Duke Clinical Research Update

Wednesday, December 18, 2019
By Duke Office of Clinical Research (DOCR)
Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

 

 

 

 

 

Support Office Hour

 

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

 

Slicer Dicer Office Hours

Thursdays | 1 pm | Erwin Square Room 1022 | via WebEx
 

PACE Office Hours

Every other Tuesday, 1 PM, via WebEx. More information.


Research Community News

 

Coverage Analysis (CA) and Payment of Copayments & Deductibles Policy Updated

The Coverage Analysis (CA) and Payment of Copayments & Deductibles policy located on the DOCR website was recently updated. The revision to the policy includes: Studies in which all procedures/services associated with the study are reimbursed by the sponsor will not be charged the Coverage Analysis fee. For additional information and/or questions, contact DOCR.help@dm.duke.edu.

 

Have you heard of the Duke Insterdisciplinary Behavioral Research Center (IBRC) at the Social Science Research Institute?

The IBRC at Erwin Mills may be one of the best free Duke resources you’ve never heard of! It is great for researchers working with community participants, focus groups, and computerized tests.

The IBRC offers free lab space to researchers, including:

  • 20 testing rooms and 1 conference room with 65 inch monitor
  • A break-room/kitchen with fridge, cabinets, microwave
  • 2 psychophysiology recording rooms (HR, RR, BP, skin temp, GSR, EMG, ECG, finger pulse amplitude)
  • Computers equipped with MediaLab, DirectRT, E-Prime, and Inquisit
  • Millisecond keyboards for reaction time measurement and updated video cameras
  • 8 Lenovo laptops available for mobile/off site use
  • Free parking/access to bus line
  • A 37ft air-conditioned/heated Mobile Research Laboratory with soundproofed cubicles, each capable of holding 2 people

The facility isn't equipped for biological sampling (e.g., blood draws) but is otherwise available for behavioral research and physiological measurements described above. They also offer help with study design, research assistants and small grants to help you pay participants.

Interested in learning more? Ready to schedule a tour of the space?

Contact Ellie Farmer, IBRC Research Coordinator: kef44@duke.edu

Contact Patty Van Cappellen, IBRC Director: patty.vancappellen@duke.edu

 

CITI Single IRB (sIRB) Course Now Available for Duke Health CITI Users

Duke Health has acquired access to the CITI Single IRB (sIRB) Course for all Duke Health CITI users.

This optional course provides an overview of the use of Single IRBs in relation to the 2018 National Institutes of Health (NIH) policy requiring sIRB review for most human subjects research it conducts or supports, which significantly expanded the number of studies requiring sIRB review and anticipated.

For those interested in taking the sIRB module in CITI:

  1. Go to the CITI Program website: https://www.citiprogram.org
  2. Login to CITI correctly using the blue Log In button in the top right corner of the screen
  3. Select Log In Through My Institution
  4. Scroll to select Duke Health as your Institution
  5. Shibboleth authenticate with your NetID and password

Logging in via these steps will ensure that you will be able to access the sIRB training through your Duke Health CITI account.

To add the new course to your learning:

  • Go to Institutional Courses
  • Select the View Courses button next to Duke Health
  • Scroll to the bottom of the page
  • Under Learner Tools for Duke Health, select Add a Course
  • Select Single IRB, then Next

This will add the course to your list of available CITI courses.

For additional information about the CITI Single IRB (sIRB) Course, visit https://about.citiprogram.org/en/blog/getting-ready-for-the-common-rule-single-irb-requirement/.

 

CTSI Offers Grant 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?

Come to a Grant Planning Studio!

The CTSI will be offering Grant Planning Studios every 4 months on the 2nd Monday beginning February 10th. Grant Planning Studios foster the development of innovative ideas and build a foundation for great research across the Duke community.  Faculty and program leaders of CTSA-supported core resources and other Duke research services will be available to discuss and collaborate on designing a research proposal with invited research teams.

The next Studio Session will be held on February 10, 2020 and will include leaders from CTSI Cores and Duke research support resources, leveraging their expertise and experience throughout each of the customized 1-hour Studios. Your Studio will be tailored to your needs based on your application and subsequent discussions with the GPS Coordinators about your needs.

As invited faculty, you will have the opportunity to discuss the design and logistics of your research question and study proposal during your assigned Studio. In addition, you can make connections and build collaborative relationships with research staff and faculty who will work with you to turn your research question into a robust funding proposal by leveraging CTSA resources.

The deadline to apply for the February 10th session is January 13th.   If you have more emergent needs, there is a Rapid Response Team that can work with you.

Apply to attend a Studio >>  https://www.ctsi.duke.edu/gps

IRIS/ONCORE UPDATES

 

iRIS FAQ: My study team member has completed all of their CITI training, but I do not see their name on the KSP pick list. What is going on here?

A study team member’s name will not appear in the iRIS system until they have logged into the iRIS system for the first time (regardless of their CITI training completion status).

To have a study team member’s name appear on the iRIS Key Personnel pick list, they must log into the iRIS system using their Duke Net ID and password. This initial login will create and iRIS account for the study team member and their name will appear on the Key Personnel pick list.

Logging in for the first time will also map the person’s CITI training into the iRIS system. If for some reason the training does not map, submit a Service Now ticket to have their CITI training manually mapped to iRIS.

 

Did you update a subject in OnCore but the change is not showing up in Maestro Care?

The most common reason is that you or someone else is in the research studies record.

The first step is to get out of the research studies tab in Maestro Care. You can click in a different tab or close the record.

You can resend the information from OnCore by opening a status tab (consent, eligible, on study, etc.) for the subject in the Subject Console, clicking on the Update button, then clicking on the Submit button. You don’t have to change anything. The record will be sent again.

Still having problems? Submit a Service Now ticket:

https://duke.service-now.com/sp?id=sc_home

  • GET IT
  • Select the Research category
  • Select OnCore Support

A link is also located in OnCore. Click on the arrow in by your name in the far right side of the header. Go to Help and click on the Service Now Self Help form.


DOCR NEWS

 

Process Update:  Contract Amendments that Include Changes to Budget

As of January 1st, 2020, for contract amendments that include changes to the budget, we are asking that DOCR-Startup (DOCR-Startup@dm.duke.edu) be copied on the original email sent to the Agreement Manager in the Office of Research Contracts (ORC).

This notification will help DOCR-Startup to determine if changes are needed to the Protocol Calendar.  If applicable, it would be helpful if the amended protocol (preferably with tracked changes) be sent to DOCR-Startup when it is received.

For those using OnCore Financials, please make sure the Budgeter knows about the amendment with changes to the budget since a new Budget Version may be needed.

We appreciate your help in streamlining the amendment process so that delays may be avoided.

 

NEW in January 2020!  Express Start Onboarding for the CRC!

Do you remember when you started in a new role, and you were looking for some basic information to help you get started?  Workforce Engagement and Resilience has a new program designed to help a new Clinical Research Coordinator (and other clinical research professionals) with this!  The Express Start Onboarding Program will provide new hires in clinical research roles at Duke with self-guided online courses that can help orient them to the “lay of the land” of clinical research at Duke.  We have recently completed a successful pilot of this program and we are excited to open the enrollment to the Duke clinical research community in January!

The Express Start Onboarding Program 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
  • Portfolio management
  • Career progression within clinical research professions

The Courses

  • What is a Clinical Research Coordinator at Duke?
  • Navigating Clinical Research at Duke: What You Need to Know
  • Introduction to the Clinical Research Workflow at Duke
  • Getting Started with Your Clinical Research Portfolio

What People Are Saying

  • “I really enjoyed the content and found it to be very useful and helpful.  I wish something like this had been available when I first started at Duke.”
  • “I feel the content provided an appropriate overview of clinical research at Duke and job responsibilities of a CRC.”
  • “I specifically like the job role descriptions and responsibilities for each type of position (e.g. PI, RPM, ARMP, etc.).”
  • “Really well done! The overview of clinical research workflow and the “putting it together” section provides good context for a CRC.”
  • “I especially like the steps for how to review a study.  The checklists and documents are helpful to understand how to read a protocol and operationalize it.”

Please be on the look-out for registration information in January’s Newsletter!  The program and individual courses will be available for enrollment via the Duke LMS. 


RECRUITMENT INNOVATION CORNER

 

Have you written your letter to Santa yet?

The RIC invites you to tell Santa what you are wishing for to support your recruitment efforts using this short survey.  We’ll make sure Santa gets all your “letters” so he can put his elves to work building the toys you need.

 

Should Social Media Be in Your Recruitment Toolbox?

Patients are online, embracing social media and adapting their information-seeking and –sharing behaviors in the rapidly evolving digital landscape.  Because of this, social media is having a paradigm-shifting effect on clinical research, facilitating cross-cutting, multi-directional communication between patient, advocacy, researcher and clinician communities. Hence, social media can play a major role in informing potential participants about opportunities to engage clinical research.

Think older adults (e.g., over 65) aren’t on social media? Think again! One of the fastest growing groups on Facebook is senior citizens, nearly doubling between 2012 and 2019.

Are you considering using social media to recruit participants? Read this short article or this guidance to learn about some of the things you need to think about, then reach out to the RIC for advice about how to market your research more effectively using social media and other tools.


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 Neurosurgery CRU congratulates Anna Thirakul on being retitled from CRS, Sr. to a CRC.


PARTNER RESOURCES

Catch up on news from the DUHS Compliance Office.


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