Duke Clinical Research Update February 19 2020

Wednesday, February 19, 2020
Logo for Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

 

 

 

 

 

 

SUPPORT OFFICE HOURS

 

REDCap Office Hours

Tuesdays 10 AM, Medical Center Library 212C in Seeley G. Mudd
Thursdays 2 PM, via WebEx
Fridays 10 AM, Erwin Square Conference Room 1022

 

SlicerDicer Office Hours

Thursdays, 1 PM, Erwin Square 10th floor

 

PACE Office Hours

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

 

RESEARCH COMMUNITY NEWS

 

Duke IT Security Office Phishing Alert:  Beware Coronavirus Scams

As Duke continues to monitor the coronavirus outbreak, Duke’s IT security offices are warning staff, faculty and students to beware malicious emails claiming to be from health organizations including the CDC.

 

Attackers are using fear around the virus to trick users into clicking on links in spoofed emails that claim to contain information on how to protect yourself from the spread of the disease. Read more about the attacks.

 

Staff, faculty and students should use caution when receiving any communications that appear to be urgent or demanding in nature. Please report any suspicious emails to the IT security offices using the “Report Phish to Duke” button, located in your Outlook email toolbar.

 

Staff, faculty and students can monitor Duke’s response to the coronavirus outbreak by visiting the university’s official site: https://sites.duke.edu/coronavirus/. Additional information is available at the Center for Disease Control (CDC) official website:  https://www.cdc.gov/

 

OHRP Public Outreach Materials

OHRP’s public outreach webpages, About Research Participation, have been updated.  The pages include informational videos, infographics, a list of questions to ask researchers, and additional resources for people considering participating in research.  These materials are available free of charge for broad public consumption:  

www.hhs.gov/About-Research-Participation

 

Maestro Care Storyboard and Widescreen Communication

On February 19, 2020, Maestro Care will be updated to include the new Storyboard functionality and widescreen view.  As a result, patient Maestro Care records will have a different appearance.  Storyboard shows the patient’s “story” on the left side of the screen and adapts to the end user’s role and setting.  It replaces the patient header previously located under the Epic toolbar. 

This image shows the Maestro Care Storyboard screen

The Activities that previously appeared along the left side of the screen will now appear as tabs under the Epic toolbar.  Navigator functions previously located along the left side of the workspace are relocated immediately below the Activities tabs across the top of the workspace.  The widescreen view takes advantage of the wider screens on modern computer monitors.  Both Storyboard and Widescreen are designed to enable providers to work more efficiently by placing the tools used most often on a single screen to reduce clicks and the frequency of screen changes.

This image shows the Maestro Care navigation bar within the application.

Patients on Research Studies

1. Patients who are on one or more research studies are identified with a flask notification on their Storyboard. In addition, their Storyboard is tagged with a pink banner indicating information about the research study – Pre-consent or Active.

 

2. Patient storyboards are tagged with a green “Restricted Communication” banner when the patient has opted out of being contacted about research studies. This does not preclude their provider from discussing research opportunities with them. Note that a patient can have both a green “Restricted Communication” banner and a flask notification & pink research participation banner.

This image shows the Maestro Care Storyboard flask identifier.

 

For more information on Storyboard and widescreen, check out the following information tip sheet, videos and slides.

 

DOCR Tip Sheet - https://ori.duke.edu/wiki/display/MCFR/Maestro+Care+Research+Tip+Sheets?preview=/22652312/85786912/Tip%20Sheet%20for%20Storyboard%20and%20Widescreen%20View.pdf

 

Videos

 

PowerPoint

https://ori.duke.edu/wiki/pages/viewpage.action?pageId=16369151&preview=/16369151/85786913/Feb%202020%20Storyboard%20Ambulatory.pptx

 

NIH Funding Opportunities

Do you have a promising point-of-care medical technology in need of further development?

 

The NIH’s Point-of-Care Technology Research Network (POCTRN) drives the development of point-of-care technologies through collaborative efforts that merge scientific and technological capabilities with clinical need. The goal of the Point Of Care Technology Research Network is to develop technologies with clinical applications using a network model that enhances complementary strengths and builds multidisciplinary partnerships.

 

POCTRN announces new solicitations from its four Centers:

 

Development of Point-of-Care (POC) Testing for HIV and co-morbidities for use in low- and middle-income countries
The Center for Innovation in Point of Care Technologies for HIV/AIDS at Northwestern (C-THAN)

Microsystems-based Point-of-Care Testing for Acute Emergency and Critical Care Medicine
Atlanta Center for Microsystems Engineered Point-of-Care Technologies (ACME-POCT)

2019 Award Competition: Center for Advancing Point of Care Technologies in Heart, Lung, Blood and Sleep Disorders - Pilot Funding Opportunity
The Center for Advancing Point of Care Technologies in Heart, Lung, Blood, and Sleep Disorders (CAPCaT)

 

Strategic Improvements to Rapid Simple Point-of-Care Tests for Sexually Transmitted Diseases (STDs)
Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases

 

Expressions of Interest are due March 2nd, 2020

More information can be found at the following websites:

https://www.nibib.nih.gov/research-funding/point-care-technologies-research-network

https://cimit.net/web/poctrn/home

 

Four Points Innovation Celebration, March 5

Duke’s Office of Licensing and Ventures announces a celebration event where leaders from Duke and Deerfield Management come together to commemorate the creation of a major translational research collaboration.

By way of a newly launched company–Four Points Innovation–up to $130 million will be made available by Deerfield to accelerate the preclinical development of new drugs coming out of Duke.

This celebration event will take place Thursday, March 5th, 4:00 PM – 6:00 PM, Champions Club at Cameron Stadium.  Click for more information and to RSVP for the event.
 

NC TraCS Institute to Sponsor Community and Stakeholder Engagement Events for Partner Sites

The NC TraCS Community and Stakeholder Engagement (CaSE) Program works to promote and support community-engaged approaches to clinical and translational research and build capacity for researchers and communities to engage in academic-community partnerships.

Qualitative Research 101, February 20th, 10:00 AM – Register

Qualitative research methods are often used when conducting community-engaged research.

During this online presentation, MaryBeth Grewe, MPH, CaSE Qualitative Research Specialist will provide an introduction to qualitative research methods. This presentation will discuss the differences between quantitative and qualitative research and provide an overview of qualitative research methods, including qualitative research methodologies, strategies for data collection, and methods of analysis.

 

Semi-Structured Interviewing Online Workshop, March 10th,  10:00 AM – Register

This interactive workshop will focus on semi-structured interviewing, a data collection method used in qualitative research. We will cover basics of semi-structured interviews, development of interview questions and probes, interviewing skills, and trauma-informed interviewing. Participants will have the opportunity to practice developing interview questions and using interviewing skills.

This event will be led by MaryBeth Grewe, MPH and Ginny Lewis MSW.

For both events the Webinar link will be emailed to registrants before the day of the event.

 

Duke Reach Equity Center Funding Opportunities

Application Deadline: March 30, 2020

One-year awards for investigators at every career stage are available for July 2020 funding:

Supporting research which promotes health equity. Applicants for all awards should propose research broadly related the REACH Equity Center theme, available here.

  • Research Vouchers: Up to $12,500 to supplement currently funded or standalone research. Faculty at any level. Full RFA is available here.
  • Research Scholars Development: Up to $5,000 for a project with faculty mentor identified by trainee. Residents, Fellows, Postdocs, Nursing and other Trainees. Full RFA is available here.
  • Transdisciplinary Think Tank: Up to $1,500 to foster collaboration across disciplines and develop research proposals. Faculty at any level. Full RFA is available here.

Contact: Cheryl Miller, cheryl.j.miller@duke.edu

 

Clinical Research Training Program Accepting Applications

The program is now accepting applications for academic year 2020-2021. 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.

This year CRTP is launching the Basic Science Research Track (BSRT), a customized curriculum designed for physician scientists and trainees leading to a Master of Health Sciences in Clinical Research Degree.

The application deadline for priority review is May 15, 2020. Applications will be accepted through August 1, 2020.

 

Community Consultation Studio (CCS)

An upcoming Community Consultation Studio (CCS) is seeking input from parents of teens.

A Traumatic Brain Injury Research study (a clinical trial)

Comparing two alternative strategies.

Previous Injury Not Required

This is the BOOST Logo

Topics for Feedback:

  • Inability to give consent
  • What would you want to know about this study
  • Concerns about treatment approaches

Please join us February 20th, 2020, 4:00 PM to 5:30 PM, free parking and snacks provided along with $50 payment for your time.

Contact: daphne.lancaster@duke.edu / 919-668-1564

 

IRIS/ONCORE UPDATES

 

Policy Update:  Participant Status and Study Visit Documentation in OnCore

The Participant Status and Study Visit Documentation in OnCore policy was recently updated.

The addition of the Not Eligible/Eligible status will provide additional metrics to appropriately calculate screen failure rates for reporting dashboards such as Insights.

 

iRIS Determined Exempt – Transitional Status

Have you seen a new Protocol Status in iRIS: Determined Exempt – Transitional?  

This images shows the iRIS Determined Exempt Transitional Status button

The IRB has started to exempt some studies during their continuing review in accordance with the Revised Common Rule.  These studies have a “Determined Exempt – Transitional” status in the iRIS header bar.

DOCR will change the status to “abandoned” in OnCore with “Exempt-Transitional” selected as the reason.

If the study has participants enrolled, the abandoned status is not available. In those cases the status will be changed to “IRB study Closure” with the reason assigned as “Exempt-Transitional”   

 

DOCR NEWS

 

Research Professionals Network:  Strategies for Building a Successful Portfolio for Tier Advancement

Thursday, February 20th , 1:00 PM – 2:00 PM, Trent Semans Center Great Hall

This session will focus on strategies for building a successful portfolio for Tier Advancement. In addition, this session will feature a break out time with tables that have RPLs (Tier 2), CRCs (Tier 3), Regulatory Coordinators (Tier 3), and CRNCs (Tier 3) who have successfully gone through the tier advancement process and had to build portfolios. Attendees will be able to ask for advice from those who have been through the process successfully.

 

Express Start Onboarding Program for the Regulatory Coordinator

We have now officially launched The Express Start Onboarding Program for the Regulatory Coordinator! The modules are now available in the LMS and may be signed up for utilizing this link-

Register Here. Courses may also be registered for individually. Links will be provided below.

The Express Start Onboarding Program for the Regulatory Coordinator consists of four self-paced e-learning courses that will provide an overview of clinical research activities, regulations, and workflows at Duke. Some of the topics include:

  • Roles and responsibilities
  • Clinical research organizations structure at Duke Medicine Central offices and resources
  • Clinical research systems; with a spotlight on iRIS
  • Applicable standards, guidelines, regulations, policies, and procedures for performing clinical research at Duke
  • Career progression within clinical research professions

The Courses

  • What is a Regulatory Coordinator at Duke? – Register Here
  • Navigating Clinical Research at Duke for the Regulatory Coordinator – Register Here
  • Introduction to the Clinical Research Workflow for the Regulatory Coordinator – Register Here
  • Institutional Regulatory Policies and Procedures in Clinical Research Management – Register Here

 

RECRUITMENT INNOVATION CORNER

 

Trial Innovation Network (TIN)

Are you ready to design a multi-site trial or study?  Want to collaborate with other academic health systems but aren’t sure where to start or unsure of where your target population is? Check out the Trial Innovation Network!

Duke is a member of the Trial Innovation Network (TIN), which is an innovative, collaboration across 70 CTSAs in the U.S. They help transform and translate innovative trials and studies into lifesaving therapies, ground-breaking discoveries and more!

This is an artistic image of people collectively generating ideas.

The TIN can help with:                  

  • Coordinating your multi-site study
  • Cohort discovery across CTSA institutions 
  • Finding like-minded investigators willing to help    
  • Creating a single IRB system       
  • Master contracting agreements
  • Quality by design approaches
  • Efficacy-to-Effectiveness (E2E) trial design
  • Evidence-based strategies for patient engagement and recruitment

The Trial Innovation Network is a national network that focuses on operational innovation, operational excellence and collaboration that will leverage the expertise and resources of the CTSA Program.  Duke has had over 20 collaborations to date and is continuing to grow every year. 

This image graphically shows the three step process for working with the Trial Innovation Network.

Ready to get started? Contact the Recruitment Innovation Center to find out more information and to start collaborating today! 

 

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

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 Population Health Center welcomes Research Program Leader Andrea Des Marais to the Opioids group.
Neurosurgery Clinical Research Unit welcomes Alyson Hignight.  Aly came on board December 9th as a CRC for the Shaffrey Spine group. We are thrilled to have her on our team!
The Department of Medicine CRU welcomes the following staff:

The following staff recently joined the Pulmonary division: 

Alexis Paterson, CRS, Sr
Lerin Eason, CRC
Bryonna Jackson, CRS, Sr
Dominick Bresson, CRS, Sr
Samantha Womack, CRC

The following are new members who have joined the research team at DMPI:

Kelsey Ball, Exercise Physiologist
Liezl Fos, CRS, Sr
Katherine Collins, Post-doc
William Bennett, Exercise Physiologist
Carola Ekelund, CRS
Alyssa Zidek, CRS

Erin Burks is a new CRC in GIM
Jamie Lamkin is a new CRS, Sr in Center for Aging
Allison Fullenkamp is a new RPL in CAGPM
Ashley Pifer is the new CRC Team Lead in ID
Stephanie Padrick is a new CRNC in Hematology                
Congratulations to Arvind Mallikarjunan who was promoted to CRS, Sr in Hematology

 

PARTNER RESOURCES

 

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

This image shows the corner of a Duke West Campus Building.

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