Agenda

Clinical research billing is an increasingly complex and regulated process. In this session, representatives from UCLA and Yale will discuss how they use OnCore to support clinical research billing compliance from a multi-site perspective. They will discuss key considerations for implementing research billing policy and share their approaches to leveraging OnCore for an efficient and compliant billing process.

The regulatory landscape can be difficult to navigate with multiple IRBs (internal and external), updated human subjects regulations, HIPAA privacy and security, and Good Clinical Practice, among the other items to complete your clinical research study. This session, delivered from the perspective of the IRB office, will focus on the relationship between the IRB office and clinical trial units and include best practices for maximizing a relationship between the two units, utilizing your IRB as a partner in the research process, and minimizing issues when something goes awry.

The NCI has indicated that there are upcoming changes being made to the 2020 CCSG funding opportunity announcement (FOA) regarding protocol review monitoring systems (PRMS). These include codifying the role of disease-oriented groups in scientific review, eliminating rejection rate as a measure of rigor, clarifying the role of feasibility review and joint PRMS across centers for multi-site trials, among others. This presentation from April Firstencel, CRO Manager and OnCore Administrator at Case Comprehensive Cancer Center and Deb McCollister, Program Director, PRMS at the University of Colorado Cancer Center will discuss the upcoming changes as well as how OnCore can facilitate them.

While not currently mandated by any regulating body or funder, feasibility reviews are being implemented at many research organizations. With an estimated 20-50% of protocols closing without a single accrual at the site-level, organizations see the importance of determining where to invest resources prior to investing significantly in the entire activation process. To ensure fairness and success, these decisions should be evidence-based, not subjective. Forte has been utilizing machine learning to develop an accrual prediction algorithm. In this session, Wendy Tate, Director, Analytics at Forte will share Forte's progress, including initial collaborations and how this algorithm can fit into the feasibility review process.

Years have passed since you implemented OnCore. The goals you had during implementation are perhaps long in the past. How do you review and assess organizational goals to see if things are on track, or to make continuous improvements? And how do you revisit and realign your use of OnCore to support those goals? In this session, Natalie Hellmer, Senior Project Manager at Forte and Jill McKinley, Staff Augmentation at Forte will help you learn the key steps to driving a process improvement project to reality.

This panel discussion, including representatives from Yale, University of Alabama Birmingham, University of Florida and University of Arizona, will discuss a "top 10" list in four areas: top 10 issues that discourage clinical research, top 10 mistakes made when conducting clinical research, top 10 recent regulatory changes and top 10 impactful clinical research breakthroughs.

When Duke implemented OnCore, they wanted to create a standardized clinical research experience to manage research from protocol creation to project closeout, create data transparency and align metrics with institutional goals. Emphasizing the minimum footprint, reports were developed and distributed to all Clinical Research Units (CRUs) for monitoring system use and required data capture. In this session, Denise Snyder, Associate Dean for Clinical Research at Duke University will share how Duke reviewed data and distributed information to CRUs. The process made their research leadership and business management have a better understanding of their clinical research portfolio and demonstrated how standardized data capture drives improved research business decisions.

When managing a website for a cancer center or academic medical center, there are a variety of ways to design sites, technologies to use and best practices to consider. This panel discussion, featuring representatives from University of Nebraska Medical Center, Medical College of Wisconsin and Case Comprehensive Cancer Center, will share their experiences with creating websites, accounting for ease of use and accessibility, what information is kept public or private, and more.