Developing Monitoring Plans for Investigator-Initiated Clinical Trials

Tuesday, November 14, 2017 - 11:00am to 12:00pm

Albert Eye Research Institute Auditorium

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Sandra Sather, MS, BSN, CCRA, CCRC


One of the critical tools for supporting quality study outcomes for a clinical trial is a study monitoring plan. Sam Sather will discuss the importance of identifying who holds the role of the sponsor in investigator-initiated clinical trials and assuring clear expectations of the sponsor's role when monitoring a trial. She will also identify the various types of monitoring (with and without technology integration) in the post ICH GCP E6 (R2) world and describe how to recognize the essential monitoring plan components needed for your specific trial. This presentation will cover the requirements and best practices of establishing, maintaining, and complying with a study monitoring plan for investigator-initiated trials. Join us for this session and go through a real life case example of where adequate monitoring plans can support investigator-initiated trial success.


Nagorski, Susan