Duke Clinical Research Update

Wednesday, July 17, 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 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

 

Clinical Quality Management Program (CQMP) Signoff Integrated into the Institutional Approval Process

As part of Duke’s research oversight initiative, the Clinical Quality Management Program (CQMP) has been integrated into the Institutional Approval signoff process effective July 1, 2019. Each Clinical Research Organization (CRU)/Oversight Organization (OO) is responsible for establishing a Clinical Quality Management Plan   for any prospective, consenting, clinical research study that is not externally-monitored or operating under an established monitoring plan. Retrospective, exempt and low-complexity studies that are internally-funded do not require a Plan. 

The CQMP will notify the Clinical Research Unit’s Research Practice Manager and/or designee if a Plan is required. All Plans must be completed and signed off in the Clinical Quality Management Database in REDCap before Institutional Approval will be granted in OnCore.

The updated policy and additional information about the CQMP can found on the Duke Office of Scientific Integrity’s website.  For questions regarding the CQMP, please e-mail CQMP@duke.edu.

 

Mobile App Gateway

The Mobile app Gateway (MAG), supported by CTSI, is now accepting proposals for projects looking to create native smartphone apps for clinical research studies. The awards will cover effort to build an app using new functionality for RedCap, called MyCap. MyCap is based on ResearchKit/Research Stack and can create iOS and Android apps.

Please visit https://www.ctsi.duke.edu/duke-mobile-app-gateway-funding-opportunity for more details.

 

 

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

 

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

Survey of CRC Role in Research

Shaunagh Browning MS, RN, FNP-BC, Director of the Office of Research Quality Assurance at Georgetown University, has created a 20-minute survey of CRCs for her DNP work. CRCs working in the United States or US Territories are eligible to participate.

“Are you a Clinical Research Coordinator (CRC) working in the United States or US Territory? 

A Clinical Research Coordinator (CRC) is a research professional with various specialty backgrounds, whose primary role, under the supervision of the Principal Investigator (PI), is the management, support, or conduct of clinical research. The CRC includes a variety of professionals that fulfill this role and might consist of a research professional, nurse, social worker, pharmacist, or other allied health professional. Although your title may not be CRC if you fulfill this role, you are considered a CRC for this survey.

If you are a CRC, I need you to help me understand more about your important role in clinical research by completing a 20-minute survey. The survey will collect data from CRCs, like yourself, about perception of roles, responsibilities, and competence in implementing clinical research activities in order to provide a description of current CRC practice. If you are not a CRC working in the US or US Territory, it would be appreciated if you could send this along to someone who is a CRC. 

TO BEGIN SURVEY CLICK ON LINK BELOW OR COPY AND PASTE TO YOUR BROWSER.  Please complete by August 1st. 

http://j.mp/2IBNS60


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

 

New Process for Review of Injury Language by Office of Research Contracts (ORC)

Beginning Monday July 22nd, ORC will be removed as a review committee in iRIS (for review of research-related injury language).  ORC will continue to perform injury language review outside of iRIS, via email communication with study teams.  The new process will require study teams to upload the injury language email they receive from ORC to the study document section in iRIS.  Instructions have been added to the DUHS IRB Application in iRIS, to guide study teams through the new process.  Prior to final approval, the IRB Specialist will conduct a review to determine if the research-related injury language in the consent form is consistent with the uploaded email.

For questions related to the injury language in your contract and consent forms, please contact your ORC Agreement Manager: https://medschool.duke.edu/research/research-support-offices/office-research-contracts/meet-team.

 

OnCore Minimum Footprint Report Requirements and Purpose Policy

The OnCore Minimum Footprint Report Requirements and Purpose policy has been updated to account for the limited data needed for Retrospective and Exempt study types.  This policy defines the purpose of, and requirements for, the Minimum Footprint Protocol Detail Report in the OnCore application for new and modified research protocols.

 

OnCore:  Did the CRU change for your study?

Study team members who are listed as Key Personnel on the study and have protocol management rights in OnCore can update the CRU listed for the study.  CRU updates do not come over from iRIS.


DOCR News

 

Research Staff Management in Maestro Care

New research studies:
Research staff are added to Key Personnel in iRIS when the study is first entered.  Key Personnel are then pushed into OnCore when the Sync button is clicked.  Those research staff individuals are then pushed from OnCore to Maestro Care, filling in ONLY the PI and Study Coordinators fields on the RSH record for the study. 

Existing research studies:
Maestro Care requires manual changes to the Users and Providers fields in the RSH record by an analyst in DOCR.  You will need to open a ticket in Service Now to request the addition or removal of research staff in Maestro Care (see link below for tip sheet).

Below are some examples of when research staff need to be on the RSH record:

  • Anyone who needs to add a timeline
  • Anyone that will link appointments or encounters to the research study
  • Anyone reviewing charges – Must be in the Study Coordinators section
  • Certain reports require the user to be on the RSH record
    • The patients needing coordinator review (RSH005)
    • The Appointment Search for Research Coordinators (RSH022) report

Please note that providers do not need to be on an RSH record to second sign orders.

*Use the following link to open the Maestro Care Tip Sheets page and open the “Requesting a User be Added to the RSH Record” document, detailing how to open the ticket in Service Now:

https://ori.duke.edu/wiki/pages/viewpage.action?spaceKey=MCFR&title=Maestro+Care+Research+Tip+Sheets

 

Research Wednesdays JA Credit Requests

The Research Wednesdays series offers Joint Accreditation Credits through Duke Continuing Medical Education.

Beginning with the July 24th Research Wednesdays session, the process for requesting and recording JA credits will change.  Moving forward, these credits will be requested and logged in the Ethos System and will not be recorded in the LMS.

Get a Jump Start!  Create your Ethos Account Today!

In order to receive JA credits for attending or live-streaming a Research Wednesdays session, participants must have created an account in the Ethos System using their Duke Net ID and password.

To create an account in the Ethos System:

Once participants have an account created in the Ethos System and have registered their cell phone numbers in the system, they will be able to text the session verification code on the day of the event to receive JA credit for attending or viewing the session.

JA credits will be recorded in the Ethos System.  Transcripts may be obtained by going to the “My Account” section of the Ethos website:  https://ja.dh.duke.edu/

 

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.