Q&A with Wright Center ClinicalTrials.gov Program Administrator, Alanda Perry Jones

Q&A with ClinicalTrial.gov Program Admininstator, 
Alanda Perry Jones, MA, CCRP
 
During recent workshops, she reviewed a summary of the 2017-2018 changes, delved into case studies to better understand NIH’s expanded interpretation of the definition of a clinical trial, and provided resources for researchers to use as they develop their proposals.
What are the takeaways you want from these workshops?
 
The main takeaways are these: NIH has implemented many policy changes over the past year to improve transparency and accountability in human subject research, especially clinical trials. NIH uses a broad interpretation of the definition of a clinical trial. This includes certain mechanistic studies, which are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.
What are the major changes?
  1. The funding opportunity announcement (FOAs) will specify whether clinical trials are required, optional, or not allowed.
  2. NIH has revised their proposal form to consolidate and streamline human subjects information. Investigators must use the new Form E.
  3. Multi-site studies must use a single IRB.
What are some of the questions you are getting?
Many investigators are asking whether their particular study qualifies as a clinical trial. Research administrators at VCU can provide guidance on this, but with so many changes occurring at once, the best source of truth is the NIH program officer.
What is your role at the Wright Center for changes like these?
My specific role is ensuring that VCU is compliant with ClinicalTrials.gov regulations, which require outreach and education, as well as input from the research community. The influence of ClinicalTrials.gov over research will likely continue to grow as long as transparency and accountability remain a priority. My goal is to make sure that we’re meeting our important reporting obligations in a way that is as painless as possible.
If you need additional information please visit the National Institute of Health website at:  grants.nih.gov/policy/clinical-trials.htm or contact Alanda Perry Jones at: perryar@vcu.edu

Research Expo 2017

Come to the Research Expo and find out how the Wright Center for Clinical and Translational Research can help you!  The sessions are divided into two tracks that will run concurrently.  The Wright Center’s Lydia Klinger and Tim Aro will be presenting the following sessions that day.  Come and check it out!

Session Title: First Look: Wright Center Clinical Research Coordinator Education & Training Program 

Presenters: Meghan Wright – IRB Training & Education Manager; Lydia Klinger –Director of Business Operations, Wright Center for Clinical and Translational Research

Lydia Klinger, Director of Business Operations-Wright CCTR

 

 “I’m excited the Wright Center is taking such a central role in establishing programs that will promote the role of clinical research coordinators, both by providing them with standardized and robust training opportunities, and by being an advocate for their professional development and recognition.” 

Session Description: While clinical research coordinators at VCU share many of the same responsibilities, training and education has historically varied from department to department. This session offers you a first look at the Wright Center’s CRC Education & Training Program, a collaborative initiative designed to provide a comprehensive, standardized approach to support quality clinical research at VCU. With robust resources, multiple training mechanisms, and tools to support clinical research coordinators and their supervisors, this program is designed to meet everyone’s needs. Come get a sneak peek at what the CRC Taskforce has up its sleeve for 2018!

Contact Info: Meghan Wright-wrightmk2@vcu.edu, (804)-828-4996, Lydia Klinger-lydia.klinger@vcuhealth.org, (804)-628-0245

Session Title: Informatics Tools and Services Supporting the Clinical Research Life Cycle

Presenters: Tim Aro, Manager – Clinical Research Informatics; Bobby Moulden, Manager – OnCore Clinical Trial Management 

Tim Aro, Manager Informatics-Wright CCTR

“Our goal is to provide the tools and services to allow investigators to focus on the science.  Let the Wright Center help you with the technical aspects so scientists can focus on their research and bring new treatments to patients.”

Session Description: The Wright Center for Clinical and Translational Research will present a variety of informatics tools and services and describe how they can help support the clinical research life cycle.  This pragmatic presentation will discuss technologies that can be leveraged during various phases of the clinical trial life cycle.  Find out how informatics resources can help with study design/feasibility, multi-site collaborations, work flows, recruitment and trial management, electronic data capture solutions, and more.

Contact Info:  Tim Aro- timaro@vcu.edu, 804-628-4795 and Bobby Moulden- rbmoulden@vcu.edu, 804-628-1991