UAMS.EDU

Webinars

Applied Clinical Trials Webinar (Host)

“Improving Clinical Trial Transparency, Collaboration and Efficiencies”
Date: Wednesday, March 29, 2017
Time: 10:00 AM – 11:00 AM CST
Location: College of Public Health G226

Overview

Premier Research, a Contract Research Organization (CRO), faced two key challenges related to process and system variability across customers, which were attributed to different trial management systems, various trial and site monitoring report templates, and varying trial oversight requirements, among others. This discussion will explore how Premier turned these challenges into an opportunity to drive innovation, combining data analytics with modern CTMS capabilities to simplify complex processes, automate information sharing, and improve sponsor collaboration.

Speakers

Brion Regan has nearly 15 years of industry experience and is an expert in the application of data-driven process optimization and cloud-based technologies in the clinical research space. As Product Manager for ERT’s Trial Oversight Suite, he leads the commercial development and management of the company’s growing portfolio of Software-as-a Service (SaaS) solutions. Prior to ERT, Regan served on the executive leadership team at technology start-up eClinical Insights as Head of Strategic Development. He previously held positions in product marketing and business development at PharmaPros Corporation.

Andrea Ochoa has over 15 years of CRO experience. Having held several positions during her career Andrea brings a strong global experience in areas such as regulatory and study start up, successful projects implementation and execution and processes development.

1 CRS credit hour

Click here to register via Training Tracker


Life Science Training Institute (Host) 

“Understanding The New NIH/HHS Final Rule On Clinical Trial Reporting – Tips for Compliance Success”
Date: Thursday, April 6, 2017
Time: 12:00 PM – 1:30 PM
Location: College of Public Health 3202

Overview

The recent changes in National Institutes of Health/Health and Human Services (NIH HHS) requirements (Final Rule) for registration of clinical trials and submission of results information will apply to all clinical trials of medicinal products (including Biologics) and device products.  This Final Rule clarifies and expands the requirements for registration and submission of data from clinical trials.  The Final Rule also outlines the potential civil or criminal actions which may be taken by the regulatory agency for non-compliance.

This final rule is a mandatory piece of your clinical studies that, if ignored, will irreparably harm or even destroy your trials.  Fortunately, we have broken down the final rule into a digestible, convenient format that will put you and your studies on the road to compliance.

During this presentation, you will learn:

  • The requirements set forth in the new Final Rule to enable you to prepare yourself for compliance
  • Who the “responsible party” is
  • The new required format for protocol submission
  • The new formats for reporting clinical trial results and adverse events
  • The current timeframes for registering and updating ClinicalTrials.gov

1.5 CRS credit hours

Click here to register via Training Tracker


PRIM&R (Host) 

“Studying Effectiveness: Ethical and Regulatory Considerations in Pragmatic Clinical Trials”
Date: Wednesday, April 26, 2017
Time: 12:00 PM – 1:30 PM
Location: College of Public Health G232

Overview

When multiple options exist for treating the same condition, it is not always known which is best. Pragmatic clinical trials (which can include comparative effectiveness research studies) are designed to answer such questions. These trials evaluate the effectiveness of interventions under real-life, routine practice conditions.

But conducting research in “real-life, routine practice conditions” presents challenges for research design as well as for IRB oversight. It can also sometimes blur the distinction between research and clinical care. The challenges that IRBs face with pragmatic trials may not be new, but they are perhaps more complex than the issues typically raised by other types of research studies. During this intermediate-level webinar, presenters will:

  • Provide an introduction to pragmatic trials: what they are and how to recognize them
  • Explore some common areas of ethical and regulatory importance for IRBs when reviewing pragmatic clinical trials, including distinguishing clinical care from research and from QA/QI; informed consent; risk determination; and the nature of interventions
  • Describe some strategies that may be useful in addressing these issues

After this presentation, you will be able to:

  • Define and recognize pragmatic clinical trials
  • Understand some of the primary ethical and regulatory issues associated with them
  • Describe some of the specific considerations for IRB review when it comes to pragmatic clinical trials

1.5 CRS credit hours

Click here to register via Training Tracker


Association for Clinical Research Professionals

“Return of Research Results to Participants: Ethical & Operational Challenges”
Date: Wednesday, May 24, 2017
Time: 11:00 AM – 12:00 PM
Location: College of Public Health G228

Overview

Sharing research results has been universally accepted as a need and duty toward research participants. Current regulatory trends will soon make it routine for our industry. This session will provide an update on the current regulations, guidance and international effort toward sharing research results with participants. Each member of the research team will be called upon to anticipate how their role will evolve to accommodate this important step in the research process with practical ways to implement the sharing of research results with the most important member of the research team – volunteer participants.

Speaker, Robert Romanchuk, is currently Vice-Chair at Schulman IRB and has 2 decades of experience in research operations and human subjects protections. His achievements include building and managing a central research operation for a large community health system, and numerous roles in the human subjects protections arena. He holds a BSHS in Clinical Research Administration from the George Washington University and CIP, CRCC, and CHRC credentials.

During this presentation, you will learn:

  • Recount the purpose and regulatory foundation for reporting research results
  • Analyze the impact and implications of sharing research results on the clinical trial process and stakeholders
  • Devise practical and effective ways to incorporate the sharing of research results in the clinical trial life cycle

1 CRS credit hour

Click here to register via Training Tracker


Association for Clinical Research Professionals

“Sponsor Best Practices From a Study Coordinator Perspective: Changes Sponsors Should Make Today”
Date: Tuesday, June 13, 2017
Time: 11:00 AM – 12:00 PM
Location: College of Public Health G228

Overview

The Study Coordinator rarely has the opportunity to provide any type of feedback to study sponsors and their input is not often requested during study design. Through focus groups and survey administration, original research was conducted to determine actionable changes for sponsors to make to reshape clinical trial management with Study Coordinators in mind. Data will be presented as a case study to review research findings, the operational changes made based on findings and the tools used to facilitate changes. Tools and templates will be shared to support organizational changes, including: phone scripts, milestone surveys, mini protocols, and study checklists. Attendees will be armed with the knowledge needed to take the best practices back to their own organizations and assess the opportunity to implement change.

Speaker, Kristen Perkins, MS, CCRP, is a Clinical Research Associate within Trial Management at TESARO, an oncology-focused biopharmaceutical company within the Greater Boston area. Kristen has nearly 10 years of global clinical operations experience in multi-center Phase II-IV trials within a variety of therapeutic areas. Prior to joining TESARO, Kristen worked as a Site Manager, Clinical Trial Associate, Clinical Research Coordinator and Research Assistant. Her experience at top academic medical centers and a leading global CRO ignited her interest in project and site management.

During this presentation, you will learn:

  • Explain sponsor best practices for designing clinical trials with study coordinators in mind
  • Apply recommendations to clinical trial operations activities
  • Analyze opportunities for improvements at individual organizations

1 CRS credit hour

Click here to register via Training Tracker