Agenda

The focus areas for the 2020 Spring Onsemble conference include:

  • Data / Analytics
  • Executive / CTO Leadership
  • Financials
  • Regulatory
  • Technical
  • Training / Adoption / Implementation

Monday, March 16, 2020

9:00 am

Workshop: OnCore 101

Monday 9:00 am - 3:00 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! Senior Training Specialist Stephen Shapiro will walk trainees through the quick wins and interesting features of OnCore including task lists, protocol search, subject visit management and sponsor invoicing. This session is a great opportunity to get answers to all of your OnCore questions! Lunch will be included with this workshop, you do not need to register for Monday's lunch.

All Attendees ACRP CEUs

11:30 am

Lunch

Monday 11:30 am - 1:00 pm

All Attendees

3:00 pm

Speakers:

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

Monday 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. This session will be most beneficial to new/prospective customers or those who are new to their organization.

All Attendees ACRP CEUs

6:00 pm

Welcome Dinner

Monday 6:00 pm - 8:00 pm

Join us as we kick off the conference with a poolside dinner reception!

All Attendees

Tuesday, March 17, 2020

6:15 am

Morning Yoga

Tuesday 6:15 am - 7:00 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

Tuesday 7:30 am - 8:30 am

All Attendees

8:30 am

Speaker:

Keynote

Tuesday 8:30 am - 9:30 am

Devon Still is a former professional athlete, author, top resiliency expert, motivational speaker, and advocate for childhood cancer awareness. Still will speak about his daughter’s experience beating cancer and how he has overcome challenges in his own life to find success and share his message of hope and inspiration with others.

All Attendees

9:45 am

General Session

Tuesday 9:45 am - 10:45 am

In this general session, members of the Advarra-Forte leadership team will share company updates and the shared vision for the future.

All Attendees

11:00 am

Speakers:

From Caveman to Spaceman! A Successful Evolution and Integration of OnCore & Epic

Tuesday 11:00 am - 11:50 am

The University of Florida implemented interfaces between OnCore and Epic through a progressive evolution of research technology, workflow adoption and end-user training. This process began with the implementation of an ADT interface for subject registration, followed by the RPE interface, and ended with the addition of the CRPC interface. As our technologies evolved, it was evident that our workflows, communications, and training needed to evolve as well. This presentation, led by Melissa Sykes and Paticia Stamm of UF, will outline their process and pathway for designing a training and communication strategy for these changes that is workflow-focused rather than application-focused.

Training / Adoption / Implementation ACRP, CBRN & SoCRA CEUs

Speakers:

(Workshop/Triple Session): Getting the Most out of Forte Insights

Tuesday 11:00 am - 2:50 pm

This hands-on workshop, led by Advarra-Forte's Wendy Tate, Director of Research Operations and Blake Taylor, Product Manager, is intended for current Insights users to become more familiar with how they can leverage Insights at their organization. Various use cases regarding accrual towards protocol and organizational goals, financial collections and activation cycle times will be explored, and users will be able to walk through the exercises and evaluate their own data. Attendees are required to have their own laptop and ability to log in to their organization's instance of Forte Insights.

Data / Analytics ACRP, CBRN & SoCRA CEUs

Speakers:

Optimization of Financial Management and the Trial Lifecycle

Tuesday 11:00 am - 11:50 am

Yale Center for Clinical Investigation (YCCI) established a centralized unit to handle the post-award activities for clinical trial accounts receivable (AR) for Industry-sponsored research in clinical departments. This process was piloted by Internal Medicine, Digestive Diseases with the transition of budget development and post-award financial management activities. The pilot was a success, resulting in the on-boarding of the other divisions of Internal Medicine and has expanded to support all other clinical departments. In this session, Kelly Anastasio and Patricia Fontaine will outline the processes and tools YCCI developed to manage this process across the organization.

Financials ACRP, CBRN & SoCRA CEUs

12:00 pm

Lunch

Tuesday 12:00 pm - 1:00 pm

All Attendees

1:00 pm

Speaker:

(Workshop/Triple Session Cont'd): Getting the Most out of Forte Insights

Tuesday 1:00 pm - 2:50 pm

This is a continuation of the Getting the Most out of Forte Insights session. If you would like to attend this session, please see the 11:00am timeslot to add it to your agenda.

Data / Analytics ACRP, CBRN & SoCRA CEUs

Speaker:

Navigating Institutional Risk in CTA/Budget Negotiations

Tuesday 1:00 pm - 1:50 pm

Most institutions and clinical investigators are well aware of the regulations that govern Good Clinical Practice in clinical trials and have SOPs and internal guidance on how to comply. However, there are other federal rules and regulations governing financial and legal aspects of clinical trial contracts and budgets that impose significant risk for the unwary. In this session, Robert Romanchuck, IRB Chair at Advarra, will discuss the implications of the False Claims Act, Anti-Kickback Statute, Stark Rule and Medicare Secondary Payer Rule on CTA and Budget negotiation. He will provide practical guidance targeted at research managers charged with CTA/Budget negotiation.

Financials ACRP, CBRN & SoCRA CEUs

Speakers:

  • Molly Van Rheen, MS MBA
    CTMS Program Director, Fred Hutch Cancer Research Center, University of Washington, and Seattle Cancer Care Alliance
  • Kate Fiorito
    Staff Augmentation, Advarra/Forte

Creating and Maintaining an OnCore QC Program

Tuesday 1:00 pm - 1:50 pm

Molly Van Rheen, the CTMS Program Office Director at the University of Washington, Fred Hutchinson Cancer Center, and Seattle Cancer Care Alliance, and Kate Fiorito of Forte’s Staff Augmentation team will discuss how UWFHSCCA created and implemented their QC Program. After a successful implementation of OnCore, UWFHSCCA identified a need to implement a standardized process for confirming Minimum Footprint compliance and flagging logic errors for protocols and subjects. UWFHSCCA used Forte’s Staff Augmentation service to supplement their existing staff for this effort. Molly and Kate will discuss how legacy data was reviewed and prioritized, how the team moved from back-data and QC ramp up cleaning to real time data monitoring, how UWFHSCCA implemented technical solutions to help make the process more efficient, and how the QC efforts inform operational changes.

Training / Adoption / Implementation ACRP, CBRN & SoCRA CEUs

Speaker:

(Double session) Managed Infrastructure: Info Session and Office Hours

Tuesday 1:00 pm - 2:50 pm

In this session, Jason Jaszewski, Director of IT at Advarra-Forte, will provide attendees with an informative review of Managed Infrastructure. Topics include overviews of Managed Infrastructure and the transition process, progress to date and customer experiences. The second half of this double session will be “office hours” format for open Q&A and discussion about Managed Infrastructure. Attendees may also schedule a block of time during this session for one-on-one discussion with a Managed Infrastructure expert to discuss specifics for their organization.

Technical ACRP CEUs

2:00 pm

Speaker:

Privacy Considerations in Research: the Changing Landscape

Tuesday 2:00 pm - 2:50 pm

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). What impact does digital technology (Apple Watch, Fitbit, Alexa), as well as apps that can be downloaded onto tablets, computers or iPhones, have on this definition? Do we need to reconsider what is commonly accepted as private information in this age of vast information gathering through ever evolving technology? In this session, Michele Russel-Einhorn of Advarra will examine concepts of privacy and confidentiality, identify situations that impact the ability of an investigator or an IRB to protect privacy and confidentiality, and propose solutions to address some of these challenges.

Regulatory ACRP, CBRN & SoCRA CEUs

Speaker:

(Double Session Cont'd) Managed Infrastructure: Info Session and Office Hours

Tuesday 2:00 pm - 2:50 pm

This is a continuation of the Managed Infrastructure: Info Session and Office Hours session. If you would like to attend this session, please see the 1:00pm timeslot to add it to your agenda.

Technical ACRP CEUs

Speakers:

  • Christine Ricklefs, MPH
    OnCore Calendar Builder Program Manager, University of Colorado, Anschutz Medical Campus
  • Kirk Hohsfield, BA
    BSM Administrator and OnCore Calendar Builder Team Lead, University of Colorado Anschutz Medical Campus

Optimizing Financial Builds for All Funding Sources

Tuesday 2:00 pm - 2:50 pm

During this presentation, Christine Ricklefs of The University of Colorado Anschutz will share her expertise on a centralized OnCore financial build workflow for all funding sources, including industry, IIT, federal, cooperative group, and multiple sponsors. She will also discuss how CU Anschutz incorporates specific department needs for financial tracking into their standardized financial build process while maintaining consistency across their multi-institutional organization.

Financials ACRP, CBRN & SoCRA CEUs

Speaker:

(Workshop/Triple Session Cont'd): Getting the Most out of Forte Insights

Tuesday 2:00 pm - 2:50 pm

This is a continuation of the Getting the Most out of Forte Insights session. If you would like to attend this session, please see the 11:00am timeslot to add it to your agenda.

Data / Analytics ACRP, CBRN & SoCRA CEUs

3:00 pm

Progress and Plans Keynote

Tuesday 3:00 pm - 4:00 pm

Hear from Onsemble community members about how they leverage Forte solutions at their organizations to enhance regulatory compliance, improve study startup timelines and streamline research operations.

Chief Product Officer James Wurdeman will also share progress and plans for Forte products and services.

All Attendees

4:00 pm

Product and Services Happy Hour

Tuesday 4:00 pm - 5:30 pm

All Attendees

Wednesday, March 18, 2020

6:15 am

Morning Yoga

Wednesday 6:15 am - 7:00 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

Speakers:

Annual Review and Audit Preparedness for Clinical Research Systems - Part 1

Wednesday 8:30 am - 9:20 am

Ensure that your clinical research systems are ready for external audit. Join Shannon Roznoski and MaryAnn Kempker of Advarra-Forte for a discussion of annual activities to support continued use of your clinical research systems including process audits and SOP reviews. Part 2 will explore additional considerations for 21 CFR Part 11 validated systems.

Regulatory ACRP, CBRN & SoCRA CEUs

Speakers:

  • Kate Weber
    Clinical Research Applications Administrator, George Washington University Cancer Center
  • Richard Lush
    Director, Clinical Trials Office, George Washington Cancer Center

OnCore Implementation Within a Developing Cancer Center

Wednesday 8:30 am - 9:20 am

In this session, Kate Weber and Rich Lush of the George Washington University Cancer Center, will review their OnCore implementation experience. The Cancer Center implemented OnCore using a small team (2) while collecting input from internal leadership and subject matter experts (SMEs). The implementation within the Cancer Center was the first step to a planned implementation within the university system, so special consideration was taken to ensure that their decisions would support the further implementation planned after the Cancer Center go-live. They will discuss the strategies that allowed their team to quickly go-live, while also discussing the challenges they faced.

Training / Adoption / Implementation ACRP, CBRN & SoCRA CEUs

Speaker:

Planned Visit Reconciliation with Tableau Dashboard

Wednesday 8:30 am - 9:20 am

At Memorial Sloan Kettering, OnCore calendar usage has been implemented across departments via a phased rollout starting in April 2017. Currently, they have around 700 active calendar users, and the importance of timely data entry and visibility is paramount. They have implemented a Tableau dashboard based initially on OnCore’s Planned Visit/Subject Visit Details Report to assist users with their planned visit reconciliation process. In this session, Benjamin Search, CTMS Analyst, will share how MSK has been using functionality in the Tableau dashboard to assist users with their day to day data entry.

Data / Analytics ACRP, CBRN & SoCRA CEUs

9:30 am

Speaker:

Meeting the Challenges of Clinical Research in the Community Health System Setting

Wednesday 9:30 am - 10:20 am

The operational challenges of clinical research are well-known in the Academic Medical System setting, and elaborate resources are provided to support it. This is not often the case in the Health Care System setting where clinical research may not be considered among its primary missions. Challenges related to infrastructure, centralized leadership and management, physician compensation and compliance are daunting. In this session, Rob Romanchuk, IRB Chair at Advarra, will provide an overview of the many challenges facing health systems engaged in clinical research and how these various challenges can be met to allow clinical research to succeed.

Executive / CTO Leadership ACRP, CBRN & SoCRA CEUs

Speakers:

Annual Review and Audit Preparedness for Clinical Research Systems - Part 2

Wednesday 9:30 am - 10:20 am

In part 2 of the Annual Review and Audit Preparedness for Clinical Research Systems session, Shannon Roznoski and MaryAnn Kempker of Advarra-Forte take an in-depth look at additional annual review activities based on regulatory and industry guidance recommendations for 21 CFR Part 11 validated systems, including audit trail reviews and validation and change control documentation.

Regulatory ACRP, CBRN & SoCRA CEUs

Speakers:

  • Julie Anthony
    Business Analyst, OnCore CTMS, University of Michigan Health Information Technology & Services
  • Kristen Matta
    Business Systems Analyst, University of Michigan

Ready, Set … Finance! Gamifying OnCore to Spark Understanding

Wednesday 9:30 am - 10:20 am

Since the University of Michigan’s go-live in 2017, finance teams have played a critical role in supporting our organizational goal of centralizing the financial management of UMICH clinical trials and research within OnCore. After three years of actively embracing continuous change, trends in frequent questions and repeat support issues prompted the launch of an initiative aimed at boosting the overall comprehension of complex OnCore scenarios (as well as common FAQs) via gamification. In this session, Kristen Matta and Julie Anthony will discuss the principles behind the “Onkoretoberfest!” initiative and share their experiences with this and other creative approaches taken to engineer positive experiences for end-users in order elevate teams’ confidence as their continue to grow a culture of excellence.

Training / Adoption / Implementation ACRP, CBRN & SoCRA CEUs

10:30 am

Speakers:

Modernizing Clinical Research Staff Roles & Career Tracks

Wednesday 10:30 am - 11:20 am

Implementing advanced clinical research technology can be challenging. It also presents opportunities to modernize traditional research infrastructure, staff roles and career tracks for longterm development, retention and success. In this session, Denise Snyder of Duke University and Bishoy Anastasi of UCLA will discuss their strategies and experiences in successfully adapting and developing their workforce in light of their OnCore implementations.

Executive / CTO Leadership ACRP, CBRN & SoCRA CEUs

Speakers:

Regulatory Fine Points: A Panel Discussion

Wednesday 10:30 am - 11:20 am

In this session, James Riddle of Advarra along with MaryAnn Kempker and Stuart Cotter from Advarra-Forte, will review how the partnership between software vendors and research institutions works to support regulatory guidelines. The panel will discuss, in detail, what parts each party is responsible for when building, implementing, and maintaining clinical trials software in a governmental regulated process.

Regulatory ACRP, CBRN & SoCRA CEUs

Speaker:

eLearning on a Budget

Wednesday 10:30 am - 11:20 am

eLearning is a great way to add some variety to your training while also reaching a wide audience in a convenient way. But what are your options when personnel and software licenses don't leave you much room in your budget to dedicate to eLearning development? In this session, Tim Spinler, Senior eLearning Developer at Advarra-Forte, will review some economical solutions you can use to add eLearning to your training repertoire, including some tools you probably already use.

Training / Adoption / Implementation ACRP, CBRN & SoCRA CEUs

11:30 am

Lunch

Wednesday 11:30 am - 1:00 pm

All Attendees

1:00 pm

Speakers:

  • Amanda Childs
    OnCore Program Manager, University of Colorado, Denver | Anschutz Medical Campus
  • Marissa Macri
    Senior Project Manager, UCHealth

(Double Session) You're in OnCore, Now What? Leveraging Your Integrations for Accountability

Wednesday 1:00 pm - 2:50 pm

In this session, Amanda Childs of CU Anschutz and Marissa Macri of UCHealth will share their philosophy for keeping study teams accountable to using OnCore. They will share their successes and lessons learned, 14 months after University of Colorado, Anschutz and UCHealth jointly implemented interfaces with Epic. They will discuss their well-developed collaborative processes, reports, training tools for auditing, and how to evaluate end-user use. They will also share how their institutions are leveraging Insights for end-user buy-in to OnCore.

Training / Adoption / Implementation ACRP, CBRN & SoCRA CEUs

Speakers:

(Double Session) How to Survive an Acquisition and Keep Your Research Program Running

Wednesday 1:00 pm - 2:50 pm

Consolidation in the health care space is accelerating at a rapid pace. Whether you are the acquirer or the acquired, research program integration has a tendency to get overlooked in the broader organizational and care delivery integration process. Merging research programs can be tricky, and research administration leaders need to prepare. In this session, James Riddle of Advarra and Wendy Tate of Advarra-Forte will discuss successful integration strategies from techniques to learning about your new partners to change management and how to operationalize those changes without disrupting research or funding. They will also explore key pitfalls from those who have journeyed down this path before.

Executive / CTO Leadership ACRP, CBRN & SoCRA CEUs

Speaker:

Train Your End Users in Forte's LMS

Wednesday 1:00 pm - 1:50 pm

The Forte Training Team wants you to take advantage of the content and resources available in Forte Academy to expedite your end-user training program. Our eLearning, webinars and videos are available at no cost to our customers, and we have increased our content library by 25% in 2019 in order to provide the greatest value to staff at your organization. In this session, Tim Spinler, Sr. eLearning Developer at Advarra-Forte, will illustrate the tools and functionality of Forte Academy that can be used to support your end-user training (including user management, training assignments, and reporting) and provide some strategies for incorporating Forte-created content into your training program.

Training / Adoption / Implementation ACRP CEUs

2:00 pm

Speakers:

  • Amanda Childs
    OnCore Program Manager, University of Colorado, Denver | Anschutz Medical Campus
  • Marissa Macri
    Senior Project Manager, UCHealth

(Double Session Cont'd) You're in OnCore, Now What? Leveraging Your Integrations for Accountability

Wednesday 2:00 pm - 2:50 pm

This is a continuation of the You're in OnCore, Now What? Leveraging Your Integrations for Accountability session. If you would like to attend this session, please see the 1:00pm timeslot to add it to your agenda.

Training / Adoption / Implementation ACRP, CBRN & SoCRA CEUs

Speaker:

  • Brian Williams
    Clinical Trials Management System (CTMS) Analyst, Memorial Sloan Kettering Cancer Center

End User Trainings: Lessons Learned Over Time

Wednesday 2:00 pm - 2:50 pm

Since implementing OnCore in 2017, Memorial Sloan Kettering has encountered some unique challenges in training 1900+ end-users with various responsibilities on the tasks they need to complete in OnCore. In this session, Brian Williams, System Analyst, will share MSK's experiences and evolution of training tools. The focus will be on the initial training prior to implementation of the system, iterations of trainings over time and current best practices involving online presentations/quizzes and in-person system use in a training environment.

Training / Adoption / Implementation ACRP, CBRN & SoCRA CEUs

Speakers:

(Double Session Cont'd) How to Survive an Acquisition and Keep Your Research Program Running

Wednesday 2:00 pm - 2:50 pm

This is a continuation of the How to Survive an Acquisition and Keep Your Research Program Running session. If you would like to attend this session, please see the 1:00pm timeslot to add it to your agenda.

Executive / CTO Leadership ACRP, CBRN & SoCRA CEUs

3:00 pm

Speakers:

  • Melissa Lingis, PhD, CCRP
    Clinical Trials Lead, Pediatric Research Hub, University of Florida, Pediatric Research Hub
  • Rebeccah Mercado
    Clinical Research Manager, University of Florida, Pediatric Research Hub

Change Agent: Using OnCore to Build Trust

Wednesday 3:00 pm - 3:50 pm

In 2017, The Department of Pediatrics at the University of Florida began the Pediatric Research Hub (PoRCH), a centralized research hub that provides coordinated research infrastructure and support to faculty within the department. With the use of OnCore, and continued engagement with the Office of Clinical Research, the PoRCH has been able to navigate through changes in the department as well as the institution. OnCore has become an invaluable tool for creating consistency and building trust. During this presentation, Melissa Lingis and Rebeccah Mercado will share how they work with their IRB and OCR to ensure timely startup, the integration of coverage analysis and use tools within OnCore to record important information vital to the success of their studies and continued growth of research.

Technical ACRP, CBRN & SoCRA CEUs

Speakers:

Lessons Learned from Implementing OnCore and eReg Simultaneously

Wednesday 3:00 pm - 3:50 pm

In this session, speakers from Inova Health System will discuss the decision-making and processes behind their simultaneous OnCore and eReg implementations. They will also discuss how their process was organized, why they decided to implement eReg before OnCore and how they made it work.

Training / Adoption / Implementation ACRP, CBRN & SoCRA CEUs

Speaker:

  • Brett Weaver
    CTMS Trainer and Customer Experience Analyst, University of Minnesota

Configuring Multi-Site Studies in OnCore

Wednesday 3:00 pm - 3:50 pm

In this session, Brett Weaver, CTMS Trainer and Customer Experience Analyst at the University of Minnesota, will provide an overview of multi-site capabilities and tracking within OnCore including setup, maintenance and follow-up. He will also discuss reports and exports used for the studies, training processes for coordinating and affiliate sites, and financial components of UMN's multi-site studies.

Technical ACRP, CBRN & SoCRA CEUs

4:00 pm

Speaker:

SCDM eSource Implementation Consortium Information Session

Wednesday 4:00 pm - 4:30 pm

The Society for Clinical Data Management (SCDM) eSource Implementation Consortium provides a unique forum for sites and sponsors to work together and share lessons learned in the wider industry. In this half-session, consortium member Shannon Roznoski, Director of Product Management at Advarra-Forte, will speak about what the consortium is, what it does, who the current members are, and how your organization can participate.

Executive / CTO Leadership

Speakers:

  • Anna Grant, RRT
    Manager, PRMS and OnCore Oncology, University of Nebraska Medical Center
  • Katie Penas
    Clinical Research Manager, Nebraska Medicine

Leveraging OnCore to Separate IRB and Institutional Requirements

Wednesday 4:00 pm - 4:50 pm

You've developed workflows, trained end-users and successfully implemented the CTMS. What happens when the IRB separates their approval criteria from institutional requirements, and changes the entire process and timeline? Learn from Katie Penas and Anna Grant from the University of Nebraska Medical Center/Nebraska Medicine as they walk through workflow development, testing and regulatory documentation in order to leverage OnCore to support major workflow changes.

Regulatory ACRP, CBRN & SoCRA CEUs

Speaker:

OnCore Upgrades and What’s the Value of Being an Early Adopter?

Wednesday 4:00 pm - 4:50 pm

As Forte frequently releases new versions of their software, this session led by Jeff Parks, Product Manager at Advarra-Forte, will explore the reasons why being an early adopter can be a great way to be a thought leader and help shape the direction of development of future versions of software.

Training / Adoption / Implementation ACRP CEUs

Speaker:

End-Users & U: Providing Quality End-User Documentation

Wednesday 4:00 pm - 4:50 pm

In this session, Sr. Training Specialist Stephen Shapiro will walk attendees through Forte's approach to writing high-quality guidance documents. He will discuss strategies for eliminating the "wall of text" feeling that can sometimes happen with documentation and how to help guide users to pertinent information with tasteful use of annotated screenshots, tables and bulleted lists.

Training / Adoption / Implementation ACRP, CBRN & SoCRA CEUs

6:00 pm

Final Night Dinner

Wednesday 6:00 pm - 10:00 pm

Join us at the famous TPC Sawgrass Golf Club for drinks, dinner and entertainment. Transportation will be provided to and from the event. With the Players Championship taking place just days prior, this is a evening that can't be missed!

All Attendees

Thursday, March 19, 2020

7:30 am

Breakfast

Thursday 7:30 am - 8:30 am

All Attendees

8:30 am

Integration of OnCore into the Data Delivery Process

Thursday 8:30 am - 9:20 am

In this session, Deanna Guthrie at the University of Alabama Birmingham, will describe the integration of OnCore data into the institutional tools and process within the Enterprise Data Warehouse to improve the efficiency and capability of supporting institutional research needs, including enrollment data for validating the appropriate population based on current enrollment status.  Additionally, she will share how research personnel identify patient populations of interest based on data from clinical operations and specific research data from OnCore.

Data / Analytics ACRP, CBRN & SoCRA CEUs

Speaker:

How to Prepare for and Respond to an FDA Inspection

Thursday 8:30 am - 9:20 am

Current FDA BMIO metrics indicate that about 27% of FDA inspections result in the issuing of an FDA form 483. Based on the response to this 483, the FDA may or may not issue a Warning Letter if the response is not adequate. In either case the impact on the research site or institution can have profound negative consequences. It is paramount that investigator sites understand well how to prepare well for FDA inspections to avoid a 483 and how to respond adequately if one is issued. This session, led by Robert Romanchuk, IRB Chair at Advarra, will provide practical guidance for both preparation and response to FDA inspections.

Regulatory ACRP, CBRN & SoCRA CEUs

9:00 am

Coverage Analysis Workshop™

Thursday 9:00 am - 5:00 pm

This 2-day (Thursday and Friday), 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 Thursday evening.

Financials

9:30 am

Speakers:

  • Michele Seliga
    CTMS Study and Support Analyst, University of Minnesota
  • Diana Jin
    OnCore Trainer and Support, University of Minnesota

OnCore All Access! An All-Access Discussion about Access

Thursday 9:30 am - 10:20 am

The University of Minnesota recently upgraded OnCore and is in the process of developing new access roles utilizing the stacked roles functionality. Their new approach allows them to enhance customization of end-user access, as well as significantly decrease administrative burden. In this discussion-based session, Michele Seliga and Diana Jin will highlight the benefits and challenges of developing access roles with the new layered privileges. They will also review all aspects of OnCore access, including the university's OnCore access approval workflow, user validation and maintenance.

Technical ACRP, CBRN & SoCRA CEUs

Speaker:

(Double Session) Leverage OnCore for Vendor Payables

Thursday 9:30 am - 11:20 am

The OnCore Vendor Payables feature allows you to track and manage payments made by your organization to vendors (internal departments or external vendors that provide services for the protocol or subject visits). In this session, presenters from Advarra-Forte will describe the Vendor Payables functionality as well as identify the application and implementation tools to assist you with using this feature at your organization. Presenters will also discuss Forte's implementation recommendations.

Financials ACRP CEUs

Speakers:

  • Cheryl Byers
    Director, PRMS and Regulatory Affairs, Moffitt Cancer Center
  • John Musser
    Director of the Clinical Trials Business Office, Moffitt Cancer Center

Streamlining your Budget, Contract and Regulatory Processes for Study Activation: Myths and Legends

Thursday 9:30 am - 10:20 am

Institutions often face difficulty aligning all of the elements of study start up to ensure timely activation of clinical trials. In this session, John Musser and Cheryl Byers of Moffitt Cancer Center share best practice for streamlining processes within a clinical trials business office and regulatory affairs.

Executive / CTO Leadership ACRP, CBRN & SoCRA CEUs

10:30 am

Speaker:

(Double Session Cont'd) Leverage OnCore for Vendor Payables

Thursday 10:30 am - 11:20 pm

This is a continuation of the Leverage OnCore for Vendor Payables session. If you would like to attend this session, please see the 9:30am timeslot to add it to your agenda.

Financials ACRP CEUs

Speaker:

Demystifying FDA Part 11 Regulations and Preparing Institutions for Compliance

Thursday 10:30 am - 11:20 am

FDA is placing increased emphasis on compliance with 21 CFR Part 11. Institutions, Health Systems, IRB offices, private research clinics, application developers (to name a few) need to understand the basics of the regulation and how to comply. This session will address common misconceptions about Part 11 and cover how to practically prepare for an eventual FDA Part 11 inspection. Using a Part 11-compliant vendor for your software is a start, but not the end of the journey to compliance. It is important for institutions to be aware of this somewhat forgotten regulation and its potential impact on research. By increasing understanding of regulations impacting the clinical research environment, institutions and others can have a better appreciation of the regulatory landscape and help design programs accordingly.

Regulatory ACRP, CBRN & SoCRA CEUs

11:30 am

Lunch (Grab & Go Available)

Thursday 11:30 am - 12:00 pm

All Attendees

Friday, March 20, 2020

9:00 am

Coverage Analysis Workshop™

Friday 9:00 am - 5:00 pm

Financials