Detecting and Addressing the Quality Pitfalls at Study Sites

About this session

How can sites decrease the most common non-compliance issues cited in regulatory inspections? The types and frequency of these findings have not changed significantly in the past decade. With increasing complexity in research protocols, quality remains a concern to regulatory authorities. While monitors play a significant role in ensuring site performance and compliance, U.S. Food and Drug Administration notices place the onus on site personnel. In this presentation, we will highlight areas of deficiencies seen over many years at investigator sites. We will also discuss common inspection findings and how to spot the pitfalls that sites need to address in order to ensure compliance in conduct, performance, and overall execution of clinical trials.
CEU: 1.00 ACRP

Speakers

• SA

  Suheila Abdul-Karrim

  MICR CSci, RQAP-GCP · Independent Clinical Research Consultant

  Speaker

• JS

  Jerry Stein

  President, Summer Creek Consulting, LLC, Independent Clinical Research Professional, Medical Writer · Consultant

  Speaker