Regulations, the ultimate responsibility of a Clinical Investigator or Principal Investigator is to oversee the protocol being conducted in a manner that protects the rights, safety, and wellbeing of subjects and provides accurate verifiable data. vi Based on recent FDA findings related to investigator oversight, there appears to be a lack of understanding of the significance of clinical investigator oversight industry-wide. Findings by RCHSPP have been significantly lower, we believe at least in part due to the tools and preventative measures provided. The aim of this poster is to offer recommendations for adequate oversight and how this can be effectively documented for investigators that have been implemented within OCRPRO/ RCHSPP CTM. Tools presented are not meant to absolve investigators of their responsibilities during a trial, but to help them show that they are meeting these requirements. As indicated in a recent FDA warning letter, “hiring qualified, and providing training may help with performance, but does not substitute for the responsibilities as the clinical investigator to supervise those aspects of the studies delegated to research staff.”vii The importance of documented investigator oversight cannot be stated enough. While some tools presented are not specifically required by regulations, several are highly recommended as described in the Guidance for Industry Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects October 2009.viii All of the tools presented are available from RCHSPP CTM for clinical investigators to assist in meeting their responsibilities.