Clinical Trials Research Administration 201(CTRA 201)

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.

To enroll in CTRA 201 please contact SRA International to verify you have previously taken CTRA 101 or to request the CTRA 101 advanced placement test (test requires a $30 administrative fee.)

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

Required Workshop

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

Required Concurrent Session

M305: Research Clinical Trial Compliance

Monday, May 8, 2017 - 2:15pm to 3:30pm

Content level: Advanced

This session will explore clinical trial compliance from a good business, financial and clinical practice. We will distinguish what the risks are associated with clinical trials and how to implement process improvement.

Certificate: CTRA 201-R

Learning objectives:

  1. Identify good business, financial and clinical practice goals.
  2. Implementation opportunities for process improvement.

Prerequisites: None

Speaker(s):

Kelly Willenberg, DBA, MBA, BSN, CHRC, CCRP, CHC, Manager, Kelly Willenberg, LLC

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

Elective Concurrent Session

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

 

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

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