Duke Clinical Research Update January 20, 2021

Wednesday, January 20, 2021
This image is the Duke Clinical Research Update Banner

 

 

 

 

 

 

 

 

 

SUPPORT OFFICE HOURS

REDCap Office Hours

 

Email redcap-docr@duke.edu to schedule a virtual session at one of the times indicated below.

Tuesdays 10 AM, virtual sessions
Wednesdays 10 AM, virtual sessions

Thursdays 2 PM, virtual sessions

Fridays 10 AM, virtual sessions

 

SlicerDicer Office Hours

Thursdays, 2 PM, via WebEx

Click for SlicerDicer Tipsheets

 

PACE Office Hours

Every other Tuesday, 1 PM, via WebEx.  Click for information.

 

RESEARCH COMMUNITY NEWS

 

COMING SOON – Survey of the Duke Research Climate 2021!

In mid-February, all research faculty, staff, postdocs, and graduate/medical students campus-wide will receive an email request to participate in the Duke University Survey of Organizational Research Climate (SOURCE).  

The survey was developed and validated by the National Center for Professional and Research Ethics (NCPRE) at the University of Illinois at Urbana-Champaign and NCPRE will conduct the survey on behalf of Duke. 

The survey results will provide an assessment of Duke University’s climate for scholarly and research integrity, and will be used to evaluate and develop policies or target interventions to make this a better place to conduct research and other scholarly work.

The email request will provide a link so you can complete the anonymous survey online, and it will take about 15 minutes of your time.  The survey is anonymous, and survey responses will be linked only to the participants’ unit; only aggregated response information will be collected and reviewed.

The more participation we have, the better the survey data will be!  We hope all researchers will consider participation to help us improve the research climate at Duke.  If you have any questions about the survey, please feel free to contact the project coordinator, Donna Kessler, PhD, at 919-668-5115.

 

Clinical Research Training Program (CTRP) is accepting applications for Academic Year 2021-2022

The program is now accepting applications for academic year 2021-2022. For a detailed description of the program, the course offerings, and a link to the online application, please visit the CRTP website at http://crtp.duke.edu.

 

CRTP trains clinical researchers in leading-edge investigative practices grounded in sound scientific principles promoting reproducible research and rigorous ethics training and practice.

 

Last year, CRTP launched the Basic Science Research Track (BSRT), a customized curriculum designed for physician scientists and trainees across a range of discovery sciences. The curriculum includes new coursework that prepare researchers to: perform rigorous basic science; manage, analyze, and present data; oversee a laboratory; and successfully compete for research funding.

 

As one of the oldest clinical research training programs in the nation, we are committed to producing the next generation of leaders shaping clinical research today and building on Duke’s pioneering role in biomedical research.

 

The application deadline for priority review is April 15, 2021. Applications will be accepted through August 1, 2021.

 

COVID-19 Research Open House Week

January 19th - 25th, 2021

N3C is hosting an Open House to engage CTSA members, newcomers, and the wider translational research community. The event will be kicked off with a 1-hour symposium, followed by a week of open Clinical Domain Team meetings to welcome new collaborators and help them launch their research questions.

Participating Meeting Schedule:  email data2health@gmail.com for invites to Domain Team meetings of interest.

Event schedule

Reach Equity Funding Opportunities

Reach Equity logo

Awards supporting investigators at every career stage who are interested in conducting research that aims to reduce racial and ethnic health disparities and promote health equity. There are three funding opportunities:

 

  • Research Vouchers Program: supplements currently funded research, or supports standalone research projects conducted by faculty at any level, broadly related to the REACH Equity theme, and completed over one year. Funding: One year up to $12,500 per award.
    • Full Research Vouchers Program RFA and application instructions are available here
    • Current awardee list is available here

 

  • Research Scholars Development Program: supports early-stage investigators (residents, fellows, postdoctoral students, nursing trainees with a research or health professional degree or equivalent trainees) who are interested in conducting health disparities research.  Scholars work with a faculty mentor (identified by the trainee) to develop a research proposal and complete a project over one or two years. Funding: Up to $5,000 total for one or two year project per award.
    • Full Research Scholars Development RFA and application instructions are available here
    • Current awardee list is available here

 

  • Transdisciplinary Think Tank (TTT): supports faculty brought together across disciplines who have a common interest in addressing racial and ethnic disparities in the clinical encounter.  The TTTs aim to catalyze and support research related to the REACH Equity theme and to foster collaboration among health disparities researchers across Duke University. Funding: One year up to $1,500 per award.
    • Full Transdisciplinary Think Tank RFA and application instructions are available here
    • Current awardee list is available here

 

Applicants for all three awards should propose research broadly related to the Center theme.  Proposals may include any research method (quantitative, qualitative, etc.) idea, but should clearly focus on issues related to addressing racial and ethnic disparities or improving underrepresented racial and ethnic populations health in the clinical setting. 

 

Application submission deadline: March 15 for July 2021 funding.

 

Contact Cheryl Miller with questions: Cheryl.j.miller@duke.edu

 

 

DOCR NEWS

 

Research Professionals Network:  Part 2- Diversity in Clinical Research: What We Have Learned

Thursday January 21, 2021 at 1:00 on Zoom

 

Clinical research generates new evidence (or validates old evidence) about the efficacy and safety of new therapies. However, how groups of the population respond to a new therapy may vary; men may respond differently than women, older people may respond differently than younger people, and members of a certain racial or ethnic group may respond differently than another. Identifying these differences makes it imperative that we enroll diverse groups of participants into our research studies to ensure that the results are representative of the people who will make use of the therapy or treatment, thereby improving outcomes and, hopefully, reducing disparities. Unfortunately, racial and ethnic minorities have been historically underrepresented in research, creating scientific, ethical/moral, and medical issues by biasing results that are also not generalizable to the broader population.

 

More recently, the COVID pandemic has been real wake-up call for all of us, demonstrating how important it is that we reach out and engage minority populations in meaningful research so that we can ensure that the treatments and vaccines we develop are as appropriate for them as they are for others.

 

People come from all walks of life and each walk presents its own barriers to opportunity. It is not enough that opportunity exists; we must ensure that there is a clear path to accessing that opportunity, whether through the provision of additional time, effort, or resources. As researchers and research staff, we cannot simply seek answers. We must also seek to remove barriers that prohibit us from answering those questions in populations that often need us the most and are yet underrepresented in our studies. – Nicole Daniels, CRS, Sr.

 

We have assembled a panel of study staff and investigators who will share their experiences engaging and enrolling underserved and underrepresented populations in their research projects. The panel will provide insight and ideas, from engaging at the level of selecting a question and designing a study to answer it, all the way through planning the dissemination of study results.

 

Speakers:  Nadine Barrett and Keisha Bentley-Edwards

Join Zoom Meeting
https://duke.zoom.us/j/96388400430

 

Learn more about the Research Professionals Network at docr.som.duke.edu

 

Policy Update:  Institutional Approval: New Clinical Research Study Initiation, Review, and Approval Standards

The Institutional Approval: New Clinical Research Study Initiation, Review, and Approval Standards policy has been revised to update the various workflows needed prior to Institutional Approval being granted and to specify that IRB exempt, HUD/HDEs, Trainee Applications, and expanded access protocols do not require Institutional Approval. 

 

Full text of this policy can be found here and is posted to the DOCR website in the DOCR Policies and Procedures in the Study Start Up section.

 

 

RECRUITMENT INNOVATION CORNER

Clinical Trials Directory and COVID-19 Research Website

Clinical Trials directory logo

Just a reminder……

As research studies continue to re-open, please remember to make sure your study is listed on the Duke Clinical Trials Directory. 

 

Something NEW….

The RIC has been working with the COVID-19 Research Task Force to get many of our COVID-19 studies and trials on the Directory and to create a new COVID-19 Research website!  Check it out here or type www.dukeCOVIDstudies.org into your browser.   This website includes inpatient and outpatient trials, repositories, registries, and condition specific studies.  We are also providing Spanish translations for any COVID-19 studies on the directory that wish to have a translation.

Graph Section Visits per Week

 

We have seen a significant increase in visitors to the Clinical Research Information pages and the Clinical Trials Directory since COVID-19 happened –some days with over 800 visits!

 

We are now allowing select studies to post on the Directory even if they are not actively enrolling.  If your study status is paused (e.g., suspended or on hold) or abandoned but you still want it pushed onto the directory Contact the RIC. We will review these requests on a case-by-case basis.

Graphic text Now Available

If your study is Open to Accrual, On Hold, Institutional Approval Sign-Off, Suspended, or Abandoned we can manually push it to the directory.  If it is listed as New, PRMC Approval (Oncology only), IRB Approval, SOMF Approval, or Closed to Accrual, we unfortunately cannot push it onto the Directory.

 

If you have a study that is actively enrolling and it is not listed but you would like it to be, please don’t hesitate to reach out to the Recruitment Innovation Center!  We can be reached at studyrecruitment@dm.duke.edu or at 919-681-5698.

Text graphic Contact Us

As always, please Contact us for any of your research needs!  We can help you develop engaging eConsents, MyChart messages, websites, engagement letters, research notices, and more!

 

Follow us on Facebook at Discover Duke Research.

 

 

 

 

 

TRAINING OPPORTUNITIES

Financial Basics Course Now Available in Online Format

The Financial Basics Course has transitioned to an online format and is now available in the Duke Learning Management System (LMS).

 

Runtime: 30 minutes

This course is designed to help participants understand the financial concepts associated with the life cycle of a clinical trial/research study.

 

Learning Objectives - Upon completion of this module, you will be able to:

  • Describe clinical research from a financial perspective
  • Describe the types of costs associated with a clinical trial/research study
  • Describe the concept of effort management
  • Describe financial and management reporting
  • Describe financial close-out requirements
  • Describe systems useful in following financial activities associated with a clinical trial/research study

 

Register for Course

 

Upcoming DOCR Training Offerings

DOCR training offerings are available in the Duke LMS. There are 2 easy ways to find all DOCR classes: Enter “DOCR” in the search field and click Search, or click the Category link, and then click the DOCR link. The results display all the offerings currently available from DOCR. Hint: If you want to bookmark the Duke LMS in your browser, edit the bookmark to this address:

 

https://lms.duhs.duke.edu/Saba/Web/Cloud

 

Upcoming training offerings can be viewed by month on the DOCR Calendar.

 

Detailed information about each offering and direct links to the offering are also available on the DOCR website under Available DOCR Trainings.

 

 

CLINICAL RESEARCH EMPLOYEE HIGHLIGHTS

The Department of Medicine CRU announces the following:

  • Deroya Minor-Alston, CRC joined Nephrology 12/07/2020
  • Vivek Pisharody, CRC, Sr. joined CTSI - GIM 12/21/2020
  • Rebecca Mangus, CRC joined ID 01/04/2021
  • Marina Pieretti, CRC joined CAGPM 01/04/2021
  • Elizabeth Earnhardt, CRS, Sr. joined CTSI - GIM 01/04/2021
  • Alyssa McGowan, CRC joined ID 01/11/2021
  • Caroline Questell, CRNC will join ID 02/01/2021

 

The Department of Radiology CRU announces the following:

  • Welcome to New CRU Team Members:
    • Mona Malik – CRC
    • Donna Silva - CRC   
  • Congratulations to LaTonia Strader, promoted to CRC

 

 

PARTNER RESOURCES

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Catch up on news from the DUHS Compliance Office.

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