Liz Wool offered a webinar for Investigators, Sub-investigators, Study Coordinators, Research Nurses and Research Coordinators at Columbia's College of Physicians and Surgeons titled, "The Changing Landscape of FDA Expectations: Investigator Supervisory Responsibilities"

Learning Objectives

• Discuss current FDA inspection trends involving Investigators and sites.
• Explain FDAs definition for 'appropriate delegation' of Investigator responsibilities to study staff.
• Identify minimum site standards and procedures the FDA looks for during an Investigator – site inspection.
• Identify minimum site staff

Services offered reach academic centers need to develop infrastructure for clinical research for both industry s and investigator sponsored studies that are compliant with FDA and OHRP regulatory requirements. This includes business enterprise wide analysis, risk assessment, risk identification and risk priority, to strategize the individualized approach to clinical research quality systems development and deployment.

This includes standard operating procedures, work infrastructure and on the job training/ training environments for all staff to support those who execute clinical trials.

Liz wool's experience as both a research nurse at John Hopkins Hospital, in industry and as an educator provides added value to implementing target, specific solutions to both academic health centers and hospitals.