Clinical Research (CR)

Examines issues relevant to both National Institutes of Health-sponsored and industry-sponsored clinical trials. Much of the material is explored through case studies. Elements of the curriculum include protocol review, recruitment, negotiation of agreements, development and negotiation of budgets, compliance, billing, international studies, and risk management and analysis.

Saturday, May 6, 2017

WS1: Fundamentals of Human Research Protections
Saturday, May 6, 2017 - 9:00am to 5:00pm

Content level: Basic

This workshop includes a basic introduction to the principles underlying human research protections; the regulatory requirements for reviewing, conducting, and overseeing research with human subjects and the current issues facing the research enterprise. This workshop will look at human research protections in a historical context; the regulations that govern research with human subjects; and the structure and requirements of IRBs. Following an overview, the workshop will explore hot topics such as vulnerable populations, COI, noncompliance, among others.

Learning objectives:

  1. To learn the basic concepts regarding the use of human research subjects including the requirements of the Institutional Review Boards (IRBS).
  2. To identify current issues regarding research involving human subjects.

Prerequisites: None

Speaker(s):

Jonathan Hunter, Higher Ed Consulting Manager, Huron Consulting and Maria Soliman, Director, LCI Research Administration, Carolinas HealthCare System

Sunday, May 7, 2017

WS5: Guide to Clinical Trials Administration
Sunday, May 7, 2017 - 9:00am to 5:00pm

Content level: Basic

Clinical trials are a rapidly changing field in research administration. Many of the skills needed to administer more traditional investigator initiated, grant funded research projects can be adapted to managing clinical trials. This teaching workshop will examine the basics of clinical trial administration from recruiting projects to archiving records, explore the differences between industry and federally funded studies, highlight special concerns and discuss best practices for managing clinical trials. A CD of useful documents, links and tools will be provided.

Certificate: CTRA 101-R

Learning objectives:

  1. Identify three milestones in the development of clinical research regulations and describe the importance of each.
  2. Identify three areas of special concern for sponsors, investigators and administrators of clinical research.

Prerequisites: None

Speaker(s):

Bruce Steinert, PhD, CCRA, Director of Clinical Research, Midwestern Regional Medical Center

WS10: The Revitalization of a Clinical Research Office
Sunday, May 7, 2017 - 1:30pm to 5:00pm

Content level: Intermediate

In this presentation, Lisa will share her personal career journey with participants. Lisa joined the University of Wisconsin-Madison, Department of Surgery-Office of Clinical Research (OCR) in March 2015. Lisa started with 3 staff members and has built the OCR team to 11 members currently. OCR has tripled the number of clinical trials activated and has developed streamlined processes for on-boarding new staff, training and professional development. Lisa and Ann will also share how they increased communication among our 200+ faculty members and the critical meetings that are scheduled to ensure transparency. We will also demonstrate how our office has transformed how we track coordinator effort, IRB compliance, and financials. 

Learning objectives:

  1. Evaluate clinical trial office status concerning screening, enrollment, financials, and trial to personnel ratio.
  2. Implement new ideas presented on the process of on-boarding new staff, training, and professional development to create a diverse team of clinical research experts.

Prerequisites: None

Speaker(s):

Lisa Werning, BS, Director of Clinical Research, Department of Surgery and Ann Collura, Clinical Trials Accountant, Department of Surgery, University of Wisconsin-Madison

Monday, May 8, 2017

M106: Clinical Research - Breaking Down the Silos
Monday, May 8, 2017 - 9:30am to 10:45am

Content level: Basic

Performing clinical research involves many detailed steps in order for the entire process to be successful. In many cases, there are several vital groups performing these steps who are working independently of each other within the same organization. This presentation will focus on the lifecycle of a clinical trial and the communication it requires to make that clinical trial a success. Even though every clinical trial requires the services of the same groups (i.e. Principal Investigators, Pre-award Office, Post-award Office, Clinical Trial Coordinators, Research Administration, Institutional Review Board (IRB), Quality Assurance), many times these groups have little to no communication with each other during the process, essentially working in silos. It is vital to each clinical trial that these silos are broken down and the teams learn to communicate effectively with one another. This may mean stepping out their comfort zone and learning to understand the different components to the clinical research study. The open communication will give a solid foundation to the clinical trial as everyone will be working together to do their part. During this presentation, specific focus will be given to examples of missed communication opportunities as well as how to break down the barriers and silos. The attendee will be able to use this information in order make the clinical trial process successful for their site performing the research, the sponsor funding the research, and most importantly, for the patient participating in the research.

Certificate: CTRA 101-E

Learning objectives:

  1. Increase communication across the different workgroups performing a clinical trial.
  2. Increase the success of the clinical trial for their site, the sponsor funding the research and the patient participating in the research.

Prerequisites: None

Speaker(s):

Melissa Baker, MBA, CRA, Associate Administrator, Research, Nemours Children's Health System

M206: Streamlining Your Clinical Trial Contracting by Using the Accelerated Clinical Trial Agreement
Monday, May 8, 2017 - 11:00am to 12:15pm

Content level: Intermediate

Tired of spending so much time and effort negotiating clinical trial agreements (CTAs)? Join us for the ACTA session to discover a rapidly growing initiative that can eliminate the need for negotiation of Industry Sponsored, Clinical Trial Agreements as well as CTAs for federal subcontracts. Commencing in August 2012, the Master Contracts Working Group consisted of 25 CTSA institutions collaborated with industry and the University Industry Demonstration Partnership to develop a standardized clinical trial agreement - a single agreement to be used (voluntarily) by each participating institution and sponsor, to reduce contract negotiations for industry sponsored multi-site studies Clinical Trials. The ACTA has been finalized with over 275 Institutions agreeing that the ACTA terms would be acceptable to their institution. The Federal Subcontracting CTA agreement has just been finalized and is about to begin rollout.

Certificate: CTRA 201-E

Learning objectives:

  1. Be more fully informed of the challenges regarding the Clinical Trial contracting processes.
  2. Have an understanding of the development of and process for using the Accelerated Clinical Trial Agreement.

Prerequisites: None

Speaker(s):

Libby Salberg, Director of the Office of Contracts Management, Vanderbilt and Nickie Bruce, Director, Legal Contract Administration, Mayo Clinic

 

M406: Clinical Trial Budget Negotiation Challenges: It's Your Cost of Doing Business
Monday, May 8, 2017 - 3:45pm to 5:00pm

Content level: Intermediate

Clinical trial budgets are always negotiable. Still, many investigators and clinical teams accept original budgets proposed by industry sponsors. The process of budgetary negotiation may seem intimidating, overwhelming, or ungrateful. In reality, negotiation allows both the sponsor and the site to arrive at a consensus which will benefit both sides. With an acceptable budget the site is more likely to fully commit to subject enrollment and site compliance by allocating proper resources and effort, which will result in producing higher quality data. Trial success can be easily compromised when budgets are negotiated poorly or accepted with no negotiation at all. Who is the right negotiator at the site level? How to muster sufficient negotiation power? When to push back and what to forgo? These and other questions will be addressed in the course of the session. The participants will discuss practical negotiation tips and techniques. Actual budget negotiation examples will be used to reveal most common stumbling blocks between sites and sponsors and the ways to circumvent them.

Certificate: CTRA 201-R

Learning objectives:

  1. Utilize various budget negotiation tips and techniques.
  2. Define the role of budget negotiation in trial success.

Prerequisites: None

Speaker(s):

Pavel Kruchek, MBA, Director, Business Operations, Clinical Trials Office and Vanessa Bryant, Sr. Budget Analyst,  Clinical Trials Office, University of Utah

Tuesday, May 9, 2017

R8: Calculating Exact Effort for Research Staff Conducting Clinical Trials
Tuesday, May 9, 2017 - 8:30am to 9:00am

Content level: Intermediate

At the University of Wisconsin (UW), Clinical Research Coordinator's (CRC's) salaries are typically paid from funded grants or awards in the value or percentage regarding the effort they are proposed to spend working on each clinical trial or project. The challenge with this is that biannually, coordinators are expected to certify this effort. Unfortunately, the exact effort of each CRC is often not accurately applied to the appropriate clinical trials, presenting a scenario in which effort would need to be corrected by salary cost transfers before certification could occur. In order to correct effort on projects, the Accounting office and the Effort Coordinator were often tasked with multiple time-consuming salary cost transfers as well as impending effort certification deadlines. In this presentation, I will demonstrate how UW's Department of Surgery created a system to track the exact effort of CRCs in real-time and to monthly bill each clinical trial/project for real-time effort. The system is composed of a few individual parts. Primarily, the Accounting office set up a revenue producing account (RPA)/pool account in which all of our CRC's salaries are paid from. Each business day, the CRC utilizes a time-tracking program to measure in real-time, the individual clinical trials/projects that they are working on. At month end, each coordinator exports an individual report from the time-tracking program which graphs out the exact effort in hours spent on each individual project. For the Office of Clinical Research (OCR), I developed a calculated fee schedule that captures CRC salary average, fringe rate, paid time off (PTO), administrative costs, and travel stipends in order to calculate an hourly rate for study coordination. (For UW, this is $50/hour.) Using the monthly, number of hours spent on a project multiplied by the CRC hourly fee, each individual clinical trial account is billed to transfer the exact amount back to our RPA/pool account. The effort that CRCs track in a study's activation period (before the individual trial account is set-up) is off-set by the direct cost of the Sponsor's study activation fee also being deposited into the pool account. This system eliminates the need for CRCs to certify effort on any of our funded projects and for OCR to monitor the average amount of CRC effort that should be captured in current and future clinical trial budgets. Another benefit of this system is that we have increased communication and transparency with our faculty/Principal Investigators (PIs) through quarterly financial meetings in which they can assess the monthly effort billed to their clinical trials for accuracy. OCR has been utilizing this new system since July 2015 and it has improved the way we analyze projects in regards to CRC effort, budgeting, and CRC time management and task prioritization. OCR has also shared this concept with other research offices within UW and other departments and offices are beginning to implement this system.                                                                            

Learning objectives:

  1. Conceptualize an example of a system that may assist your institution/clinic in managing CRC effort and salary compensation ensuring integrity to your sponsors.
  2. Create an environment of financial transparency with Principal Investigators/Faculty overseeing the conduction of clinical research and also to use this tool to improve the accuracy of clinical research budgets in the future.

Prerequisites: None

Speaker(s):

Lisa Werning, BS, Director of Clinical Research, Department of Surgery, University of Wisconsin-Madison and Ann Collura, Clinical Trials Accountant, Department of Surgery, University of Wisconsin-Madison

T106: Understanding and Successfully Managing a Clinical Trial
Tuesday, May 9, 2017 - 9:15am to 10:30am

Content level: Basic

The sponsored research portfolio at many large institutions now includes a sizable number of clinical trials whose management is very different from managing basic research project portfolios. In order to effectively manage these complex projects it is important that the research administration team understand all aspects of the clinical trial. In this session we will review the cycle of a clinical trial for both federally funded and industry sponsored clinical research. We will review what a clinical trial is, the different types of clinical trials, Food and Drug Administration (FDA)  trial regulations and the Institutional Review Board (IRB) process before focusing in-depth on the financial management of a clinical trial. Financial management topics covered will include: the contract review process and what to look for in terms and conditions, how to conduct a comprehensive protocol review and identify hidden costs, and the best strategies to develop a robust and accurate budget. We will also cover the key aspects for accurate invoicing and payment recovery. An example of a clinical trial will be used to demonstrate the process.

Certificate: CTRA 101-E

Learning objectives:

  1. Participants will learn the key elements of a clinical trial.
  2. Participants will learn how to develop and manage clinical trial budgets.

Prerequisites: None

Speaker(s):

Rashmi Pershad, M. Phil, Associate Research Administrator and Meagan A. Sok, MPH., Research Administrator, Virginia Commonwealth University

T206: Clinical Trials: The Measurement of Success-Screening, Enrollment, Follow-up and Financials
Tuesday, May 9, 2017 - 10:45am to 12:00pm

Content level: Basic

In this presentation, Lisa and Ann will demonstrate a Microsoft Excel tool that the University of Wisconsin-Madison, Department of Surgery-Office of Clinical Research created and utilizes to monitor all industry-sponsored clinical trials for screening, enrollment, follow-up, financials, and activation status of new research. We will also speak briefly about feasibility and identification of target enrollment for a study and how UW determines this early in the activation process.

Certificate: CTRA 101-E

Learning objectives:

  1. Evaluate the different aspects of their own clinical trials programs in regards to meeting screening and target enrollment goals.
  2. Analyze how screening and enrollment efforts are related to financial and residual status of the project.

Prerequisites: None

Speaker(s):

Lisa Werning, BS, Director of Clinical Research, Department of Surgery and Ann Collura, Clinical Trials Accountant, Department of Surgery, University of Wisconsin-Madison

T306: Clinical Trials: The Industry Perspective
Tuesday, May 9, 2017 - 1:45pm to 3:00pm

Content level: Basic

This is a presentation of the process of drug development from the pharmaceutical industry’s perspective Timelines, quality and cost will be driving factors for discussion. The pharmaceutical industry’s general organizational structure will be introduced. The clinical trial protocol development process and clinical study conduct will be presented. Pharmaceutical drivers for study site selection will be highlighted. Site-based contracts, including budgets, publication rights and intellectual property will also be discussed.

Learning objectives:

  1. Understand the drug development process including pharmaceutical industry drivers.
  2. Understand how sites are selected and contracts are negotiated for clinical trials.

Prerequisites: None

Speaker(s):

 Maria Soliman, Director, LCI Research Administration, Carolinas HealthCare System

T404: Capitated Budgets: Post-award Financial Management of Fixed-price Clinical Contracts
Tuesday, May 9, 2017 - 3:15pm to 4:30pm

Content level: Intermediate

How does managing a fixed-price clinical trial contract differ from a cost reimbursable grant? Even for financial administrators experienced in post-award grant management, capitated budgets may present a challenge. Fixed-price contracts may require a shift in one's perception of and established standards for effort allocation, project periods, budgetary line items, billing procedures, and reconciliation processes. The concepts of flexible budgets, amendable budgets, milestone reimbursements, negotiations with sponsors, flat fees, competitive enrollment, charges vs. costs become a new reality. Recent years show that even National Institutes of Health (NIH) funding is gradually shifting to capitated reimbursement structure for clinical research proposals. In this session participants will utilize sample clinical trial contracts and financial tools to address the differences between fixed-price and cost-reimbursable projects as well as the post-award challenges and the benefits of capitated contracts.

Certificate: CTRA 201-E

Learning objectives:

  1. Define main differences in post-award management of fixed-price contracts and cost-reimbursable grants.
  2. Utilize practical skills in post-award financial management of capitated clinical trial contracts.

Prerequisites: None

Speaker(s):

Pavel Kruchek, MBA, Director, Business Operations, Clinical Trials Office and Vanessa Bryant, Sr. Budget Analyst, Clinical Trials Office, University of Utah

T406: How Can a Financial Navigator Help Your Clinical Patients
Tuesday, May 9, 2017 - 3:15pm to 4:30pm

Content level: Intermediate

How can a financial navigator help clinical trial patients at your site.  A financial navigator is a newer concept to clinical trials.  This role can be utilized to help clinical trial patients understand and navigate the complex world of financials related to trials.  This presentation will outline the role of the position, ways to improve communication with the patient, how to help the clinical trials office and more.

Learning objectives:

  1. How can a financial navigator help your clinical trials program.
  2. Outline roles and responsibilities of the position.

Prerequisites: None

Speaker(s):

Maria Soliman, Director, LCI Research Administration, Carolinas HealthCare System

Wednesday, May 10, 2017

W106: Collaborative Research and the Role of the Scientist in Society
Wednesday, May 10, 2017 - 9:00am to 10:15am

Content level: Intermediate

A variety of collaborative relationships in research amongst academia, industry, government and society result in different roles for the researcher. Whether viewed as a "discoverer of new knowledge”, an “independent authority”, or a “deliverer of tangible goods”, researchers often face conflicting agendas while striving to ensure scientific objectivity and ethical decision-making in their work. Research Administrators can become more effective and productive in their work and interactions with researchers by better understanding these differing roles and dynamics. This presentation will discuss some of these conflicting agendas, the different roles of researchers, how the practice of science is affected, and how the training of new researchers and staff members are impacted. NOTE: Use of an electronic audience response system will further engage participants and foster discussion of this interesting topic.

Learning objectives:

  1. Attendees will gain a better understanding of a variety of ethical issues encountered by researchers from collaborative relationships between academia, industry, government and society.
  2. Attendees will be better able to identify and respond to the tensions, challenges and expectations researchers face in different collaborative relationships in science.

Prerequisites: A basic working knowledge and fundamental understanding of conflicts of interest and commitment in the research setting.

Speaker(s):

Tony Onofrietti, M.S., CRSS, Director, Research Education, The University of Utah

W105: Negotiating Clinical Trial Agreements with For-Profit Companies
Wednesday, May 10, 2017 - 9:00am to 10:15am

Content level: Basic

This session includes a basic introduction to the process of negotiating with for-profit companies. It will also include strategies on avoiding pitfalls in budgetary and non-budgetary contract terms. The primary objectives are:

1) Identify Primary Differences Between For-Profit Agreements vs. Non-Profit Agreements
2) Negotiate Common Areas of Conflict
3) Review Budget Items and Payment Terms

Certificate: CTRA 101-R

Learning objectives:

  1. Identify Primary Differences Between For-Profit Agreements vs. Non-Profit Agreements.
  2. Negotiate Common Areas of Conflict.

Prerequisites: None

Speaker(s):

Vanessa Bryant, Sr. Budget Analyst, Clinical Trials Office and Tara Merrill, Contracts Officer, University of Utah

W206: Coverage Analysis, Budget, Clinical Trial Management System… What’s the Connection
Wednesday, May 10, 2017 - 10:30am to 11:45am

Content level: Intermediate

Have you ever wondered how a coverage analysis, budget and clinical trial management system fit together?  This presentation will discuss the needs for all three areas.  It will explore how each build on the other and how it can create efficiency for patient billing.

Certificate: CTRA 201-E

Learning objectives:

  1. Understand the interconnection between a coverage analysis, budget and clinical trial management system.
  2. Understand the downstream effect on patient billing and how it helps create efficiencies. 

Prerequisites: None

Speaker(s):

Stephen Baldwin, Director, Sponsored Programs Administration, Carolinas HealthCare System