Duke Clinical Research Update

Wednesday, July 3, 2019
By Duke Office of Clinical Research (DOCR)
Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

Research Community News
iRIS/OnCore Updates
DOCR News
Did You Know?
Training Opportunities
Clinical Research Employee Highlights
Partner Resources


iRIS/OnCore Office Hours

July 15 | 11 am | DMP 2W91
July 29 | 11 am | DMP 2W91
August 12 | 11 am | DMP 2W91
August 26 | 11 am | DMP 2W91

REDCap Office Hours

Tuesdays | 10 am | DUMC Library 212C Seeley G. Mudd Bldg
Thursdays | 2 pm | via WebEx
Fridays | 10 am | Erwin Square Room 1022


Research Community News

 

Duke’s Sweeping Overhaul of Clinical Research is Paying Off

This article originally ran June 10, 2019 and is courtesy of CTSI: https://ctsi.duke.edu/news/dukes-sweeping-overhaul-clinical-research-paying

When Sara Battles took a job in a clinical research unit at Duke three years ago, she didn’t know that a massive experiment in remaking clinical research operations was beginning.

But having been in the field for eight years already, she did know that evolution was overdue.

“The clinical research world is changing,” she says. “When I started, you got thrown into whatever position was available and learned on the job.”

Cameron Howes, an Assistant Research Practice Manager, has spent her entire 12 year career at Duke, first in Orthopaedics and now in Psychiatry. For most of that time, being clinical research staff meant that her workload was “based completely on what Principal Investigators asked for and what funding they had.”

Battles and Howes are two of more than 800 clinical research professionals at Duke. For years, their career paths have traveled an irregular, sometimes even chaotic landscape of inventive job titles and blurrily-defined roles.

But now, that landscape has completely changed.

Clinical research itself has changed a lot in the last twenty years—with evolutions in technology, regulations, and methods making the field more complex than ever. Naturally, this meant that the demands on the clinical research workforce changed, and people have been asked to take on increasingly diverse and sophisticated tasks.

Clinical research operations as a profession had not kept pace with these changes. As new responsibilities emerged—recruiting research participants through social media, for example—existing jobs had to be re-shaped on the fly.

“You could be asked to do things you didn’t have the position for,” says Howes. “There was a lot of variance in what one person was being asked to do and what another person at the same level was being asked to do.”

The result was a work environment at large medical research institutions like Duke that was frustrating, unfair, and inefficient in the eyes of workers and leadership alike.

Four years ago, Duke set out to solve this problem through a sweeping modernization of the clinical research landscape. Now, that effort has been fully implemented and is bearing fruit. Employees have consistent job classifications and responsibilities, as well as a clear path to advancement. The university is projected to save millions in costs through the ability to retain outstanding employees and operate more efficiently.

“Duke is now at the forefront of innovation not just in research itself, but in the way our research workforce is organized. This has created systemic efficiencies that improve the quality of clinical research,” says Mary Klotman, MD, Dean of the Duke University School of Medicine.

“The clinical research profession has been standardized across the institution,” adds Denise Snyder, Associate Dean for Clinical Research in the Duke School of Medicine. “This reduces organizational turbulence and creates opportunities for staff to grow their careers in a transparent, competency-based system.”

Building a ladder

This transformation was the result of a wide-ranging project initiated by Duke staff and made possible by collaboration with Human Resources, the support of faculty and leadership, and funding from Duke’s NIH Clinical and Translational Science Award.

It was a unique, grassroots effort in which a task force made up of staff with expertise in clinical research formed to study the problem and recommend a solution. They ultimately devised a career ladder that allows clinical research professionals to get training and demonstrate their competency in a variety of areas. They accrue points through a variety of activities, and when they accumulate enough points, they become eligible for promotion to a higher tier.

In stark contrast with the previous environment, where there were more than 80 job titles, there are now only 12 distinct job titles among the clinical research staff.

“The partnership with Human Resources was critical to our success,” says Ebony Boulware, MD, PhD, Director of the Duke Clinical and Translation Science Institute. “Today, HR managers have completely bought in and see the benefits in their own workload. We hope this leads to higher quality research and improved access to clinical research studies.”

For the employees, it has created clarity.

“I didn’t even know what level I was when I started the advancement process,” says Battles. “It helps me know where I stand professionally. I’ve had a lot more opportunities to be visible in the department, and it gives you the tools to advocate for yourself.”

Howes adds, “It was really rewarding to go out for these assessments and realize, ‘Hey, I do have these qualifications.’ It was affirming.”

Changing the landscape nationwide

The ripples of this innovation are spreading far beyond Duke’s walls. Nearly every large medical research institution faces similar problems—a confusing environment that leads to high staff turnover and job-hopping based on department funds.

“Staff turnover and training new employees is one of the largest expenses in clinical research,” says Snyder. “It costs around $25,000 per employee.”

Unsurprisingly, Duke’s new model is attracting interest nationwide. It is already being implemented at Johns Hopkins University and the University of Alabama, Birmingham, and more than a dozen other institutions have reached out to learn more.

Duke has received national recognition for its work, including the Innovation in Workforce Development Award from the Association of Clinical Research Professionals and the Rod Rose Award from the Journal of Research Administration.

The goal remains creating a finely-tuned clinical research infrastructure to support investigators.

“Researchers come to Duke in part because they know they will be supported by an outstanding clinical research team,” says Adrian Hernandez, MD, Vice Dean for Clinical Research at the Duke University School of Medicine. “This new framework is intended to raise the bar on the clinical research profession, and help people find ways to attain that bar.”

The team has published their framework in the Journal of Research Administration, and additional publications are underway.

 

Duke Research Community Needs Assessment Survey

The Duke CTSI has incorporated several new Cores to support Duke Researchers.  We're interested in your input on the proposed resources and services provided by these Cores.

The feedback and suggestions from faculty and research staff will help the Duke CTSA understand ways to enrich and improve services and programs to better serve and meet the needs of the research community.  This assessment takes less than 10 minutes to complete.

Click on the link below to open the assessment in your web browser:
Duke Research Community Needs Assessment Survey

If the link above does not work, try copying the link below into your web browser:

https://redcap.duke.edu/redcap/surveys/?s=PJYHL8DRCR

To learn more about the CTSA, visit this website: www.ctsi.duke.edu

 

Digital Health Day 2019

Save the Date: The Duke Mobile App Gateway is excited to announce Digital Health Day on September 25, 2019. This year’s theme for our one day conference is ‘Digital Health Across the Lifespan’. The program will include insights from experts in research, clinical care, and device development and will explore how health tech is used from pediatrics to gerontology.

Lunch will be provided.

We will be accepting abstracts for morning poster presentations starting in August 2019. Watch for announcements on Twitter and via our newsletter!

For additional information, please contact Leatrice Martin.

Sponsored by the Duke Clinical & Translational Science Institute

 

Save the Date:  Clinical Research Appreciation for Faculty and Staff

Save the date for Clinical Research Appreciation for Faculty and Staff Thursday, October 10, 2019 from 11 am until 1 pmThe annual Clinical Research Appreciation Event for Faculty and Staff is scheduled to take place Thursday, October 10th from 11:00 AM – 1:00 PM in the Trent Semans Center Great Hall and Atrium.  This drop in event is a celebration of the great work taking place in Clinical Research at Duke.  Mark your calendars now and stay tuned for additional details as the event approaches

 

Clinical Research Training Program Accepting Applications

The Clinical Research Training Program (CRTP) of the Duke University School of Medicine / Biostatistics and Bioinformatics Department provides academic training in the quantitative and methodological principles of clinical research.  CRTP is designed primarily for faculty, fellows, and other health professionals.  The program offers formal courses in research design, research management, medical genetics, comparative effectiveness, translational methodologies, and statistical analysis.

A degree option in the program leads to a Master of Health Sciences in Clinical Research, a professional degree awarded by the School of Medicine.  An advanced degree in a clinical health science (or two years of medical school) from an accredited institution is a prerequisite for admission either as a degree candidate or as a non-degree participant.  In addition, CRTP offers non-degree and certificate options for individuals interested in taking one or more courses.

The program is now accepting applications for the academic year 2019-2020. 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.mc.duke.edu. The application deadline for priority review was May 15, 2019. Applications will be accepted through August 1, 2019. On-line registration for fall term courses begin on July 8, and classes begin on August 26.

 

Request for Proposals: Translating Duke Health Neurosciences Initiative

Duke Health is excited to announce three pilot funding opportunities to build infrastructure and pilot data in support of an upcoming institutional application to become an Alzheimer’s Disease Center.  An overview of the three RFPs can be found below; visit www.translatingdukehealth.org for more information and specifics about each application.

  • Brain Bank Pilot Grants
    Seeking projects that use the Duke Brain Bank and Biorepository, up to two one-year awards each with a total budget of up to $75,000
  • Brain Imaging Pilot Grants
    Seeking projects that enhance Duke’s capabilities in the area of brain imaging for research in Alzheimer’s Disease, up to two one year awards each with a total budget of $75,000
  • Pilot Project Grants in Alzheimer’s Disease Research
    Up to four one-year awards, each with a total budget of up to $50,000, with particular interest in projects that generate pilot data and show Duke’s strength in areas such as biobanking, special populations, model organisms, -omics, or data science

These are three separate RFPs, and applicants should clearly identify which opportunity they are applying for. Investigators are permitted to apply for more than one RFP. All applications are due August 2.  Completed applications should be submitted as one combined Adobe Acrobat file (PDF) to translatingdukehealth@duke.edu.  Questions may also be directed to the same email address. 

 

CTSI Funding Opportunities Announced

CTSI Translational Accelerator Funding Agreements (Deadline: September 5, 2019)

  • Up to $150,000
  • Purpose: Support for cross-disciplinary scientific research addressing the development of therapies diagnostics, or devices applicable to human disease, clinical research trials (excluding Phase 2 and beyond), epidemiological studies, and/or community-based research.
  • More information and application details

 

CTSI Transformative Funding Agreements (Deadline: September 5, 2019)

  • Up to $500,000
  • Purpose: Supporting the development of mature research with the potential to attract significant interest for external partnering, thus enabling and accelerating translation of research out of the academic environment.
  • More information and application details

iRIS/OnCore Updates

 

iRIS/OnCore Office Hours Available

The Duke Office of Clinical Research hosts iRIS/OnCore Office Hours twice per month. Instructors are available to assist end users with general questions regarding using the iRIS system to submit protocols to the DUHS IRB and use of the OnCore System. Please bring a laptop if possible along with your protocol specific questions to the sessions.

Dates and locations for July and August are:

  • July 15, 11 AM – Noon, DMP 2W91
  • July 29, 11 AM – Noon, DMP 2W91
  • August 12, 11 AM – Noon, DMP 2W91
  • August 26, 11 AM – Noon, DMP 2W91

 

OnCore: Summary Accrual

Summary Accrual allows you to record the number of participants without having to individually register each participant.  Whether or not the Summary Accrual feature can be used depends on the status of the study at go live (5/21/2018), the type of study, and if participants are from a Duke patient population or the community.

Two new tip sheets are available for determining if Summary Accrual is an option for your study and provide instructions for entering the accrual:

Use of Summary Accrual is optional. If you are interested in using Summary Accrual, use the tip sheets to determine if your study qualifies. Approval of individual studies is not required unless a study does not meet the criteria listed.

It is important to note that the format for Summary Accrual in OnCore is different from what the IRB uses at annual renewal. 

In OnCore, the gender + race + ethnicity make up one category.  For example, participants who are White, female and Hispanic are one category.  White, female and non-Hispanic participants are a separate category.

The number of participants accrued in a category are entered for each time period.  For new studies, monthly entry is preferred but up to quarterly entry is allowed.

A spreadsheet is available on the OnCore support page to help organize your data prior to entry.

For questions please contact DOCR.help@dm.duke.edu


DOCR News

 

Maestro Care:  Updates to the Inpatient Encounters with Staff Members Assigned to the Inpatient Treatment Team

To assist users to choose the correct providers while placing orders, the Treatment Team Filter will be defaulted. If you are entering a verbal order given by someone not on the treatment team, you may need to unselect the Treatment team filter, but you will need to take extra care to be sure you choose the correct providers, so review the address and other information on the provider selection window if you must uncheck the filter.

 

Tier Advancement Overview Course Now Available

The online Tier Advancement Overview now available in the Duke Learning Management System provides an overview of the Tier Advancement process and tips on how to navigate the Duke Office of Clinical Research Workforce Engagement and Resilience (WE-R) web page to access important tools and resources available.

Register for Tier Advancement Overview Course

 

Placing Informed Consent Forms and Consent Process Notes in Maestro Care Policy Now Available

A new policy Placing Informed Consent Forms and Consent Process Notes in Maestro Care is now available on the DOCR website.  This policy outlines when placement of the informed consent form and consent process note are required in Maestro Care.

 

Research Professionals Network:  Write Like an 8th Grader:  Improving Readability in Clinical Research

Thursday July 25, 2019 at 1:00PM in Trent Semans Great Hall

Write Like an 8th Grader: Improving Readability in Clinical Research

How do you ensure that your clinical research materials are readable for the audience that you want to reach?

This presentation will help you learn how to measure and improve the readability of your clinical research communications to participant and public-facing audiences. We will discuss the importance of readability and explore the pros and cons of available resources. Examples from the Duke Clinical Research Institute (including informed consent forms, recruitment materials, and lay summaries) will be used to highlight existing and free resources that may be used to improve your communications.

Light refreshments will be provided. Please use this link to register

Learn more about the Research Professionals Network


Did You Know?

 

REDCap: Fields and Load Time

Adding too many fields on a form can slow down a form when loading.  It is recommended to limit the number of variables to less than 500 variables on one form, preferably less.  Consider splitting up the data collection into separate forms. If your forms are designated as surveys, you can enable the option to Auto-continue to next survey.  This can be found under the survey settings.

Please contact redcap-docr@duke.edu with any questions.


Training Opportunities

 

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

Detailed information about each offering and direct links to the offering are also available on the DOCR Course Listing.


Clinical Research Employee Highlights

 

  • The Office of Research Contracts is happy to welcome Rita Morrison to the staff of the Site Based Research group.  Rita is an alumnus of NC State University, and received a JD from NC Central University. Rita joins ORC with experience in site contract negotiations at DCRI.  Welcome Rita!
  • Duke University School of Nursing is excited to welcome Alex Gualtieri to the Sickle Cell Disease Implementation Consortium (SCDIC) research team.  Gualtieri joined DUSON in May as a clinical research coordinator for Dr. Paula Tanabe’s SCDIC study.  Prior to joining DUSON, she worked at Duke Clinical Neuropsychology Service for the past four years as a neuropsychological technician and a research coordinator.  Gualtieri graduated from the University of North Carolina at Chapel Hill with a Bachelor of Science degree in environmental science.  She resides in Rutherford.  Please join us in welcoming Alex Gualtieri to DUSON!
  • Department of Medicine welcomes the following new staff:
    • Justin Magin – CRS, Sr. in Pulmonary
    • Allison Johnson- CRC in CAGPM
    • Shuqin Li- CRNC in ID
    • Annmarie Sommerville- CRNC in Geriatrics
    • Lauren Hale - CRS, Sr. in ID

Partner Resources

 

DUHS Compliance Office Newsletter

Catch up on news from the DUHS Compliance Quarterly Newsletter.

Subscribe to the Clinical and Translational Science Institute (CTSI) Bi-Weekly Newsletter

Stay up to date on news, funding, and education opportunities in translational science at Duke by subscribing to CTSI UPDATES. Read past newsletters and subscribe at https://www.ctsi.duke.edu/news/newsletters.

 

To be added or removed from the distribution list for the Duke Clinical Research Update, please contact DOCR at docr.help@dm.duke.edu.