Duke Clinical Research Update

Wednesday, August 21, 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
Training Opportunities
Partner Resources


Slicer Dicer Office Hours

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

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

 

Update to Prompt Reporting/Unanticipated Problems Policy

The IRB’s policy on Prompt Reporting was revised to eliminate inconsistent messaging about which safety events and protocol deviations must be reported to the IRB.  Please review the updated policy:  https://irb.duhs.duke.edu/policies-and-regulations/policies/unanticipated-problems.

Note in particular the following:

A Protocol Deviation/Violation must be reported to the IRB if it:

  • affects subject rights and welfare; or
  • affects subject safety; or
  • affects the integrity of study data; or
  • affects the subject's willingness to continue in the study; or
  • is specifically requested by a government agency, internal/external auditor, medical monitor, or the IRB.

Over-enrollment of study participants (i.e., exceeding the target enrollment) does not require the submission of a protocol deviation to the IRB but does require an amendment to increase enrollment.

The reporting timelines for when events must be reported to the IRB have not changed, and the reporting timelines can be found in the updated policy.

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

 

Revisions to DUHS Sample Consent Template

The DUHS Sample Consent Form Template has been revised:  https://irb.duhs.duke.edu/forms/duhs-sample-consent.  The only change was the removal of the old Female and Male Contraceptive language.  Investigators and study teams are now directed to the IRB web site where the new Contraception Standard Language is posted:  https://irb.duhs.duke.edu/standard-language/english-standard-language.  Please direct any questions regarding appropriate Contraception Standard Language for your protocol to Dr. Evan Myers:  evan.myers@duke.edu.

 

UPDATE: NOW AVAILABLE to CRNCs New Reporting Tool within Maestro Care: Slicer Dicer

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 NOW 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:

Slicer Dicer from Maestro Care Search Box

Here are access dependent links to useful SlicerDicer instructions

In addition, DOCR will host SlicerDicer office hours on Thursdays at 1:00 PM.  Attend in person, (meeting locations vary – see below) or join via WebEx using this link:  Join WebEx Meeting

  • Thursday, August 22, 1:00 PM – 2:00 PM – DOCR conference Room 1022 (Erwin Square 10th floor)
  • Thursday, August 29, 1:00 PM – 2:00 PM - DOCR conference Room 1022 (Erwin Square 10th floor)
  • Thursday, September 5, 1:00 PM – 2:00 PM - DOCR conference Room 1022 (Erwin Square 10th floor)
  • Thursday, September 12, 1:00 PM – 2:00 PM - DOCR conference Room 1022 (Erwin Square 10th floor)
  • 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)

 

Email Impersonation Fraud (Update)

The IT Security Office has seen a recent increase in reports of email scams where attackers impersonate Duke faculty and staff, asking other employees to purchase gift cards or make wire transfers.

These emails usually appear to come from staff members in management positions and follow the same general format:

The attacker registers an email address with an external email provider (such as Gmail) that appears as if it may be a personal email account for the person being impersonated.
Using publicly available information to determine targets, the attacker sends a message to users they suspect may work with the person they're impersonating. These messages are usually simple in nature and ask a question such as "Are you available?" or "May I ask a favor of you?"
If the user responds to the message, the attacker will respond to begin the fraud. Typically, this will lead to them asking for money to be transferred or for gift cards to be purchased.

Any email message from a Duke employee not originating from a duke.edu email address should be treated with suspicion. As always, any suspicious message can be reported to security@duke.edu for evaluation.

https://security.duke.edu/node/341

 

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.

 

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

Save the Date: Community of Scholars (CoS) Conversations

The Community of Scholars (CoS) Conversations series serves to connect scholars and mentors with resources and with each other.  See below for details on an upcoming event: 

Tuesday, Oct 29, 2019

4:00 - 6:00 PM

Duke School of Nursing Atrium

“Getting the Most Out of Your Data”

Advice and Insights from Data Science Experts and Experienced Mentors:

Maximize Your Research Progress through Meaningful Approaches to Your Data

 

Featuring:

L. Ebony Boulware, MD, MPH, Professor and Chief, Division of General Internal Medicine in the Department of Medicine, Director, Clinical and Translational Science Institute (CTSI), Associate Vice Chancellor for Translational Research, Vice Dean for Translational Science, Duke University School of Medicine

Keynote Speaker Robert M. Califf MD, MACC, Professor of Medicine, Duke University School of Medicine, Director, Duke Forge - Center for Health Data Science, Vice Chancellor for Health Data Science, Duke University

Q&A Session with accomplished and recognized mentors and data science experts

Reception and small group conversations with mentors, experts, and other scholars

Visit https://ctsi.duke.edu/cos-conversations to find out more!


iRIS/OnCore Updates

 

Accessing iRIS Support

As of August 12th, 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 Health IRB team).  The help button also takes you to additional resources, forms and tip sheets to help with your work.

With the launch of this Help feature, the bi-monthly iRIS/OnCore Office Hours are being discontinued after Monday, August 26, 2019.

 

Need Help with OnCore?

You can now email OnCore@duke.edu directly to create a Service Now ticket.  If you want one-on-one assistance or training for your team, contact Kristy Astin or Susan Natoli.

With the launch of this Help feature, the bi-monthly iRIS/OnCore Office Hours are being discontinued after Monday, August 26th from 11 AM to noon in DMP.2W91.  Stop by our final session for in-person assistance with iRIS/OnCore and receive a special treat!

 

OnCore Reports: Subject Consent Detail - by Protocol

Did you know there is a new question on the IRB progress report: “If applicable, how many subjects did you verbally consent for pre-scheduling?”

There is an OnCore report that can help you answer that.  The Subject Consent Detail – by Protocol report lists all the consents associated with participants on the study.    

You can find it under the Subject Visits section.

 

New iRIS Tip Sheet Available

A new iRIS Tip Sheet How to Revise Consents & Protocol Documents during Modification Rounds is now available on the iRIS Support page on the DOCR website.  This tip sheet provides detailed steps with screen shots for revising a consent or other protocol document during modification rounds. 


DOCR News

 

Research Professionals Network: Overview of the Clinical Quality Management Program

Thursday August 22, 2019 at 1:00 in Trent Semans Great Hall

Overview of the Clinical Quality Management Program

The Clinical Quality Management Program (CQMP) was established to develop and implement a comprehensive, standardized clinical research monitoring program for the Clinical Research Units (CRUs) and Oversight Organizations at Duke.

The CQMP launched in July 2018 with pilot training and completed the final rollout in May 2019. In this presentation, Geeta Swamy, Sharikia Burt and John Nocero will present a high-level overview of the Program and discuss its fundamental elements, including the Clinical Quality Management Plans Policy, Quality Management Review Tools, Quality Management Reviewer Training and Quality Management Reporting.

Light refreshments will be provided. Please use this link to register.

Learn more about the Research Professionals Network.

 


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.


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.