Duke Clinical Research Update

Wednesday, August 7, 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

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

 

Pregnancy Testing and Contraceptive Use in Research

The Pregnancy Testing policy, the Contraceptive Use policy, and the Contraception standard language used in consent forms (for females and males) have been updated.  They have been posted on the IRB web site https://irb.duhs.duke.edu/, and the policies now reflect the reproductive risk review that Dr. Evan Myers (OB/GYN) is doing in iRIS, prior to a new study arriving at the IRB.  For questions about pregnancy testing and contraception plans, or the related ICF language, please contact Dr. Myers at evan.myers@duke.edu.

 

Recruitment and Engagement Policy:  Modifying Recruitment Plans

The graduated roll out of changes to subject recruitment completed in June 2019.  All CRU’s can now modify existing study recruitment plans or submit new studies with a recruitment plan that conforms with the updated policy.

Study teams interested in utilizing updated strategies for recruitment will need to complete the following steps:

  • All key personnel must have completed the online training.  Links to training and tip sheets outlining the process for submitting a training confirmation in iRIS can be found here.
  • The IRB application should outline the specific procedures that will be used for recruitment of subjects.
  • Patient opt-out status within Maestro Care is reviewed before potential subjects are approached or communicated with.

DOCR is studying the impact of changes to the recruitment policy under an approved protocol.  If you are modifying your recruitment plan in alignment with the new policy, please contact Michelle Mack (michelle.mack@duke.edu).

 

 

iThenticate for Authors and Researchers

Ready to submit?

Run your paper or grant proposal through iThenticate before sending somewhere else

iThenticate Duke Office of Clinical Research (DOCR)

Whether you are a researcher, grant manager, student, or faculty member, iThenticate helps you detect un-cited or improperly cited material in manuscripts, grant proposals or other written documents so that you can correct the text before it is submitted. This is particularly useful because publishers and funding agencies, such as NSF and NIH, use plagiarism detection tools to screen manuscripts or grants upon submission. iThenticate can serve as a learning tool, to help you identify sections of your writing that may need additional editing or re-writing when the tool detects text matches to other published texts.

Duke University has chosen iThenticate as the anti-plagiarism tool for the Duke research community, enabling early detection of possible plagiarism before works are disseminated.

Learn more about how iThenticate works and how faculty and staff can get access at no cost, on the ASIST webpage.

 

 

DUHS Clinical Labs Bi-Annual CAP Accreditation Completed and Available for Download and Filing

If you are involved in an ongoing research study that is utilizing the DUHS Clinical Labs (Duke University Hospital Site), you likely need to keep the current proof of CAP and CLIA certification documents on file.

Check to see whether any CAP or CLIA certificate(s) that you have on file may have recently lapsed.  If so, go to the Duke Clinical Laboratories Accreditation (CAP/CLIA) page to download any of the most the most recent CAP and CLIA lab accreditation documents from more than twenty different labs across the Duke Health systems.  If needed, the CAP certificate from the Duke University Hospitals Clinical Laboratories renewed in June of 2019 can be found here.  

If you are working on a sponsored clinical trial, check with your study monitor to see if they require you to send in updated CAP/CLIA certificates.

 

Grant Submission Planning Studio

Planning a grant submission?

Have a research idea but aren’t sure where to start to turn it into a fundable proposal?

Need to know more about the logistics and feasibility of your project?

Attend a Grant Planning Studio!

The CTSI’s Grant Planning Studios have been designed to envelop Duke Investigators with CTSA supported resources and services and foster the development of great research proposals. Custom-tailored one-hour studio sessions will connect you with experts from CTSI Cores, Duke research support resources and faculty who will work with you to turn your research question into a robust funding proposal.

Learn more here.

Interested in attending a custom-tailored studio? Apply here for the September 30th Studios.

 

Funding Opportunity at Duke for Junior Faculty, Fellows, and Postdocs

Open Scholar Position on the KURe: Multidisciplinary K12 Urologic Research Career Development Program (KURe-K12). This Career Development Award (NIH-K12 mechanism) is administered by Duke and funded through the NIH-NIDDK. The KURe is open to all types of disciplines, clinicians and non-clinicians with doctoral degrees. We strongly encourage applications from members of groups underrepresented in the biomedical sciences.

Applications Due: September 13, 2019

Letter of Intent (Required) Due: August 12, 2019

The KURe is seeking qualified clinical, translational, and basic science researchers from diverse disciplines who are interested in building an independent research career using collaborative, multidisciplinary approaches to benign urological research questions. MDs, DOs, PhDs and MD/PhDs (junior faculty, fellows, and postdocs) from any department and interested in research applicable to benign urology may apply to the KURe program. KURe Scholars will receive mentoring and salary support up to $100,000 per year for 75% of full professional effort (50% - 75% if a surgical specialty). Research and Career Development Support up to $40,000 per year will be provided for research supplies, equipment and technical personnel, tuition and fees related to didactic courses or career development, and travel to research meetings. Scholars are expected to publish and apply for independent grant funding by year 3. Maximum support is for 5 years. The target date to appoint a new KURe Scholar is November 2019. For additional information see KURe.medschool.duke.edu or contact friederike.jayes@duke.edu or cindy.amundsen@duke.edu

 

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:​​

  • August 26, 11 AM – Noon, DMP 2W91

 

New iRIS Tip Sheets Available

Two new iRIS tip sheets are available:

  • Attaching the IRB Initial Application to an Amendment Form—this tip sheet outlines the process for attaching the Initial IRB Application to an Amendment form.  In addition, when the CRU or IRB request modifications to the Initial Application during an Amendment submission, the tip sheet outlines the process for attaching the Initial Application to the Amendment form. 
  • Hide and Unhide Documents—this tip sheet shows users how to hide/show consent documents and other protocol documents in the iRIS system.

 

Change to Institutional Biosafety Committee Annual Review Notifications

Study teams will continue to receive notifications for Annual Renewals 30 days, 7 days, and 1 day prior to protocol expiration.  Annual Renewal notifications will no longer be sent out 60 days prior to the protocol expiration date. 


DOCR News

 

Ordering Urine Pregnancy Kits from the Duke Office of Clinical Research (DOCR)

Beginning August 7th, Clinical Research Units will complete a REDCap survey to order urine pregnancy kits from DOCR using this link:

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

The survey includes a place to list the names of everyone who will use the kits to screen patients and a link to upload a completed Interdepartmental Requisition (IR) form to cover the cost of the kits.  DOCR will check the Duke Learning Management System (LMS) to confirm that the person ordering the kits and everyone listed to use them has completed Urine Pregnancy Screening for Research training within the previous year.  At least one person listed on the order must have current training for DOCR to dispense the kits.  If no one listed on the order has current training, the kits will be dispensed when at least one person has renewed their training.  Please allow at least five business days for orders to be filled.  This time will be extended if training is required before kits are dispensed.  Contact DOCR-Training@dm.duke.edu if you have questions regarding the status of your team members’ training or questions regarding urine pregnancy screening or kits.

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REDCap Hits 8000 Projects

We have created 8000 projects in REDCap. The growth continues as faculty, staff, and students are using it to collect their research data securely.

REDCap 8000 Projects

 

REDCap is a HIPAA compliant, secure web application for building and managing online surveys and databases. Learn more about by watching a brief video.

REDCap can be access at https://redcap.duke.edu and a practice project can be requested here.

 


Did You Know?

 

REDCap:  Surveys and Dedicated Study Email Addresses

When sending out surveys, it is best practice to have a dedicated study email that can be included in the from line.  Instead of surveys going out from an individual’s personal email, work with IT to get an email address for the study and mailbox set-up in Outlook. 

Once you have an email created, it needs to be added to the profile of anyone who has REDCap access to the project:

  1. Log into REDCap
  2. Go to My Profile (top right corner)
     
  3. Click on Add email for Secondary email
     
  4. Enter email, confirm it, and click Add email
     
  5. It will need to be verified by going to the email box
     
  6. You will receive an email to verify
     
  7. Once you click on the link, your account will be verified 
  8. When you compose an email, it will now be available 

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 School of Nursing welcomes Pedro Gomez as a Clinical Research Specialist, Sr.

  • The Department of Medicine CRU welcomes Jenny Exelbierd as a new ARPM beginning July 22, 2019

  • The Department of Medicine CRU announces Susana Almeida-Peters was promoted to CRNC, Sr. in Pulmonary effective July 1, 2019


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.