Cite the Grant!

Please remember to acknowledge NIH grant support in each publication, press release or other documents about research that benefited from the many resources made possible by the VCU Wright Center for Clinical and Translation Research (CCTR)’s Clinical and Translational Science Award (No. UL1TR002649 or KL2TR002648) and include a disclaimer.

Learn about PubMed requirements and how to cite at https://cctr.vcu.edu/resources/cite.html

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

Check out these events!

Monday, November 13th- 12 PM- 1 PM, Main Hospital, Learning Center

Please join us for the Wright Center for Clinical and Translational Research’s Discovery Dialogues seminar, “Discovering ways to make cost-effective medicines: A case study with ciprofloxacin”, presented by Dr. Perrer Tosso, Post-doctoral Fellow, Chemical and Life Science Engineering, on Monday, November 13 from noon – 1PM in the hospital’s Learning Center (Main Hospital, first floor, across from the cafeteria).

Faculty, staff, students, patients, and families are invited to attend. Light refreshments will be served. For more information, contact Pam Dillon at pmdillon@vcu.edu.

Tuesday, November 14th- 9 AM- 12 PM, BioTech One

Learn how to communicate your research!

Scientists are increasingly called to share their research outside of traditional academic spheres. Engagement with non-academic audiences can help increase the public’s science literacy and shape impactful policy decisions. How can we share science in a way that both engages non-experts and accurately presents complex topics? To register, click here: http://vcu.libcal.com/event/3676022.

This event is sponsored by: VCU Center for Clinical and Translational Research, VCU Libraries, and Office of Research.

9 – 9:50 a.m. “Teaching journalism to scientists — and science to journalists,” Dr. Jeff South, VCU Robertson School of Media and Culture

10:00 – 10:50 a.m. Perspectives in Publishing: A Panel Presentation

11 a.m. – 12:30 p.m. Keynote Presentation: “Be Such a Scientist: Improving How We Communicate and Connect with Public Audiences,” Holly L. Menninger, PhD. Director of Public Science, College of Sciences, NC State University

Wednesday, November 29th-12 PM-1 PM

The Wright Center for Clinical and Translational Research and Tompkins-McCaw Library present the next in their lunch research seminars, “NIH Clinical Trials 2018: New Definition, New Policies,” on Wednesday, November 29, from noon – 1PM in the Tompkins-McCaw Library, Room 109.

Ms. Alanda Perry Jones, CCTR, will discuss changes to human subjects’ research for the January/February funding cycle. During this session, she will review a summary of the 2017-2018 changes, delve into case studies to better understand NIH’s expanded interpretation of the definition of a clinical trial, and provide resources for researchers to use as they develop their proposals.

Participants may bring lunch, drinks will be provided. For more information or to register, contact Pam Dillon (pmdillon@vcu.edu).

 

 

Changing policies impact NIH-funded studies!

 

The NIH announces numerous policy changes to improve the stewardship of clinical trials.

Please read the full announcement here:


Message to NIH grant applicants/awardees, contractors, researchers and research administrators:

If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you:

  • select the right NIH funding opportunity announcement
  • write the research strategy and human subjects sections of your application
  • comply with appropriate policies and regulations

First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form.

For application due dates of January 25, 2018, and beyond, you will be required to use an updated application forms package (FORMS-E), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here.

Second, take a moment to answer these four questions about your current or proposed research:

1) Does the study involve human participants?

2) Are the participants prospectively assigned to an intervention?

3) Is the study designed to evaluate the effect of the intervention on the participants?

4) Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency.

Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure?  Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.

Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials.

NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including:

  • the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning January 25, 2018.
  • Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.
  • updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after January 25, 2018.
  • new Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-E) for due dates on/after January 25, 2018, and contract solicitations published as of January 25, 2018.
  • use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
  • expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.

Improving the design, efficiency, and transparency of clinical trials is important because it:

  • respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate
  • facilitates design of clinical trials while reducing unnecessary duplication
  • promotes broad, timely, and responsible dissemination of research information and results
  • fosters responsible stewardship of the public’s investment in biomedical research

We have developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know.  Please review this information carefully.  Your attention to detail will be critical to ensuring successful funding of your clinical trial awards.

We will be putting out a series of reminder policy notices, training opportunities, and other resources in the NIH Guide to Grants and Contracts, in the NIH Extramural Nexus, and on my blog.

The success of clinical trials relies on the public trust in scientific rigor and ethical oversight.  We all play a critical role in this process.  We are most grateful to you for your help and support.

Best,

Michael S. Lauer, MD

Deputy Director for Extramural Research, NIH

One Center Drive, Building 1, Room 144

Bethesda, MD 20892

 

CCTR Hosts Final Fall Brown Bag Seminar Featuring OnCore Discussion

11x16 Brandbar Header

The VCU C. Kenneth and Dianne Wright Center for Clinical and Translational Research hosted its fifth and final seminar as part of an ongoing Fall Brown Bag series where representatives from the VCU Wright CCTR raised awareness of the various tools and services offered by the Center. 

Robert “Bobby” Moulden, manager of Clinical Trials Management System for the VCU Wright CCTR, led this presentation with a particular focus on Online Collaborative Research Environment (OnCore), which is a Clinical Trials Management System (CTMS) designed specifically for large academic medical centers with vibrant, expanding clinical research programs. The event received a large turnout with representatives from the VCU Department of Pathology, VCU Massey Cancer Center, VCU Department of Neurosurgery, and the VCU Department of Internal Medicine, among others in attendance. 

OnCore is a web-accessible, centralized database with role-based security. It provides a platform to track clinical research studies and participants, and includes features such as  audit/monitoring capabilities, electronic case report forms (eCRFs), and custom reporting. Additionally, patient research participation is now shared from OnCore to Cerner through an integration.

Moulden and his team reviewed OnCore’s audit console, which supports a standard institutional audit process and incorporates input provided by the VCU Office of Research and Innovation’s Clinical Research Compliance Program, the Institutional Review Board, and VCU Massey Cancer Center.

“OnCore helps coordinators work together on the most up to date forms and information,” Moulden said. “It eliminates the need for teams to email files back and forth and provides a secure platform for materials containing patient health information.”

To learn more about OnCore, visit go.vcu.edu/oncore or go.vcu.edu/wiki. Email OnCore@vcu.edu with questions.

dsc_0916

dsc_0912

First image up top: Robert “Bobby” Moulden, manager of Clinical Trials Management System for the VCU Wright CCTR

Dr. Moeller Discusses Clinical Research with Visiting Italian Medical Students

11x16 Brandbar Header

The VCU C. Kenneth and Dianne Wright Center for Clinical and Translational Research proudly welcomed nine medical students from the Università Campus Bio-Medico in Roma, Italy to VCU for a two and a half week program titled, “A Primer on Clinical and Translational Research.”

The program took place from Monday, Sept. 5 to Saturday, Sept. 24, during which time the Italian students attended lectures on clinical and translational research with Antonio Abbate, M.D., Ph.D., medical director of the Wright CCTR’s Clinical Research Services, and associate chair of the VCU Scientific Review Committee, and other esteemed VCU scientists and researchers. 

The students also visited the Richmond Academy of Medicine (RAM) building to meet with F. Gerard Moeller, M.D., director of the VCU Wright CCTR, who sat down with the group to discuss the value of clinical research and the paths to a research career. 

“As a medical professional, there is always a pull to just do clinical work because the career path of a researcher is difficult,” Moeller said. “But the work done by researchers is a vital component of the scientific field and there are many funding opportunities, fellowships, and mentors available to support you along your path.”

Dr. Moeller also stressed the importance of young scientists finding a good team and supportive institution. He explained the functions and services of the various programs offered to researchers by the VCU Wright CCTR, including protected time in the form of the KL2 (formerly known as K12) scholar program. The KL2 provides substantial salary support and $25,000 in start-up funds for faculty-level clinical and translational scientists near the beginning of their investigative careers. 

The Italian medical students’ visit to VCU was made possible by a cooperative partnership between VCU and the Università Campus Bio-Medico. This past June, five American students in their 3rd and 4th years of VCU’s medical program visited Italy for three weeks as part of an intensive training program dedicated to generating enthusiasm for research and exposing VCU students to medical practices abroad. 

dsc_0432

dsc_0439

First image up top: F Gerard Moeller, M.D., director of the VCU Wright CCTR , presents a lecture on the value of clinical research

CCTR to Co-sponsor Workshop on the Art of the Engaged Lecture

11x16 Brandbar Header

What can scientists do in a limited time frame to nudge student thinking from passive to engaged? How can one do this without significantly adding to their existing workload? The VCU community now has the opportunity to learn about the science and art of crafting significant learning experiences for students through an upcoming workshop. 

lisa-phipps
Lisa Phipps, Ph.D., Pharm.D.

The C. Kenneth and Dianne Wright Center for Clinical and Translational Research and Tompkins-McCaw Library are co-sponsoring a brown bag lunch workshop that will walk participants through a variety of best teaching practices that can be contextualized and transferred to individual teaching methods.

enoch-hale
Enoch Hale, Ph.D.

Lisa Phipps, Ph.D., Pharm.D., online learning innovation specialist for the the VCU Academic Learning Transformation Lab, and Enoch Hale, Ph.D., director for the VCU Center for Teaching and Learning Excellence, will lead this free presentation on Monday, Oct. 3 from noon to 1:00 p.m. at the Tompkins-McCaw Library, Room 2-010 (second floor).

Please visit http://go.vcu.edu/_qip to register.  

 

 

VCU Involved in Adolescent Brain Cognitive Development (ABCD) Study – 10,000 Children to Participate

11x16 Brandbar Header
The VCU C. Kenneth and Dianne Wright Center for Clinical and Translational Research (Wright CCTR) and the VCU Institute for Drug and Alcohol Studies are proud to announce that Virginia Commonwealth University is slated to begin recruitment within the coming weeks for the Adolescent Brain Cognitive Development (ABCD) study, the largest long-term study of brain development and child health in the United States.

logo_abcd_1000x529The National Institutes of Health (NIH) will follow the biological and behavioral development of more than 10,000 children beginning at ages 9-10 through adolescence into early adulthood. Recruitment will be done over a two-year period through partnerships with public and private schools near research sites across the country as well as through twin registries.

“The ABCD project is the largest long-term study of brain development and cognition in the United States,” said F. Gerard Moeller, M.D., director of the VCU Wright CCTR and the VCU Institute for Drug and Alcohol Studies. “This is an important collaboration across institutes and centers within VCU and across the United States.

Virginia Commonwealth University is one of four sites out of the 19 total ABCD Consortium sites that will recruit pairs of twins. With the support of the VCU Office of Research and Innovation, the VCU Wright CCTR’s Mid-Atlantic Twin Registry will aim to recruit 200 pairs of twins from Virginia and other surrounding states.

“Incorporating twins into the ABCD study provides researchers with a unique ability to study ‘what-if’ questions,” said James M. Bjork, Ph.D., associate professor in the VCU Institute for Drug and Alcohol Studies, the VCU Department of Psychiatry, and the VCU Department of Pharmacology and Toxicology. “By testing twins that may differ on various experiences, researchers can more confidently link experiences in a child’s life to how his or her brain developed. This enables us to approximate that ‘what if’ scenario, and add additional scientific value to the ABCD Consortium.”

The ABCD longitudinal study will also utilize advances in imaging technology, which were recently installed in the Wright CCTR’s Collaborative Advanced Research Imaging (CARI) MRI scanner.  The CARI scanner employs cutting-edge “multiband” technology to stimulate multiple portions of the brain simultaneously and read out all of the data from those slices. This technology dramatically improves the sensitivity of MRI testing and enables VCU researchers to receive finer spatial resolution images or take more images over time than previously able.

Visit www.abcdstudy.org to learn more about the study.

Official NIH press release below [Download here]:

pr-abcdlaunch-final-to-ics-and-pios-1-1

pr-abcdlaunch-final-to-ics-and-pios-1-2

 

CCTR Doctoral Candidate Shares Experience at NIH’s Clinical Center Summer Course

11x16 Brandbar Header

The C. Kenneth and Dianne Wright Center for Clinical and Translational Research (Wright CCTR) at VCU held a CCTR Student Talk on Wednesday, September 7 in the Richmond Academy of Medicine’s conference room.

Elizabeth K. Do, MPH, a doctoral candidate in the Wright CCTR’s psychiatric, behavioral and statistical genetics concentration, presented on her two-week intensive program experience at the National Institutes of Health (NIH) in Bethesda, Md. She was one of 28 students nationwide accepted for a spot in the NIH’s competitive 2016 Clinical and Translational Research Course for Ph.D. Students that addressed the topic: “What is the role of the PhD scientist in clinical and translational research?”

The goals of the course were to:

  • Demonstrate potential roles of a Ph.D. scientist
  • Provide overview and examples of connections between basic science, clinical observations, and translational research
  • Increase awareness and access to Ph.D. role models, research resources, potential career opportunities

“One of the key takeaways I learned in this course is the importance of being persistent,” Do said. “The career of a translational researcher isn’t easy and sometimes your success will rely on your persistence in the pursuit of answers.”

Applications for the 2017 NIH Clinical and Translational Research Course for Ph.D. Students will be made available online from February 2017 until June 2017. 

If you are interested in learning more about educational programs within the Wright CCTR, please contact Risham Qureshi at qureshira@vcu.edu or call 804-628-5414.

DSC_0341

DSC_0348

First image up top: Elizabeth Do (left), CCTR-PBSG doctoral candidate, presents on her experience with the NIH Clinical Center Summer Course.

CCTR’s Fall Brown Bag Lunch Series Kicks Off Aug. 18

The VCU C. Kenneth and Dianne Wright Center for Clinical and Translational Research (Wright CCTR) will host the first of its new fall Brown Bag Lunch seminars on Thursday, Aug. 18.

Antonio Abbate, M.D., Ph.D., associate chair of the Scientific Review Committee (SRC), medical director for the CCTR’s Clinical Research Services Center, and vice-chairman of the Division of Cardiology for the VCU School of Medicine’s Department of Internal Medicine, will lead a presentation on the Scientific Review Committee, which was established to provide study design, analytic planning and operational feasibility peer review of clinical research before review by the IRB.

This presentation is the first in a series of five fall CCTR Brown Bag Lunch seminars taking place over the coming months. 

FLYERS (24)