Duke Clinical Research Update

Wednesday, September 18, 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


 

EDCap 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


Research Community News

 

Gadolinium Risk Policy Updated

 

The Gadolinium Risk policy has been updated to reflect current understanding of possible risks related to the use of gadolinium based contrast agents.  Please refer to this policy when planning or conducting a research MRI that includes administration of a gadolinium based contrast agent.

https://irb.duhs.duke.edu/policies-and-regulations/policies/gadolinium-contrast-agents

The Gadolinium Risk Standard Language, for adults and for children, has also been revised, and is posted on the IRB web site under Standard Language.  Please incorporate this language as appropriate for your study, in new consent forms going forward.

https://irb.duhs.duke.edu/standard-language/english-standard-language

For questions, contact the IRB Specialist for your CRU:  https://irb.duhs.duke.edu/about-us/staff-and-chairs

 

Reporting a Privacy Incident

Earlier this year, DUHS Compliance assumed responsibility for HIPAA privacy incident investigations for the School of Medicine, including research. A privacy incident is any potential or actual loss of control, compromise, or unauthorized disclosure, acquisition, access of protected health information (PHI), whether physical or electronic.  As soon as you become aware of a privacy incident, even a seemingly minor or innocuous incident, you have a responsibility to notify DUHS Compliance (compliance@dm.duke.edu) immediately so DUHS Compliance can investigate, mitigate risk and resolve incidents without unreasonable delay.  We appreciate your cooperation to timely report privacy incidents!  

To report a privacy incident to DUHS Compliance you can do one of the following email compliance@dm.duke.edu or call 919-668-2573. You may also anonymously and confidentially report a privacy incident by contacting 1-800-826-8109.

 

Maestro Care Slicer Dicer Reporting Tool Now Available to CRNCs

SlicerDicer is a self-service cohort building tool within Maestro Care where study teams can see counts of patient populations.  Study teams that have an approved Review Preparatory to Research (RPR) or an approved protocol with the DUHS IRB can view potential participants’ PHI for research purposes.

The SlicerDicer tooI is currently available to clinical providers and it will be rolled out to research users in a phased approach.  It is already accessible to all CRCs with the Non-licensed Clinical Research Coordinator security template in Maestro Care and is also available to CRNCs with the Licensed Research Coordinator security template.  Research staff with the ONCBCN Research security template will soon have access to the tool as well.  Other research roles will have the opportunity to receive access as appropriate.

To see if you have SlicerDicer access, type “slicer” in the Chart Search box.

Here are access dependent links to SlicerDicer instructions:

DOCR is hosting SlicerDicer office hours on Thursdays at 1:00 PM.  Attend in person or join via WebEx using this link:  Join WebEx Meeting

  • Thursday, September 19, 1:00 PM – 2:00 PM - DOCR conference Room 1022 (Erwin Square 10th floor)
  • Thursday, September 26, 1:00 PM – 2:00 PM - DOCR conference Room 1022 (Erwin Square 10th floor)

 

Research Recruiters and CRCs Needed

The CTSI Community Engaged Research Initiative (CERI) is hosting a Community Consultation Studio in collaboration with Dr. Barrett Bowling.  Dr. Bowling would like to receive feedback from research recruiters and coordinators about barriers and potential solutions to recruiting and retention of the older adult population in studies for common chronic diseases.  The studio will be held on October 15, 2019, from 11:30 AM-1:00 PM in a Duke South location (TBD).  If you’re interested in participating please contact daphne.lancaster@duke.edu or call 919-668-1564.

 

 

FDA Humanitarian Device Exemption Webinar October 21st, Noon – 1:30 PM EST

The FDA will hold a webinar to discuss the updated Humanitarian Device Exemption Program Final Guidance issued September 5, 2019.

Registration is not necessary and following the webinar, a transcript, recording and slides will be posted at http://www.fda.gov/CDRHWebinar

For more information, go to the FDA website

 

Save the Date:  Duke Clinical Research Appreciation for Faculty and Staff

The annual Duke Clinical Research Appreciation Event for Faculty and Staff, “Navigating Your Path to Success”, co-sponsored by the School of Medicine and the Clinical Translational Science Institute 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.

 


iRIS/OnCore Updates

 

Policy Update:  Participant Status and Study Visit Documentation in OnCore

The Participant Status and Study Visit Documentation in OnCore policy was updated on September 6th.  The update clarifies the statuses required to be entered in OnCore for a participant who consents to a research study on the date the status changed.

 

Revisions to OnCore Protocol Type

The HUD/HDE or Single Subject IND category has been expanded into 3 categories:

Expanded Access – Individual patient: Includes individual emergency use, single patient INDs or compassionate use device requests.

Expanded Access – Multiple patients: Use for larger cohort-based protocols for expanded access, i.e., intermediate-size patient population INDs.

HUD/HDE: Humanitarian Use Device (HUD)/ Humanitarian Device Exemption (HDE).  A HUD is a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 8,000 individuals in the United States per year.”

An approved HDE authorizes marketing of the HUD for clinical use; however clinical use of the device is limited to the indication specified in the product labeling and the HUD may only be used in facilities that have an IRB to oversee the clinical introduction and use of the device within that institution.  

New Protocol Types have been added to the Non-Oncology Library.  They are not available in the Oncology Library due to specific NCI reporting criteria. A new tip sheet, Assigning Protocol Type in the Non-Oncology Library, with a decision tree has been posted on the DOCR OnCore Support Page.

Registry/Repository: A registry is a collection of information about individuals, usually focused around a specific diagnosis or condition. These may collect information about people who have a specific disease or condition, or be a list of people willing to be contact to participate in future research. A repository refers to collections of data and/or specimens that are collected, stored and distributed for research purposes.

Survey only: Research that is non-experimental in nature and only involves a survey. Survey only research may collect written consent from participants, or have a waiver and rely on implied consent.

Qualitative only: Research that rely on qualitative methods only, such as focus groups or key informant interviews. Qualitative research is primarily exploratory in nature, and the data collected in not numerical in nature.

Observational: Non-experimental studies in which behavior is systematically observed and recorded. This may involve direct observations, surveys, or measurements, but cannot include an intervention. 

 

Accessing iRIS Support

There is a new way to access iRIS Support. Click on the Help button, and then click the first link in the Help pop up. The link will display a support request form to complete that bypasses the Service Desk, and delivers your support ticket directly to the organization that can assist with your specific issue (ORI, DOCR or the Duke Health IRB team).  The help button also takes you to additional resources, forms and tip sheets to help with your work.

 

Need Help with OnCore?

You can now email OnCore@duke.edu directly to create a Service Now ticket.  One-on-one assistance is provided to anyone who contacts our team.  Often times, we are able to screen share via jabber or web-x to aid in the resolution of more complicated issues. 

Please don’t hesitate to contact us- we offer timely resolutions to your OnCore questions and concerns.  If you would like to request one-on-one assistance or training for your team, please email Kristy Astin and Susan Natoli.


DOCR News

 

Research Professionals Network:  Exploring New Technologies and Learning Opportunities

Wednesday September 18th at 1:00 in Trent Semans Great Hall

Join the DOCR Training and Communications team as we explore new technologies and learning opportunities available to the Duke community.  Learn more about Jabber and creative ways to use it in day to day work flows.  The Duke install of Jabber allows for services such as instant chat, video calls, desktop sharing, and conferencing capabilities.  It’s also possible to integrate with WebEx, allowing for online meeting launching.

Learn more about other technology training available to you through the newly designed Duke LinkedIn Learning portal.  This new portal allows access to services previously provided through Lynda.com, but is now integrated with LinkedIn for a unique learning experience.

Learn more about the Research Professionals Network

 


Did You Know?

 

REDCap Upgrades to Version 9.1

REDCap recently upgraded to version 9.1.  REDCap v9.1 has all the core functionality from previous versions plus many new features and improvements.  You can review a full list of these here.


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 Neurosurgery CRU welcomes Courtney Wimberly, CRC, working with Dr. Kyle Walsh

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.