Investigator-Initiated Research

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2024 Agenda

Sat., Sept 28 8:30 to 9:15                                     Track: Investigator Initiated Research
Close Out Phase of a Clinical Research Study

The close out stage is labor intensive and requires all functional areas to work collaboratively to ensure a timely and effective close out. Ms. Baker will describe the steps to close a study, what functional areas are involved and what actions are needed for the IRB as well as data review, regulatory review, safety review, and statistical review. 517

Presenter: Layla Baker, MBChB, MPH, CCRP, Senior Clinical Research Manager, Elevance Health/ Carelon Research

Sat., Sept 28 9:20 to 10:05                                   Track: Investigator Initiated Research
Investigator Initiated Trials in an Academic Setting

Ms. Rajakumaran will consider the process of how the Centre for Clinical Trial Support functions as a study coordinating centre in managing multi-centre Investigator Initiated trials. This includes, study intake, study start-up activities, getting sites activated, providing ongoing support to participating sites, data management, monitoring, regulatory submissions, and close-out. 519

Presenter: Subitha Rajakumaran, BSc, CCRP, Senior Project Manager, Trials Operations, Sunnybrook Research Institute

Sat., Sept 28 10:50 to 11:35                                 Track: Investigator Initiated Research
Challenges Implementing Centralized Monitoring for Multi-Center Investigator-Initiated Trials at an Academic Medical Center

Ms. Reid will delve into the intricate journey of implementing a centralized monitoring approach at a large oncology academic medical center and explore the multifaceted challenges faced during the development phase. This session aims to provide an overview of the hurdles, focusing on data integrity, communication, standardization, regulatory compliance, site coordination, training, and technology integration. 521

Presenter: Rebecca Reid, BS, CCRA, Senior Clinical Research Monitor, University of Miami

Sat., Sept 28 11:40 to 12:25                                 Track: Investigator Initiated Research
What’s Drugs Got to Do With It? Using Supplements and Vitamins as Drugs

What do we need to know about conducting Investigator Initiated Research with Supplements and Nutrients as pharmaceuticals? The prevalence and use of vitamins and supplements continues to rise. Ms. Wintering will discuss considerations when using supplements for self-care or as a test article in clinical research. Is Investigational New Drug application with FDA oversight required? Understanding the mechanism, clinical effect, optimal dosing, and side effects/drug interactions of all nutrients and supplements should be a primary goal of research. When participants use supplements regularly, what are the implications for safety in clinical research that uses other drugs? Ms. Wintering will discuss controversy and ethical considerations when using vitamins and supplements as pharmaceuticals. Case examples will be presented. 523

Presenter: Nancy Wintering, MSW, LCSW, CCRP, Assistant Director of Research, Thomas Jefferson University

Sat., Sept 28 1:40 to 2:25                                     Track: Investigator Initiated Research
How to Conduct IND and IDE Studies - From a Sponsor Perspective

Investigators with a novel study idea may require an Investigational New Drug Application or Investigational Device Exemption application.  A sponsor’s responsibility is to assist investigators and study teams with every step of this process. 525

Presenter: Laura Adkins, MAP, BA, CCRP, CCRA, CRS, AdvCRS, Director, Office of Research Regulatory Affairs, University of Arkansas for Medical Sciences

Sat., Sept 28 2:30 to 3:15                                     Track: Investigator Initiated Research
How to Effectively Train a Sponsor-Investigator

Sponsor-Investigators are often unaware of the complete set of responsibilities they assume when taking on this dual role. Dr. Statler will provide training strategies and curriculum content intended to support the development of such education. 527

Presenter: Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality and Safety, Dartmouth-Hitchcock Medical Center