Agenda

The Onsemble Conference is the premier conference for the research community. The 2019 Fall Onsemble conference will feature sessions in the following areas:

  • Data-Driven Best Practices
  • Recruitment and Accrual
  • Financial Management
  • Regulatory Management
  • Adoption and Training
  • Technical and Informatics
  • Center Leadership

Monday, September 16, 2019

9:00 am

Speaker:

  • Doug Vosters
    Training Specialist, Forte

Workshop: OnCore Financials Certification

Monday 9:00 am - 5:00 pm

OnCore Certification provides training and best practices for configuring and supporting OnCore, including discussions of advanced workflows and lesser-known features.  It is a combination of instructor-led training, plus an exam and a hands-on build project to be completed by each attendee within 1 month of attending the course. OnCore Certification is for users who already have a basic knowledge and familiarity with the application; candidates must know how to create and manage protocols and subjects in OnCore and have at least six (6) months of experience working in their organization’s OnCore environment before attending.

Speaker:

  • Bishoy Anastasi
    Subject Matter Expert & Course Trainer,

Workshop: Coverage Analysis Certification™

Monday 9:00 am - 5:00 pm

This 2-day, interactive workshop offers up to 16 hours of continuing education credit through SOCRA & ACRP, and covers OnCore financials implementation through the clinical research budgeting and billing compliance continuum.

The training includes practical, step-by-step tutorials that address:
-Clinical research billing regulations
-
Coverage analysis best practices
-Workflow engineering considerations related to budgeting and      billing compliance
-Research charge master considerations and functionality
-Strategies to maximize the utility of OnCore billing grids for EHR interfaced and non-interfaced sites

This session is designed and best suited for coverage analysis, budget development, and/or clinical research billing compliance stakeholders. Attendees will receive tools and checklists adopted by leading medical centers, as well as a comprehensive participant guide that provides best practice instructions to create comprehensive billing grids and perform coverage analysis in OnCore. Attendees will also have the opportunity to become Certified Coverage Analysts™ by successfully demonstrating subject matter proficiency through a post-training assessment and practicum.

The training is led by Bishoy Anastasi, a national clinical research subject matter expert, particularly in coverage analysis, clinical research billing compliance and research pricing. In addition to his 20 years of clinical research management experience, Bishoy co-authored and oversees coverage analysis and research pricing policies and processes for a leading academic medical center. All previous attendees who have been surveyed would recommend this training to others. This two day workshop has a separate fee of $1,495, which includes the 2 day training, training materials, catered meals, and the post training assessment and practicum. A group discount of 10% off is offered to organizations that register a group of three or more for this workshop. Breakfast and lunch will be provided on both days of training as well as a hosted group social with refreshments and hors d’oeuvres on Monday evening.

Tuesday, September 17, 2019

9:00 am

Speaker:

  • Stephen Shapiro
    Training Specialist, Forte

Workshop: OnCore 101

Tuesday 9:00 am - 5:00 pm

This session is designed for those who are new to OnCore (less than six months experience). If you are interested in seeing the great things that can be accomplished using OnCore, this hands-on workshop is for you! Training Specialist Stephen Shapiro will walk trainees through the quick wins and interesting features of OnCore including task lists, protocol search, Forte Insights dashboards, subject visit management and sponsor invoicing. This session is a great opportunity to get answers to all of your OnCore questions!

ACRP CEUs

Speaker:

  • Doug Vosters
    Training Specialist, Forte

Workshop: OnCore Financials Certification

Tuesday 9:00 am - 5:00 pm

OnCore Certification provides training and best practices for configuring and supporting OnCore, including discussions of advanced workflows and lesser-known features. It is a combination of instructor-led training, plus an exam and a hands-on build project to be completed by each attendee within 1 month of attending the course. OnCore Certification is for users who already have a basic knowledge and familiarity with the application; candidates must know how to create and manage protocols and subjects in OnCore and have at least six (6) months of experience working in their organization’s OnCore environment before attending.

Speaker:

  • Bishoy Anastasi
    Subject Matter Expert & Course Trainer,

Workshop: Coverage Analysis Certification™

Tuesday 9:00 am - 5:00 pm

Coverage Analysis Certification Training continued.

11:30 am

Lunch

Tuesday 11:30 am - 1:00 pm

All Attendees

1:00 pm

Speakers:

  • Shannon Roznoski
    Director, Product Management, Forte
  • MaryAnn Kempker
    Computer Software Validation Project Manager, Forte

Workshop: Change Control in Validated and Non-Validated Products

Tuesday 1:00 pm - 5:00 pm

How can organizations manage upgrades while making most efficient use of my time? What considerations should they be aware of if upgrading a validated system? Join Forte's MaryAnn Kempker, Computer Software Validation Project Manager and Shannon Roznoski Director, Product Management for an exploration of change control. Learn how a risk based approach can enable your organization to evaluate change and take steps to mitigate risk. Learn about considerations for validated products, including an overview of the regulations in 21 CFR Part 11, requirements for system validation, and maintaining validation through controlled use and change control. Participate in group activities using real-world examples to assess risk and plan change control.

ACRP & CBRN CEUs

3:00 pm

Speakers:

  • Makenzie Pick
    Solutions Consultant, Forte
  • Stephanie Lee
    Solutions Consultant, Forte

Workshop: Forte Solutions Overview: Getting the Most out of Onsemble

Tuesday 3:00 pm - 5:00 pm

Brush up on your knowledge of Forte products or get a refresher before attending Onsemble sessions. This workshop provides a foundation in Forte product workflows to equip you with the background you need to get the most from out of Onsemble. This session will give you a basic overview of solutions in a number of areas, including financial management, analytics and reporting, data management and study management.

ACRP CEUs

6:00 pm

Welcome Dinner

Tuesday 6:00 pm - 8:00 pm

Join us as we kick off the conference with a rooftop dinner at the Monona Terrace Convention Center! Enjoy networking with your peers while taking in the stunning views of Lake Monona.

All Attendees

Wednesday, September 18, 2019

6:45 am

Run/Walk around Madison

Wednesday 6:45 am - 7:30 am

Lace up your running shoes! New to the Onsemble conference this year, start your day with a group run or walk around scenic downtown Madison. Forte Run Club ambassadors will take you on a tour of some of Madison’s most iconic sights. Choose from a walk or two run pace groups for a fun 3-mile loop.

All Attendees

Yoga

Wednesday 6:45 am - 7:30 am

Start your day off with yoga led by local instructors! Yoga mats, towels, and water will be provided. Please arrive 5-10 minutes prior to the start of the session.

All Attendees

7:30 am

Breakfast

Wednesday 7:30 am - 8:30 am

All Attendees

8:30 am

Keynote

Wednesday 8:30 am - 9:45 am

All Attendees

10:00 am

Morning General Session

Wednesday 10:00 am - 10:45 am

All Attendees

11:00 am

Speaker:

  • Mariette Marsh
    Director, Human Subjects Protection & Privacy Program, University Of Arizona

Ask the IRB Director

Wednesday 11:00 am - 11:50 am

This session will offer an open Q&A with Mariette Marsh, the Director of the Human Subjects Protection Program and Privacy Office for the University of Arizona. She will address audience questions regarding regulations, workflows, how to work with your compliance units, and more. The session will provide an understanding of the compliance side of clinical research, with insight on how the compliance units can assist researchers with achieving study goals efficiently.

Regulatory ACRP & CBRN CEUs

Speakers:

  • Wendy Tate
    Director, Analytics, Forte
  • Sarah Stewart
    Assistant Director of Clinical Research, University of Wisconsin Carbone Cancer Center

Perspectives on Cancer Community Activation Timelines

Wednesday 11:00 am - 11:50 am

Cancer centers have competing deadlines from their institutions and clinical trial sponsors, including pressure to decrease study activation timelines. In this session, Sarah Stewart, Assistant Director of Clinical Research at the University of Wisconsin Carbone Cancer Center and Wendy Tate, Director, Analytics at Forte will explore study activation timelines as reported within Forte Benchmarks and comment on current trends and timing of study activation processes within the cancer center community, including whether shortening study activation timelines to a goal set by sponsors (industry or NCI) are achievable.

Data-Driven Best Practices ACRP & CBRN CEUs

Speaker:

  • Robert Haskins
    Systems Coordinator, Fox Chase Cancer Center

Filling the Gaps: Developing Role-Based OnCore Training

Wednesday 11:00 am - 11:50 am

In this session, Robert Haskins, Systems Coordinator at Fox Chase Cancer Center shares the lessons learned from developing and implementing a comprehensive, role-based OnCore training program. Starting from a basic, “one-size-fits-all” curriculum, discover how a combination of skills assessment, process mapping and focus on job responsibilities have made a difference at Fox Chase Cancer Center.

Adoption & Training ACRP & CBRN CEUs

Speaker:

  • Courtney Kennedy
    Manager, Clinical Trial Applications, UNMC/Nebraska Medicine

Optimizing Recruitment and Best Practices

Wednesday 11:00 am - 11:50 am

In this session, Courtney Kennedy, Manager, Clinical Trial Applications at UNMC/Nebraska Medicine discusses steps to take when refining and improving best practices for transformation. Kennedy will discuss realignment of resources and organizational structure, visibility to recruitment, transparent metrics and disease-focused teams.

Recruitment & Accrual ACRP & CBRN CEUs

12:00 pm

Lunch

Wednesday 12:00 pm - 1:00 pm

All Attendees

1:00 pm

Benchmarks "Top Performer"

Wednesday 1:00 pm - 1:50 pm

Join us as the winner of this Onsemble’s “Top Performer” Benchmarks award discusses processes and workflows that have made them successful. Presenting organization to be announced at the conference during the keynote.

Financials

Speakers:

  • John Eckmann
    CTMS Administrator, East Carolina University
  • Edye Edens
    Senior Research Compliance Consultant, First Class Solutions, Inc.
  • Ashley Anderson, MBA, ACRP-CP
    Assistant Director Clinical Research Administration and Compliance, University of Florida Health Cancer Center
  • Brian Sevier
    Director, Office of Clinical Research, University of Florida

Data Safety and Monitoring Committees: A Best Practices Discussion

Wednesday 1:00 pm - 1:50 pm

Significant time and effort are devoted to recording critical data on behalf of our Data Safety and Monitoring Committees within OnCore, and for recognizing the multiple institutional and regulatory needs this data serves. This leadership-level roundtable discussion facilitated by representatives from the University of Florida and Indiana University will explore the topic and articulate the institutional need or motivation for recording DSMC matters, as well as explore how organizations are doing so efficiently.

Data-Driven Best Practices ACRP & CBRN CEUs

Speakers:

  • Bishoy Anastasi
    Director - Clinical Research Finance, UCLA Dean’s Office
  • Kelly Anastasio, COC, CPC, CPCO, CPC-I, CLSSGB
    Associate Director of Clinical Trial Resources, Yale School of Medicine, Yale Center for Clinical Investigation

Leveraging OnCore for Clinical Research Billing Compliance

Wednesday 1:00 pm - 1:50 pm

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.

Leadership ACRP & CBRN CEUs

2:00 pm

Speakers:

  • Jason Cline
    Contracting Officer III, University of Florida, Office of Clinical Research
  • Brian Sevier
    Director, Office of Clinical Research, University of Florida

Leveraging OnCore in Contracting at an Academic Medical Center

Wednesday 2:00 pm - 2:50 pm

Clinical research contracting has historically been managed by staff with high legal acumen, but limited understanding of the approved billing plan, coverage analysis determinations and levels of risk associated with the contracted scope of work. Lack of familiarity with the subject matter and relying on scripted playbook positions is problematic and can lead to unnecessary risk exposure. In this presentation, Brian Sevier, Director, Office of Clinical Research and Jason Cline, Contracting Officer III of the University of Florida will document their experience with the implementation of OnCore and how UF’s clinical research contracting unit leverages all information available to deliver accurate and timely redline reviews of contracts.

Data-Driven Best Practices ACRP & CBRN CEUs

Speakers:

  • Kevin Dudley
    Programmer/Analyst IV, UCLA
  • Yvette Moreira
    UCLA

Developing Custom Notifications: Bridging the Gap

Wednesday 2:00 pm - 2:50 pm

Large organizations, multiple teams, custom workflows and endless handoffs - developing custom notifications can help keep workflows moving with minimal friction. In this session, Yvette Moreira, Implementation Specialist and Kevin Dudley, Programmer/Analyst IV will discuss how the University of California Los Angeles has developed a custom notification engine that keeps everything moving. They will explain how UCLA develops, tests and manages notifications, as well as user reactions to them.

Regulatory ACRP & CBRN CEUs

Benchmarks "Most Improved"

Wednesday 2:00 pm - 2:50 pm

Join us as the winner of this Onsemble’s “Most Improved” Benchmarks award discusses processes and workflows that have allowed them to improve their processes over the last year. Presenting organization to be announced at the conference during the keynote.

Technical & Informatics

Speaker:

  • Mariette Marsh
    Director, Human Subjects Protection & Privacy Program, University Of Arizona

Maximizing Your Relationship with Your IRB(s)

Wednesday 2:00 pm - 2:50 pm

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.

Leadership ACRP & CBRN CEUs

3:00 pm

Product & Plans Keynote

Wednesday 3:00 pm - 4:00 pm

All Attendees

4:00 pm

Product & Services Happy Hour

Wednesday 4:00 pm - 5:30 pm

Have a question you didn't get to ask at the end of your session, or interested in learning more about Forte solutions? We invite you to stop by to socialize during this happy hour to engage with the experts!

All Attendees

Thursday, September 19, 2019

6:45 am

Run/Walk around Madison

Thursday 6:45 am - 7:30 am

Lace up your running shoes! New to the Onsemble conference this year, start your day with a group run or walk around scenic downtown Madison. Forte Run Club ambassadors will take you on a tour of some of Madison’s most iconic sights. Choose from a walk or two run pace groups for a fun 3-mile loop.

All Attendees

Yoga

Thursday 6:45 am - 7:30 am

Start your day off with yoga led by local instructors! Yoga mats, towels, and water will be provided. Please arrive 5-10 minutes prior to the start of the session.

All Attendees

7:30 am

Breakfast

Thursday 7:30 am - 8:30 am

All Attendees

8:30 am

Speakers:

  • Lonnie Sorrells
    CSRC Informatics Systems Analyst, Waynes State University
  • Dan Paduchowski
    Business Analyst and Developer, Wayne State University

EDC Implementation and Validation: The B side

Thursday 8:30 am - 9:20 am

In this session, the Wayne State team will share their experiences implementing Forte EDC, including working with Forte to achieve 21 CFR part 11 compliance. They will provide an overview of the implementation and validation processes, including resources required, timelines and documentation. The team will also share how Forte’s assistance in creating workflows models, SOPs and functional system testing increased efficiency in validation. Finally, the will provide insights into lessons learned, operational practices and case studies following their EDC rollout.

Regulatory ACRP & CBRN CEUs

Speakers:

  • Deb McCollister
    Research Manager, University of Colorado Cancer Center
  • April Firstencel
    Protocol Review and Monitoring Committee (PRMC) Manager, OnCore Administrator, Case Comprehensive Cancer Center
  • Alyssa Gateman, MPH, CCRP
    Associate Director of Quality Assurance, Yale Center for Clinical Investigation

How Can OnCore Facilitate the Upcoming PRMS Changes?

Thursday 8:30 am - 9:20 am

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.

Leadership ACRP & CBRN CEUs

Speaker:

  • Katherine Eddleton
    Associate Director, University of Florida

Strategic Approaches to Identify Recruitment Issues and Interventions

Thursday 8:30 am - 9:20 am

In this session, Katherine Eddleton, Associate Director at the University of Florida (UF), shares UF's experience tracking projected vs actual enrollment for clinical studies and identifying studies at risk of not meeting minimum enrollment targets. Eddleton will focus on collecting and analyzing data and strategic approaches to effective intervention.

Recruitment & Accrual ACRP & CBRN CEUs

9:30 am

Speakers:

  • Mariette Marsh
    Director, Human Subjects Protection & Privacy Program, University Of Arizona
  • Cheryl Byers
    Director, Protocol Review & Monitoring Systems and Regulatory Affairs, Moffitt Cancer Center

Leveraging Commercial IRB and IBCs for Study Activation: A Case Study

Thursday 9:30 am - 10:20 am

In this session, Cheryl Byers of Moffitt Cancer Center and Mariette Marsh from the University of Arizona will discuss their centers' reliance on commercial IRBs and IBCs to provide regulatory oversight of their research portfolio. They will discuss how they have established excellent relationships and open communication with IRBs. They'll also share how consistent education of regulatory staff and repetition of the submission processes has led to improved turnaround times and facilitates study activation. Finally, they will share their experience contracting with a commercial IRB and IBC to assist sites in obtaining the necessary buy-in at the institutional level to facilitate the study start up process.

Regulatory ACRP & CBRN CEUs

Speakers:

  • Jill McKinley
    Staff Augmentation, Forte
  • Ann Kreeger
    Program Manager, Forte
  • Stephen Shapiro
    Training Specialist, Forte

Marketing 101: Driving Adoption of New Systems

Thursday 9:30 am - 10:20 am

Now that you've implemented important systems to help your institution, how do you continue to keep people excited and engaged to drive the adoption so that you see the value? In this session, Forte representatives will cover some Marketing 101 strategies and specific tactics, helping to shape perceptions, influence staff and increase adoption of systems.

Adoption & Training ACRP CEUs

Speakers:

  • Joe Stokes
    Associate Director, Office of Clinical Research, University of Florida
  • Kirsten Linsenmeyer
    OnCore Administrator and Team Lead, The Ohio State University James Comprehensive Cancer Center

OnCore and Vestigo Integration – Improving Investigational Pharmacy Operations

Thursday 9:30 am - 10:20 am

As organizations rely more and more on data systems to manage their clinical research operations, it is imperative to find ways to integrate these systems to minimize redundancies in staff effort and create sources of truth for information. In this presentation, Joe Stokes, Associate Director, Office of Clinical Research from the University of Florida and Kirsten Linsenmeyer, OnCore Administrator from The Ohio State University discuss their approaches to integrate the OnCore CTMS with the Vestigo investigational drug management system.

Technical & Informatics ACRP & CBRN CEUs

10:30 am

Speakers:

  • Natalie Hellmer
    Senior Project Manager, Forte
  • Doug Vosters
    Training Specialist, Forte

OnCore Charge Master Implementation Guidance

Thursday 10:30 am - 11:20 am

Creating charge master events in OnCore is simple. Determining the ‘best’ way to set up an event to support your goals and needs is challenging and complex. This session will explore the implications of charge master events set up through common implementation scenarios. Representatives from Forte's project management and training teams will be on hand to share their experiences and expertise.

Financials ACRP & CBRN CEUs

Speaker:

  • Stuart Cotter
    Director, Product Success, Forte

Implementation, Validation and Best Practices Using Forte eReg

Thursday 10:30 am - 11:20 am

In this session, Forte eReg customers will share their experiences with implementation and 21 CFR Part 11 validation of their system. They will share their timelines, roles involved in the project and more, as well as best practices and lessons learned from their experiences with the Forte eReg system.

Regulatory ACRP & CBRN CEUs

Speaker:

  • Wendy Tate
    Director, Analytics, Forte

Accrual Prediction Through Machine Learning in Reviewing Protocol Feasibility

Thursday 10:30 am - 11:20 am

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.

Leadership ACRP & CBRN CEUs

Speaker:

  • Jeff Parks
    Product Manager, Forte

What Does Forte's Agile Transformation Mean for You?

Thursday 10:30 am - 11:20 am

Forte is in the midst of adopting Agile development methodology across all of our products. In this session, OnCore Product Manager Jeff Parks will explain what that means for OnCore. We'll describe how your feature requests are prioritized, developed, and released today, and how those processes are evolving.

Technical & Informatics ACRP CEUs

11:30 am

Lunch

Thursday 11:30 am - 1:00 pm

All Attendees

1:00 pm

Speaker:

  • Catee Mullen
    Director, Clinical Research Operations, Duke School of Medicine

The Road to a Successful OnCore Financials Interface and the Aftermath

Thursday 1:00 pm - 1:50 pm

Duke University, in partnership with Forte, developed a real-time interface between their general ledger system, SAP, and OnCore Financials. This interface was successfully launched in November 2018. In this session, Catee Mullen, Director Research Operations at Duke, will describe Duke's experience prior to OnCore Financials and the SAP-OnCore interface, the path they took to a successful implementation and their plans for the future.

Data-Driven Best Practices ACRP & CBRN CEUs

Speakers:

  • Chanel Mansfield, MPH, CCRP
    Special Projects Manager, Office of Regulatory Compliance, University of Colorado Denver | Anschutz Medical Campus
  • Neva Garner
    Research Facilitator/Trainer, University of Colorado Anschutz Medical Campus

Recruitment Support Strategies from an Institutional Perspective

Thursday 1:00 pm - 1:50 pm

In this session, Neva Garner and Chanel Mansfield from the University of Colorado-Denver showcase how the institution is planning to leverage OnCore and Insights to support recruitment boosting. Enrollment metrics will be viewable in Insights by study teams and institutional officials to motivate and support efforts on the back-end. Garner and Mansfield will also outline plans to evaluate and identify effective recruitment practices at the institutional and study team levels.

Adoption & Training ACRP & CBRN CEUs

Practices Behind Being A Forte Benchmarks Process Leader

Thursday 1:00 pm - 1:50 pm

Join us for this late-breaking session. Driven by Forte Benchmarks, this presentation by a top-performing organization will focus on an accrual/activation benchmark in which they excel. Organization, presenter, and metric to be presented soon.

Recruitment & Accrual

Speakers:

  • Amy Drake
    Senior Business Systems Analyst, The Ohio State University
  • Kirsten Linsenmeyer
    OnCore Administrator and Team Lead, The Ohio State University James Comprehensive Cancer Center

eReg Implementation and Considerations for Going Enterprise-wide

Thursday 1:00 pm - 1:50 pm

Implementing a new system is a large undertaking; especially a 21 CFR part 11 validated one. In this session, Kirsten Linsenmeyer, OnCore Administrator and Team Lead at The Ohio State University, will detail OSU's eReg implementation experience, including validation of the system, necessary OnCore changes and lessons learned in the process. Linsenmeyer will also discuss OSU's plans for the future including potential plans to go enterprise-wide.

Financials ACRP & CBRN CEUs

2:00 pm

Practices Behind Being A Forte Benchmarks Process Leader

Thursday 2:00 pm - 2:50 pm

Join us for this late-breaking session. Driven by Forte Benchmarks, this presentation by a top-performing organization will focus on an accrual/activation benchmark in which they excel. Organization, presenter, and metric to be presented soon.

Technical & Informatics

Speaker:

  • Stuart Cotter
    Director, Product Success, Forte

Regulatory Personnel and Organizational Document Management

Thursday 2:00 pm - 2:50 pm

Management of staff credentials can be an extremely cumbersome process for large clinical research organizations. Your regulatory team needs to have immediate access to staff credentials to avoid study start up delays and ensure continual maintenance of the regulatory documents. Additionally, keeping track of the IRB roster, Lab certificates and other organizational standards of practice need to be kept current. In this session, Stuart Cotter, Director of Product Success at Forte, will discuss how you can use an eRegulatory system to manage these tasks, boosting efficiency and compliance throughout this process.

Regulatory ACRP CEUs

Speaker:

  • Amy Drake
    Senior Business Systems Analyst, The Ohio State University

Project Management, Ticketing System, and Upgrade Tracking

Thursday 2:00 pm - 2:50 pm

How do you manage and keep track of all the OnCore administrative functions required to keep research operations operating efficiently? Organization is key in managing these tasks! In this talk, Amy Drake, Senior Business System Analyst at The Ohio State University will discuss different tools and techniques to manage administrative projects, help desk requests, administrative requests and even coordinating an OnCore upgrade.

Data-Driven Best Practices ACRP & CBRN CEUs

3:00 pm

Speaker:

  • Beth Kettenring
    Director, Office of Sponsored Programs, Ochsner Health System

Financial Impact of Non-Enrolling Industry-Sponsored Clinical Trials

Thursday 3:00 pm - 3:50 pm

In this session, Beth Kettenring from Ochsner Health System will share the results of a research project analyzing the study start-up timelines and data for 419 newly activated trials over a 4-year period. She'll share details of the comprehensive analysis, which aimed to identify trends and potential correlations between the various data elements, e.g. CRC time, contract turnaround, time to first consented.

Financials ACRP & CBRN CEUs

Speaker:

  • Jason Jaszewski
    Principal Administrator, Managed Infrastructure, Forte

Transitioning to Forte Managed Infrastructure

Thursday 3:00 pm - 3:50 pm

In this session, Jason Jaszewski, IT Director and Principal Administrator, Managed Infrastructure at Forte will be joined by an OnCore customer who moved from on-premises to Forte Managed Infrastructure. They will discuss their approach to preparing for the move, the lessons learned throughout the project and the benefits they have seen with Forte Managed Infrastructure.

Technical & Informatics ACRP CEUs

Speakers:

  • Nirav Shah, MD, MSHP
    Assistant Professor of Medicine, Medical College of Wisconsin
  • AnnMarie Eve
    IRB Operations Manager, Medical College of Wisconsin
  • Ryan Spellecy, PhD
    Ursula von der Ruhr Professor of Bioethics, Medical College of Wisconsin

Real-time IRB review process: A Smoother Pathway Toward Initial Approval

Thursday 3:00 pm - 3:50 pm

Lengthy review times for IRBs are a well-known barrier to research. Even when extensive pre-review is conducted post-meeting communications between the IRB and research team still result in delays. In response to this challenge, the Medical College of Wisconsin devised “Real-Time IRB,” a process that drastically reduces IRB review time. representatives of MCW will share the details of their process and the improved timelines they have seen as a result.

Regulatory ACRP & CBRN CEUs

Speakers:

  • Natalie Hellmer
    Senior Project Manager, Forte
  • Jill McKinley
    Staff Augmentation, Forte

Executing Process Improvements

Thursday 3:00 pm - 3:50 pm

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.

Leadership ACRP & CBRN CEUs

4:00 pm

Speakers:

  • Rhoda Arzoomanian
    Yale
  • Mark Marchant
    Director-Clinical Trials Administrative Office, University of Alabama at Birmingham
  • Chad Adams
    UACC Associate Director, Cancer Clinical Research, University Of Arizona
  • Brian Sevier
    Director, Office of Clinical Research, University of Florida

Top 10 Review in Clinical Research

Thursday 4:00 pm - 4:50 pm

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.

Leadership ACRP & CBRN CEUs

Speakers:

  • Denise Snyder, MS, RD, LDN
    Associate Dean for Clinical Research, Duke University School of Medicine
  • Catee Mullen
    Director, Clinical Research Operations, Duke School of Medicine

Begin with the End in Mind: Putting Data Planning into Practice

Thursday 4:00 pm - 4:50 pm

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.

Leadership ACRP & CBRN CEUs

Speaker:

  • Tim Spinler
    eLearning Developer, Forte

Improve Your Classroom Training with eLearning

Thursday 4:00 pm - 4:50 pm

Finding time to cover everything needed in a classroom session is challenging. In this session, Tim Spinler, eLearning Developer from Forte, discusses how to use eLearning before, during and after class, giving learners what they need, when they need it.

Adoption & Training ACRP & CBRN CEUs

6:30 pm

Final Night Dinner

Thursday 6:30 pm - 9:30 pm

Join us at the Edgewater located on beautiful Lake Mendota for drinks, dinner and entertainment.

All Attendees

Friday, September 20, 2019

7:30 am

Breakfast

Friday 7:30 am - 8:30 am

All Attendees

8:30 am

Speakers:

  • Natalie Hellmer
    Senior Project Manager, Forte
  • Becca Ennis
    Senior Support Engineer, Forte
  • Jeff Parks
    Product Manager, Forte

Financials Reporting - OnCore Reports and Insights

Friday 8:30 am - 9:20 am

How can you make the most of the financial reporting capabilities in your Forte solutions? In this session, Forte's Natalie Hellmer, Senior Project Manager, Jeff Parks, OnCore Product Manager and Becca Ennis, Senior Support Engineer will examine key standard OnCore reports, financial dashboards within Forte Insights and custom reports on the Exchange on Onsemble.net, with the goal of providing protocol- and portfolio-specific visibility into the financial lifecycle.

Financials ACRP CEUs

Speakers:

  • Anna Grant
    Manager of the PRMS office and OnCore Oncology, University of Nebraska Medical Center
  • April Firstencel
    Protocol Review and Monitoring Committee (PRMC) Manager, OnCore Administrator, Case Comprehensive Cancer Center
  • Becky Sharp
    Training and Applications Senior Analyst, Nebraska Medicine/UNMC
  • Courtney Kennedy
    Manager, Clinical Trial Applications, UNMC/Nebraska Medicine
  • Sandi Johnson
    Enterprise Research System Administrator, Medical College of Wisconsin

What's on Your Website?

Friday 8:30 am - 9:20 am

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.

Leadership ACRP & CBRN CEUs

Speakers:

  • Katie Fick
    Supervisor, Clinical Trials Business Office, H. Lee Moffitt Cancer Center
  • Matt Davis
    CTMS Protocol Analyst, Moffitt Cancer Center
  • Tara Ackerman
    Study Activation Coordinator II, H Lee Moffitt Cancer Center

Then and Now: How Small Changes Streamline Activation

Friday 8:30 am - 9:20 am

Clinical trial activation processes have been widely studied in the past, with many top research institutions seeking to improve activation timelines. In this presentation, the team at Moffitt Cancer Center will focus on several challenges of prior state activation processes and various steps the center underwent to overcome those challenges. By utilizing informatics, department restructuring and project management, Moffitt was able to streamline activation and improve communication across teams. These seemingly simple ideas can be replicated at other research organizations and used as a basis for improving site activation timelines.

Technical & Informatics ACRP & CBRN CEUs

9:30 am

How to Make Sure Your Site is Prepared for an FDA Inspection

Friday 9:30 am - 10:20 am

In this session, members of the Forte product management and validations teams will provide answers to your questions regarding audit readiness. We will cover questions related to Forte products as well as administrative planning and preparation. Attendees will have the opportunity to send in questions upon registration for the session.

Regulatory ACRP CEUs

Speaker:

  • Jill McKinley
    Staff Augmentation, Forte

Lessons Learned Roundtable (Double Session)

Friday 9:30 am - 11:20 am

In this session, Jill McKinley, Staff Augmentation at Forte, leads the roundtable session asking customers their best-learned lessons, advice they have and things they wished they knew.

Recruitment & Accrual ACRP CEUs

Speakers:

  • Mike Neuenfeldt
    Services Manager, Forte
  • Ajay Indrajit
    Senior Manager, Forte

How Forte Creates Customer Calendar Build Standards

Friday 9:30 am - 10:20 am

The Forte Business Operations Services (BOS) team builds a large volume of calendars—over 15,000 and counting! In this session, Forte representatives will share their standard practices for interpreting calendars and helping develop Institution Specific Guidelines (ISGs) for OnCore customers. This session will provide you with guidance on practices you may want to adopt when considering utilizing Forte Calendars.

Adoption & Training ACRP CEUs

10:30 am

Speakers:

  • Beau Grignon
    Senior Vice President, Engineering & Infrastructure, Forte
  • Michael Rauwerdink
    Director, Software Engineering, Forte

Discussion Groups: Epic and Cerner Users

Friday 10:30 am - 11:20 am

In this session, attendees will participate in discussion groups related to best practices, addressing common challenges and getting the most from your OnCore/EMR integrations. The session will be moderated by Beau Grignon, Forte's SVP of Engineering & Infrastructure, and Mike Rauwerdink, Director of Software Engineering. Beau and Mike will facilitate discussion related to OnCore/EMR integrations as a whole, and also guide Epic- and Cerner-specific groups through topics unique to their EMR.

Technical & Informatics ACRP & CBRN CEUs

11:30 am

Grab and Go Lunch

Friday 11:30 am - 12:00 pm

All Attendees