Clinical Trials Research Administration 101 (CTRA 101)

The Clinical Trials Research Administration ("CTRA") series delivers intensive training sessions specifically designed to provide an understanding of the critical elements of successful administration of a clinical trials research program. The program currently has two levels of progressively complex training that must be taken in succession, CTRA 101 then CTRA 201.  Each level introduces the student to a curriculum presenting the body of knowledge required to perform as an accomplished clinical trials research administrator. Satisfying the requirements of the CTRA 101 certificate, or testing out of the CTRA 101 certificate via an advanced placement test, is required prior to taking CTRA 201. Testing out of CTRA 101 will not provide the member with a CTRA 101 certificate.

The CTRA series 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. These elements, along with other relevant issues, will be presented in a combination of one full-day workshop and four sessions for each program.

One (1) workshop and four (4) concurrent sessions (two (2) required sessions; two (2) elective sessions)

Required Workshop

WS8: Guide to Clinical Trials Administration

Sunday, March 18, 2018 - 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. 

Learning objectives:

  1. Identify three milestones in the development of clinical research regulations and describe the importance of each.
  2. Identify three important regulatory differences between clinical research conducted in the US and in non-US/International regions.

Prerequisites: None

Speaker(s):

Bruce Steinert, PhD, CCRA, Director of Clinical Research, Cancer Treatment Centers of America

Required Concurrent Session

M106: It's Your Cost of Doing Business: Clinical Trial Budget Negotiation Challenges

Monday, March 19, 2018 - 9:30am to 10:45am

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.

Learning objectives:

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

Prerequisites: None

Speaker(s):

Vanessa Bryant, Manager, Budget & Finance, University of Utah 

M406: Negotiating Clinical Trial Agreements with For-Profit Companies

Monday, March 19, 2018 - 3:45pm to 5:00pm

Content level: Basic

Tips, traps and tricks of negotiating clinical trial agreements with the industry including a discussion of conducting negotiations via email versus teleconference discussions. I will present scenarios for discussion to illustrate tactics and strategies.

Learning objectives:

  1. Analyze negotiation strategies, identify their individual strengths and weakness and list common mistakes made by negotiators on each side of the table.
  2. Describe the benefits of compromise and tools to help finding it.

Prerequisites: None

Speaker(s):

Casi Morales, JD, Contract Manager, University of Utah

T106: Clinical Trials: What Industry Expects from Research Sites

Tuesday, March 20, 2018 - 9:30am to 10:45am

Content level: Basic

Drug development and the pharmaceutical industry sometimes feels like a black box to those of us in research administration.  We will discuss the timelines of drug development and what drives industry concerns for conduct of clinical trials.  The basics of protocol development and the organizational structure of industry will be presented.  Research infrastructure that is important to a pharmaceutical company will be outlined in a way that sites can be prepared for a site initiation visit and be more successful in obtaining contracts and implementing projects.  

Learning objectives:

  1. Understand the drug development process including pharmaceutical industry drivers.
  2. Understand how a research site is selected and basic contract negotiation topics for clinical trials.

Prerequisites: None

Speaker(s):

Tonya Edvalson, CCRP, CHRC, Clinical Research Compliance Officer, University of Utah

W206: Let's Talk About the Common Rule Revisions: What's It All About?

Wednesday, March 21, 2018 - 10:45am to 12:00pm

Content level: Intermediate

The common rule regulations haven’t been updated in over 30 years. The revisions are intended to modernize how human subjects research is conducted today. Many of the proposed changes will impact the conduct of research operations, from implementation to completion. How are we as research professionals supposed to face the operational challenges that lie ahead in a clear and consistent manner? This session will provide an overview of the proposed changes as well as provide some tips and guidance that can be taken back to the workplace. 

Learning objectives:

  1. Know what the key changes are in the common rule revisions.
  2. Have an understanding of how those revisions will affect them in their workplace. 

Prerequisites: None

Speaker(s):

Carlotta Rodriguez, MS, CIP, CHRC, Director, Rutgers University 

Elective Concurrent Session

M206: Clash of Good Intentions: Integrity and Compliance Issues versus Clinical Trial Operations

Monday, March 19, 2018 - 11:00am to 12:15pm

Content level: Advanced

The primary goals of research in human subjects should always be integrity and patient safety.  What happens in the business world when you are up against contracts, deadlines, and enrollment goals?  There can sometimes be the perception that integrity and compliance requirements get in the way of getting the job done.  This workshop shares the perspectives of individuals from each role: a research integrity official and someone from the clinical trials office.  Our experience in and appreciation for conducting ethical and sound research while meeting contractual requirements, enrollment goals, and study objectives to improve clinical care will be shared with attendees.  We will discuss situations where it appears that integrity and compliance issues will conflict with the operations of a clinical trial and offer solutions.  In a dynamic dialogue, we will all learn together that each paradigm can exist and a clinical trial can be most successfully managed when integrity and compliance issues are imbedded in the day-to-day operations of a research study.  

Learning objectives:

  1. Describe common areas where integrity and compliance requirements are commonly perceived to inhibit successful clinical trial operations.
  2. Identify ways to operationalize these requirements into clinical trial operations to meet ethical considerations, compliance requirements, and good standards in research for a successful clinical trials research program.

Prerequisites: None

Speaker(s):

Tonya Edvalson, CCRP, CHRC, Clinical Research Compliance Officer, University of Utah
Debra Schaller-Demers, MSOM, Director, Research Outreach and Compliance, Memorial Sloan Kettering Cancer Center

M306: Understanding Faculty Approaches to Clinical Research

Monday, March 19, 2018 - 2:15pm to 3:30pm

Content level: Intermediate

The research environment continues to evolve from the early pioneering days of the individual researcher working away in the lab to the more collaborative and out-reaching world of today.  We are also beginning to take a broader look at how research contributes, not only to the clinical disciplines, but also to the patients and the communities we look to serve.  This presentation will offer a researcher’s perspective of the changing landscape of research as it migrates toward greater community engagement research.

Learning objectives:

  1. Enhance understanding of your researchers’ world. 
  2. Gain an appreciation of current research trends toward more community-engaged research.

Prerequisites: None

Speaker(s):

Thomas Oates, PhD, DMD, Professor and Chair, University of Maryland, Baltimore, School of Dentistry

T206: Keeping Up with ClinicalTrials.gov

Tuesday, March 20, 2018 - 11:00am to 12:15pm

Content level: Intermediate

It is scientifically and ethically imperative for researchers to understand key commitments to our research participants to report the results of the clinical trials, so that we can advance knowledge and make informed medical decisions about health care. This session will discuss the most recent federal mandates and requirements of clinical trials disclosure and the best practice. The presenters will share the approach of Rutgers, The State University of New Jersey, to establish an effective program for clinical trials registration and results reporting at their institution. Rutgers’ Human Subjects Protection Program (HSPP) has taken a proactive approach to identify key issues and facilitate investigator compliance within ClinicalTrials.gov records through the HSPP website and continued education and training.  

Learning objectives:

  1. Understand why clinical trials disclosure matters and the key issues of building up an effective program.
  2. Understand how to establish a system in your organization to facilitate and monitor clinical trials registration and results reporting.

Prerequisites: None

Speaker(s):

Cheryl Forst, RN, BSN, CCRP, Director, Rutgers, The State University of New Jersey
Niem-Tzu "Rebecca" Chen, MS, Med, CCRP, Human Subjects Protection Senior Analyst, Rutgers, The State University of New Jersey
 

T306: Should There Be a Policy?

Tuesday, March 20, 2018 - 2:15pm to 3:30pm

Content level: Basic

This presentation will address how standard operating procedures can help or impede work processes for clinical trials.

Learning objectives:

  1. Identify when policies need to be in place.
  2. Identify and introduce best practices.

Prerequisites: None

Speaker(s):

Gayle Walters, MS. Director, Johns Hopkins University

T406: Capitated Budgets: Post-Award Financial Management of Clinical Trial Contracts

Tuesday, March 20, 2018 - 3:45pm to 5:00pm

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.

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):

Vanessa Bryant, Manager, Budget & Finance, University of Utah 

W106: Financial Feasibility Assessment Tools

Wednesday, March 21, 2018 - 9:15am to 10:30am

Content level: Intermediate

Many factors determine the financial and logistical feasibility of clinical research studies. This session provides an overview of standard operating procedure and tools necessary to make this determination, developed from study examples and case studies. Tips on reviewing initial documents such as the proposed contract, sponsor budget, protocol and schedule of events and informed consent in the development of accurate internal cost assessments and cost-benefit analysis will be demonstrated. Vetting and ranking of study trials will be discussed.

Learning objectives:

  1. Review the factors impacting financial feasibility of a clinical research. 
  2. Manage the development of internal cost assessments and cost-benefit analysis.

Prerequisites: None

Speaker(s):

Renee Vaughan, Mdiv, MA, CRA, CRU Financial Practice Manager, Duke University School of Medicine