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

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

Required Concurrent Session

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

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

Elective Concurrent Session

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

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