Investigator-Initiated Research

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2023 Agenda

Friday, September 28, 2023 at 1:15 to 2:00                                                                                               Track: Investigator-Initiated Research

Setting Up Your IIS Program for Success – From Ideation to Dissemination

Investigator-initiated studies (IISes) are clinical investigations that are developed by physicians. A successful IIS program requires certain elements to ensure that studies are well-designed, scientifically sound, address an important knowledge gap, and provide reliable, high-quality data on which to draw conclusions and insight. The right team will work collaboratively with the physician investigator to take a concept from ideation to study startup and from data analysis to dissemination. 309
Presenter: Amy Starosciak, PhD, Director of Research Concept & Protocol Development, Miami Cancer Institute

Friday, September 28, 2023 at 2:05 to 2:50                                                                                      Track: Investigator-Initiated Research

Why does it have to be so complicated? How a cross-functional Feasibility Review carves a pathway to study success.

In a competitive research environment, it is critical to get a study through the startup process efficiently with a strong, feasible and well-written protocol. The University of Minnesota’s Clinical Research Support Center designed and implemented a structured Feasibility Review process that addresses startup challenges and efficiently helps investigators develop protocols ready for IRB submission and successful execution. The Feasibility Review is a valuable, cross-functional program providing timely expert guidance for study teams to efficiently and successfully launch and execute clinical research studies. Feasibility Review can be easily replicated, adapted, and implemented at other institutions to increase the quality and efficacy of academic research. 311
Presenter: Nicole Tosun, MS, CCRP, Senior Clinical Research Specialist, University of Minnesota

Saturday, September 30, 2023 at 3:25 to 4:10                                                                                        Track: Investigator-Initiated Research

Investigator-Initiated Research: From Start to Audit

Ms. Weidler will discuss the processes for investigator-initiated research protocol development and launch and discuss the perspective of a sponsor-investigator for an FDA audit. The experience of being a 100% electronic study for a 14-site NIH U-grant project will be presented. 313
Presenter: Erica Weidler, MEd, MA, CCRC, Research Associate/Assistant Professor, Phoenix Children's Hospital

Saturday, September 30, 2023 at 4:15 to 5:00                                                                                                 Track: Investigator-Initiated Research

Trials and Tribulations: Auditing and Monitoring Investigator Initiated Trials (IITs)

Investigator Initiated Trials (IITs) present unique regulatory and operational challenges and risks. Specialized skills and knowledge are required for implementing internal monitoring and auditing programs in order to achieve compliance leading to successful trial execution. This session will share monitoring and auditing programmatic plans and techniques to address the challenges of IITs as well as lessons learned and successes 315
Presenter: Wendy Portier, MSN, RN, CHRC, CHC, Consultant, Portier & Associates, LLC
Presenter: Cynthia Dunn, MSN, CCRP, RN, CCRA, Clinical Research Consultant, Crescent City Research Consulting LLC