Clinical Research Update - December 2018

Thursday, December 6, 2018
By Duke Office of Clinical Research (DOCR)
Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

Research Community News
DOCR News
Did You Know?
Training Opportunities
Clinical Research Employee Highlights
Partner Resources


Research Community News

 

Migration of Study Documents from Legacy eIRB to iRIS

IRB Staff have begun moving copies of all last-approved study documents, except for consent forms, from Legacy eIRB to iRIS.  We are currently migrating documents on all open, approved, non-exempt studies.

Consent forms will continue to be migrated at the time of continuing review, if they have not been amended in iRIS since “Go Live”.  Research summaries and waivers will not be moved as this information is now part of the iRIS study application.  In addition, if a document has been revised in iRIS since “Go Live”, the previous documents will not be migrated.

The IRB will notify PIs/Coordinators when their study documents have been migrated into iRIS.  At that time, we will ask you to confirm whether all your study documents were moved correctly.

Please contact your IRB Specialist for any questions:  https://irb.duhs.duke.edu/about-us/staff-and-chairs

 

Clinical Quality Management Program (CQMP)

The Clinical Quality Management Program (CQMP) was established to develop and implement a comprehensive, standardized clinical research monitoring program to replace the Quality Assurance Monitoring Review Standards for Clinical Research Policy. The Clinical Quality Management Program pilot CRUs received training in July 2018 and we are rolling out the program to additional CRUs via bi-monthly training sessions. The program focuses on helping CRUs develop Clinical Quality Management Plans for all consenting and prospective studies that are not externally or independently monitored and that do not have ongoing approved monitoring plans. These plans focus on identifying key quality indicators, like the informed consent process, participant eligibility, and safety reporting that may affect study conduct.  A designated trained Quality Management (QM) reviewer will conduct regulatory file and participant chart reviews at predetermined time points. For questions regarding the CQMP, please e-mail CQMP@duke.edu.

 

OnCore Financials:  Radiology Pricing for Clinical Trials

The School of Medicine Finance Office has become aware that individuals are using the Charge Master Look Up report to obtain pricing for Radiology services and not submitting a request for Radiology review.

Radiology procedure codes, separate from CPT codes, are a fundamental part of ordering, scheduling, billing, and image interpretation that the study team may not be familiar with and that impact how a procedure/test are budgeted.

If you bypass this step, you risk incorrectly or under budgeting a Radiology procedure/test.

Moving forward, when you are first getting pricing information you should be obtaining the correct CPT and HCPCS codes through the Radiology Implementation Review process.   A link to the form is available on the Radiology Research Support website here.

Please email SOMFClinicalResearch@dm.duke.edu with any questions.

 

CITI Training:  Make Sure You Affiliate with Duke Health

Duke University has several affiliations within the CITI Program.  If you are submitting a protocol through the DUHS IRB and are adding Key Personnel to that study, it is imperative that all personnel associated with the study are affiliated with Duke Health in CITI.  This will ensure that their CITI account is populated with the Duke Health required modules.  These required modules must be complete for all Key Study Personnel before the protocol can move forward to CRU Review.

To access your CITI Account, select the LOGIN button from the CITI Program page at https://citiprogram.org.  Next, click on Log In Through My Institution.

Find Duke Health in the list and click on the link to go to the Duke Health log in page. You will authenticate through Shibboleth and be redirected to the CITI Program website.

More information can be found on the DOCR CITI Training Support Page.

 

Sharing Clinical Trial Data for Open Access Through Vivli

A new data-sharing and analytics platform launched by Vivli, a nonprofit organization in partnership with the Duke School of Medicine, allows researchers to store and share clinical trial data across all diseases, nations and research entities. Join us for a discussion on Mon. Dec. 17th to learn more!

Vivli informational webinar 
Mon, Dec 17, 2018 12:00 PM - 1:00 PM EST 

Join the meeting from your computer, tablet or smartphone
https://global.gotomeeting.com/join/272728853 

You can also dial in using your phone
United States: +1 (646) 749-3117 

Access Code: 272-728-853 

First GoToMeeting? Let's do a quick system check: 
https://link.gotomeeting.com/system-check 

 

eGRC SSN Exception Request closure

Remember to close your SSN Exception Request in eGRC when you are no longer collecting SSNs.  There is no expiration date when the SSN Exception Request is for payment of study subjects, so renewal notices are not automatically generated.  Therefore, the study team needs to go into the eGRC and close the request.

 

Mobile Technology in the Treatment of Addiction

Description: The Mobile App Gateway is bringing together a group of clinician researchers to discuss the ways that technology has assisted them in understanding and treating different types of addiction and addiction prone behaviors. Join Devon Noonan, Associate Professor in the School of Nursing, Dr. Eric Elbogen, Professor in Psychiatry and Behavioral Sciences, Dr. Joseph McClernon, Professor in Psychiatry and Behavioral Sciences, and Dr. Matthew Engelhard, Senior Research Associate in Psychiatry as they discuss tobacco use, opioid use, and pain management. Time will be allotted for a Q&A with the panelists after their presentations. Lunch will be provided.

Where: Trent Hall 040 – 310 Trent Drive

When: December 11th, 2018, 12:00 PM - 1:00 PM

RSVP Here

 

RFP for Duke Collaboratory Funds

The Duke Collaboratories RFP for this year has now been released. This is the second year for the Collaboratories, which is one of several faculty RFPs being offered through Together Duke. Last year, six faculty groups were awarded multi-year Collaboratory grants.

Collaboratory grants provide support for groups of faculty working on more established projects that seek to provide tangible solutions to targeted problems in 3 areas: 1) Energy & Water Resources;  2) Race, Religion & Citizenship; and 3) Population Health.

Duke has the intellectual resources and organizational nimbleness to convene technical, legal, scientific, ethical, cultural and historical explorations of these issues. By drawing on disciplinary depth, interdisciplinary strengths, and commitment to engagement, we have the capacity to make crucial research contributions in these vital areas and to serve as an important node for convening stakeholders.

Project funding ranges from $20,000 to $200,000 annually.

The deadline to submit proposals is February 15, 2019.

Questions may be directed to Carolyn Mackman at carolyn.mackman@duke.edu.

 

Translating Duke Health Pilot Grants in Immunology

Duke Health invites proposals for innovative approaches to supporting immune health.  This RFP is designed to invest in transformative areas of research and technology where Duke Health can have the greatest impact on human health.

Translating Duke Health is one of the signature programs animating Advancing Health Together, our Duke Health Strategic Planning Framework.  Translating Duke Health is a multiyear, multidisciplinary program to capitalize on our collective strengths in research, clinical care and population health to address major health challenges.  Additional information about Translating Duke Health is available at www.translatingdukehealth.org.

For this call, we are focusing on new approaches that could bear on our understanding of transplantation tolerance, tumors, autoimmunity, and protective immunity.  To be responsive to this RFP, projects should include an aspect of human immunology.  Applicants are also encouraged to take advantage of available biobank samples and Duke Core Facilities.

The steering committee is looking for projects that build new collaborations and/or new teams and might lead to extended productive (and NIH-funded) collaborations. 

Deadline: Proposals must be received by 5 PM EST, March 1, 2019

Questions and completed applications should be submitted as a combined pdf file to: translatingdukehealth@duke.edu.

 


DOCR News

 

 

REDCap Hits 7000 Projects

We have created more than 7000 projects in REDCap; this milestone was reached four months earlier than expected. We are thrilled the growth continues as faculty, staff, and students are using it to collect their research data securely.

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.

 
iRIS Office Hours Available

The Duke Office of Clinical Research will host Office Hours twice per month beginning in December.  Instructors will be available to assist end users with general questions regarding using the iRIS system to submit protocols to the DUHS IRB.  Please bring a laptop if possible along with your protocol specific questions to the sessions.

Dates and locations for December and January are:

  • December 10, 11 AM – Noon, DMP2W93
  • December 17, 11 AM – Noon, DMP2W91
  • January 7, 11 AM – Noon, DMP 2W91
  • January 14, 11 AM – Noon, DMP 2W91

 


Did You Know?

 

 

REDCap:  Survey Specific Email Invitation Field

A survey-specific email invitation field can be enabled for any given survey, in which you can designate any email field in your project to use for sending survey invitations for that particular survey. Thus, you can collect several email addresses (e.g., for a student, a parent, and a teacher) and utilize each email for a different survey in the project. Then you can send each person an invitation to their own survey, after which all the survey responses get stored as one single record in the project.

The survey-specific email field is similar to the project-level email invitation field with the exception that it is employed only for the survey for which it has been enabled. In this way, the survey-level email can override an existing email address originally entered into the Participant List or the project-level email field (if used). This feature allows users to have data entry workflows that require multiple surveys where the participant is different for each survey. (Note: The email field can exist on any instrument in the project, and you may use a different email field on each survey. You may also use the same email field for multiple surveys.)

Survey-specific emails can be designated in the survey settings:

Note: This option will override the project-level email invitation field (if enabled on the Project Setup page) and will also override any email address originally entered into the Participant List. Also, if this field has no value and the project-level email field is enabled, then the project-level email field's value will be used instead.

 


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 Duke Early Phase Research Unit (DEPRU) would like to welcome new staff: Connie Separk, DEPRU Financial Practice Manager, Corey Lipscomb, Regulatory Coordinator, Daniel Gonzales, Clinical Research Nurse Coordinator, Luke Drake, Clinical Nurse, Naomi LaMunion as Clinical Research Coordinator and Moryelle Coley-Greene as Certified Medical Assistant.  Welcome to DEPRU.

The School of Nursing CRU congratulates Caroline Bishop who has been promoted to ARPM.

 

 


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.

 

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