Clinical Research Update - August 2018

By Duke Office of Clinical Research (DOCR)

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


OnCore Community News

 

OnCore Tips, Tricks, and Did You Know?

Visit this link for more information


iRIS Community News

 
Responding to Email Correspondence within the iRIS System

When you receive an email correspondence that comes out of the new iRIS system there are a few important things to remember when replying in order for the correspondence to be logged in the iRIS System:

  • Do not change the Subject Line.
  • Use *only* Reply All.  Do not use Reply.
  • Do not use Forward. 

If you change the subject line or forward the email, the response will not be captured in the iRIS system and will not become a part of the record for that study. 

 

Uploading Revised Documents in iRIS

The IRB requests that study teams upload only a tracked version of an amended document (such as consent forms, phone scripts and advertisements) in iRIS.  Clean versions should not be uploaded. 

Amended documents should replace the original document that was approved.  To do this, create a revision of the approved document, check it out, track the changes that you are making with the amendment, and check back in the tracked document.  Remember to save changes.  Only upload a tracked version of the document. 

The tip theet for How to Revise an Existing Study Document can be found on the DOCR web site.

 

Finding Approved Consent Forms

Question:  With the new iRIS System, where should I look to find approved consent forms?

  • If you have an approval in iRIS for a continuing review or an amendment affecting the consent form, please check in iRIS for the latest approved consent form(s). 
  • If you have had no amendment changes or a continuing review in iRIS since the system went live on May 21, look in the Legacy eIRB for your approved consent form(s).

The approved consent form will have a different watermark in the footer when approved in iRIS.

Once document migration is complete, all consent forms will be in iRIS.  Until that process is finalized, you will potentially need to check both systems.  Please be sure you are always downloading and using the most current approved consent form.

 

iRIS Training and Quick Tips

The iRIS Training and Quick Tips section of the DUHS IRB website has been updated.  Be sure to stop by for up to date information regarding iRIS Training as well as Quick Tips on Migration Amendments, Submitting an Application, Amendment Tips, and more!

 


Research Community News

 

School of Medicine Research Strategic Plan

Dean Klotman and the School of Medicine recently engaged many of our faculty and staff in a strategic planning initiative to guide the future of our research mission.  The resulting research plan, Leading the Next Generation of Discovery and Impact, is an important extension of the school-wide 2016 strategic plan and provides a focus and clarity on our research priorities. The plan is far reaching and identifies priorities across many domains while still enabling dedicated efforts to advance our research agenda. 

The plan can be found on the School of Medicine website under the About Us or Research tabs. https://medschool.duke.edu/about-us

Read the complete plan.

 

Changes to Notice of Privacy Policy (NPP)

In 2018, Duke Health will implement changes to the Notice of Privacy Policy. Duke Health is adding or clarifying language in the policy about the use of patient information for medical care decision-making and clinical research. The changes include:

  • Clarified language about using a patient’s information for clinical contacts
  • Added language about using patient information for Health Information Exchanges (HIEs), including patient opt-out instructions
  • Added language clarify using patient information for research
  • Added language about contacting patients for research, including patient opt-out instructions.

The research changes are being made in preparation for the development and implementation of Duke’s new research participant engagement policy, anticipated in fall 2018. This policy is intended to expand engagement and communication about clinical trial information and facilitate the recruitment of research participants. Policy details and required training will be provided by the Duke IRB and Office of Clinical Research. For more information, please contact docr.help@duke.edu.

 

Get Data@Duke and Vivli/Altmetrics Partnership

In an effort to enable Duke Investigators access to a broad array of datasets and the promotion of open sciences and data sharing, Duke University has partnered with Vivli to engage a New Era of Open Science.  For information regarding this partnership and what it means for Duke Investigators see the following:

 

Duke ClinCard Pricing Changes

Since the initial implementation of the Duke ClinCard system in August 2015, the vendor (Greenphire) has continued to evaluate opportunities for enhancements to the tool.  As you are aware, the vendor recently upgraded the system and incorporated a number of enhancements.  Although there were a few issues with the upgrade, the vendor has resolved the open items and the overall enhancements will prove to be very effective. 

In the efforts to continue to provide enhancements and to remain competitive in this industry, the vendor has re-evaluated the pricing structure and introduced changes in the load fees and card costs effective August 1, 2018.  As you may recall, Duke University had a pricing structure for cards and load fees that was unparalleled by other clients.  Fortunately, our partner in Administrative Systems Management did another outstanding job negotiating the pricing to keep the fees at the lowest possible rate. 

The new costs are included in the table below.  Please include the new fees as you have discussions with new federal and/or industry partners.  Also, if appropriate, please update your current agreements to reflect these changes.   With regard to the card costs, we have ordered a supply at the $3.50/card rate which should allow Employee Travel & Reimbursement (ET&R) team to leverage this fee for the next several months.  We do not anticipate charging the $3.97 until this Fall. 

Fiscal Year Cost Per Load Per Card Cost (Custom)
Current (FY18) $1.00 $3.50
FY19 (8/1/18 – 6/30/19) $1.05 $3.97
FY20 (7/1/19 – 6/30/20) $1.15 $4.43
FY21 (7/1/20 – going forward) $1.15 $4.90

If you have any questions, please review with your Research or Finance Practice Manager, Business Manager or email School of Medicine Finance Office at SOMFClinicalResearch@duke.edu.  In the event there are additional questions, the ClinCard Site Administrator or Business Manager can contact ET&R by email at employeetravel@duke.edu or by phone at 668-3877.

 

Duke’s BioRepository & Precision Pathology Center (BRPC) Featured on Mendelspod Podcast

Biospecimen quality is critical to the success of research.  Duke’s BioRepository & Precision Pathology Center (BRPC) is a College of American Pathologists (CAP) accredited biorepository (shared resource) directed by Shannon McCall, MD.  BRPC is in the business of getting high-quality human biospecimens into the hands of Duke researchers and their collaborators.  Dr. McCall was recently interviewed on Mendelspod Podcast.  Click to listen to the feature which highlights Duke Biobanking:

https://mendelspod.com/podcasts/should-biobanking-come-under-clia-shannon-mccall-duke/ 

 

Updated Imaging Rates for the Center for Advanced Magnetic Resonance Development (CAMRD)

CAMRD recently contacted study teams to inform them of imaging rate increases recently approved by the School of Medicine.  For those utilizing CAMRD for research imaging, your imaging rate(s) may be impacted.  To allow study teams adequate time to adjust their budgets accordingly, the new rate(s) will not go into effect until October 1, 2018.  Studies that have been reviewed and approved (provisional or full approval) by the CAMRD Scientific Committee within the past 3 months should already have been notified about the new rates.  

Please feel free to contact Gemini Janas with questions, concerns or for further details. 

Email: gemini.janas@duke.edu  

Office: 919.684.7403

We appreciate your understanding.

 
Requesting Maestro Care Access or Changing Access for an Employee

To request Maestro Care access for new users OR any change to access for current employees, please have your Research Practice Manager, Assistant Research Practice Manager, or Research Program Leader submit a request via Service Now or by calling the Research Support Help Desk at 919-684-2243 option 4.  Note that the Research Practice Manager, Assistant Research Practice Manager, or Research Program Leader need to be the person submitting the Service Now ticket in order for the request to be processed.   Also, be sure to complete all required training based upon your role prior to submission of the Service Now ticket request.

 

Compliance Training Requirements for New Faculty and Trainees

Welcome to new Faculty and Trainees!

Although it doesn't feel like fall, we are starting to see new faces in our research areas.  We need to help them get the training they need to be successful researchers at Duke.  You can help them get up to speed with Compliance Training, CITI, RCR and GCP, and even iRIS and OnCore training.  Review your department's or center's Scientific Culture and Accountability Plan (SCAP) with them. 

 

Duke/Stanford CEC Summit 2018

An exciting new clinical events classification and safety meeting is taking place September 26-27 in Chicago, coordinated by the Duke Clinical Research Institute and the Stanford Center for Clinical Research.  Designed for academic and industry thought leaders involved in adjudication, the two-day symposium promises to deliver provocative and challenging discussions on trends in the industry and the development of CEC/safety best practices, strategies, and quality standards.  For additional information and to register:  https://dcri.org/our-work/trial-support-services/cec/cec-summit/

 

Two Funding Opportunities Available from CTSI

Duke CTSA KL2 Program

A mentored research career development program for junior faculty

The Duke CTSA KL2 program provides training and research opportunities for junior investigators that will equip them to:

  • Participate in and ultimately lead transdisciplinary research teams
  • Facilitate advancement of discoveries to their next translational phase
  • Represent a more diverse workforce to meet evolving translational science priorities
  • Leverage partnerships locally, regionally, and nationally to enhance the impact of their discoveries

 

These goals will be achieved through individual and group support for scholars and by working with Duke’s CTSA resources and services. Each year, three Duke CTSA KL2 Scholars will be awarded 75% total protected effort for 3 years, up to $20,000/year for research expenses, and up to $2,500/year for travel to professional meetings.

Learn more: ctsi.duke.edu/KL2

Application Deadline: November 30, 2018

 

Carolinas Collaborative

This multi-site CTSA Translational Research Pilot Program is offering the opportunity for investigators to use electronic health records from multiple health systems in clinical research.

The Carolinas Collaborative is a data resource that harmonizes the electronic health record data across local CTSA institutions (Duke University, the Medical University of South Carolina, the University of North Carolina at Chapel Hill‐RTI partnership, and Wake Forest University) to expedite clinical research. The proposed pilot work should collect preliminary data to lead to a competitive proposal submitted to an external funding agency (NIH, AHRQ, PCORI, etc.) within one year from onset of funding.

Learn more: ctsi.duke.edu/funding/carolinas-collaborative

Submission Deadline: August 15, 2018

 

Translating Duke Health Cardiovascular Disease Initiative:  Request for Proposals

The Translating Duke Health Cardiovascular Disease Initiative is pleased to announce a call for proposals to identify areas for investment that will accelerate research in the area of Cardiovascular Resistance, Resilience and Rejuvenation.  Our goal is to build on existing Duke expertise and resources to create a small number of research ‘force multipliers’ or platforms for multidisciplinary work addressing important areas of unmet needs.  We are looking for proposals across the continuum of bench to bedside to population health. Successful ideas will greatly enhance our environment for discovery and will have potential for both scientific and public health impact.

Deadline: Proposals must be received by 5 PM EST, August 1, 2018

Full details on this initiative can be found on the School of Medicine website.

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

 

Request for Proposals for School of Medicine Interdisciplinary Colloquia 2018

The School of Medicine is accepting applications for its 8th annual RFP to provide support for interdisciplinary colloquia that bring together basic, translational, clinical and data science faculty members with common interests in a biomedical problem or area.  Interested applicants are encouraged to read about colloquia that have been funded in previous years.

Funding

Awards of up to $5,000 will be provided to support each successful proposal.  Funds can be used to cover food, meeting venues, external speakers or other meeting costs.  Previously funded proposals will be considered for a one time renewal.  Applicants for a renewal must articulate the value added by their colloquia over the past year(s).

Eligibility and Requirements

Proposals must be submitted by teams representing two or more departments, institutes or centers. Applicants for funds must include faculty members with primary appointments in a School of Medicine department. Meetings may have any format (e.g., small monthly dinner meetings, larger quarterly meetings, other approaches), but should be designed to bring together faculty members with diverse perspectives. Preference will be given to proposals that articulate a plan to sustain interactions and/or prepare joint grant applications after the initial colloquium supported by the School of Medicine.

Process

Applications/renewals should be submitted online using the link below. All submissions must be received on or before 11:59 PM, August 9, 2018. 

  • To apply visit http://bit.ly/myresearchproposal, click on “Create New User” (or log in if you already have an account). 
  • Proposals must be submitted under the Principal Investigator’s name.  
  • Enter Access Code ‘SOM’ then select the “Interdisciplinary Colloquia 2018” application.

For all system or password questions, contact Anita Grissom at myresearchproposal@duke.edu.  For other questions, contact Lauren Binanay at lauren.binanay@duke.edu.

 

Save the Date:  Basic Science Day

Basic Science Day, a celebration of Basic Science Research at the Duke University School of Medicine, will be held on Wednesday, September 12, 2018, 9 AM – 5 PM in the Trent Semans Center Great Hall.  This year’s event will feature James A. Spudich, PhD, speaking on “The Myosin Mesa and Hypertrophic Cardiomyopathy:  Mutations to Mechanisms to Therapies”.  For additional information and to register:  https://medschool.duke.edu/research/basic-science-research/basic-science-day

 

Duke Digital Health Week

The inaugural Duke Digital Health Week will be the crossroads at which health, tech, business and the social sciences at Duke meet. Mobile technology and wearables are empowering patients and caregivers with data, and with the introduction of artificial intelligence, virtual reality and telemedicine into the clinician's tool bag, the way we experience healthcare is rapidly changing. As the use of digital health technologies expands, we ask, what's in store for the future of health?

The Duke Mobile App Gateway is bringing together experts from Duke Health and Duke University together with patients, families, students, and the curious. We want to include everyone with an interest in the future of healthcare in the conversation; we'll share ideas, new findings, best practices, tools, and raise questions. Come imagine the future of Digital Health.

When: Monday, September 17th - Thursday, September 20th

Where: Various locations around Duke

For more information and registration: bit.ly/DukeDHWeek2018

 

Save the Date:  Keeping the Heart Young:  The Science of Cardiovascular Resistance, Resilience and Rejuvenation

Translating Duke Health will be hosting this daylong event Saturday, October 6, 2018, 8 AM – 3:30 PM.  The event will bring together national experts in Cardiovascular Disease to address the science of keeping the heart young.  For more information and to register, visit the School of Medicine website.

 

Save the Date:  2018 Clinical Research Appreciation for Faculty and Staff

The 2018 Clinical Research Appreciation for Faculty and Staff, sponsored by the Duke Office of Clinical Research, is scheduled for Tuesday, October 16th, 11:00 AM – 1:30 PM, Trent Semans Center Great Hall.  This drop-in event is open to all faculty and staff involved in Clinical Research at Duke and will feature informational tables from Clinical Research Administrative groups and Partners as well as food, music, dancing, and door prizes.

 

Save the Date:  Technologies and Innovations in Human Immunology

Translating Duke Health Immunology & Transplant Initiative will be hosting a half day event Friday, November 2, 2018, 8:00 AM – Noon.  The event will acquaint the Duke research community with ongoing intramural research efforts in the field of human immunology with the goal of bringing together new collaborations and identifying opportunities for future projects.  For more information and to register: https://duke.qualtrics.com/jfe/form/SV_5hUsrABzCmArMCp.

 


DOCR News

 

DOCR Annual Satisfaction Survey

We need your feedback! 

In our continuing efforts to refine and improve our service to the research community, we would like to receive your feedback in our annual DOCR Satisfaction Survey.  You can access the survey here and all responses will be anonymous (you will be given the option to provide your name).  Respondents also have the opportunity to be entered into a drawing to win a $100 Duke University Bookstore Gift Card (while still maintaining anonymity of individual survey responses)! 

If you have any questions or concerns, please direct them to DOCR.Help@dm.duke.edu.

 

Study Initiation Tracker (SIT) to be Retired

With the implementation of OnCore, the Study Initiation Tracker (SIT) application is being retired.  Data that was historically tracked in the SIT will now be tracked in OnCore.  Users who click on the SIT URL will be redirected to the OnCore website.  Users can check the status of their protocol within the OnCore system.

 

REDCap Day

The Duke Office of Clinical Research invites you to join us for REDCap Day on September 26th from 10 AM – 4 PM in the Trent Semans Center Great Hall.

This is a chance to learn more about REDCap and what it can do for your research. The keynote speaker will be Rob Taylor, the lead REDCap developer from Vanderbilt, to talk about what is new and next for REDCap.

All skill levels invited.

Please register here to let us know you plan to attend. We look forward to seeing you there!

 

Research Professionals Network:  Work/Life Integration Workshop

Thursday, August 9 1:00-2:00pm in Trent Semans Great Hall

We all have responsibilities and passions outside of work and often face challenges in meeting our personal and professional goals when the different areas of our life are not well integrated. Meeting facilitators, Stephanie Freel, PhD, PMP and Beth Perry, RN, CCRP, will discuss chal­lenges they have faced and will lead the group in a series of exercises from the “Total  Leader­ship” program that assess the goals you have in each domain of your life, and help identify con­crete actions you can take that will better align these goals.

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

 


Did You Know?

 

REDCap Custom Templates

DOCR can create a custom REDCap template for your department.  If there are specific forms/questions/roles that are always used in projects for a specific CRU/Department, DOCR can create a template so every project requested already has the specific information needed.  Time does not need to be spent on copying or uploading a Data Dictionary.

Contact us at redcap-docr@duke.edu and we will work with your team to create a custom template and instructions on how to request that each time a new project is needed.

 

REDCap Updated eConsent Instructions

REDCap eConsent instructions have been updated.  Study Teams are now able to build eConsent into their project without the help of DOCR and there is no longer a fee.  All eConsent functionality can be accomplished with External Modules or native built-in capabilities in the survey settings.

Please click here for updated instructions.

 


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

 

  • Roy McDonald, MPH, CHRC, CCRP has been named Ophthalmology Clinical Research Practice Manager.Roy joins Ophthalmology from the University of Alabama at Birmingham where he has worked in the academic and research environment there since 2005.During this time, he had broad exposure to clinical research and spent time in the Clinical Departments of Radiology, Hematology/Oncology, Genetics and Ophthalmology.He holds dual Bachelors degrees from Tulane in Chemistry and in Cell and Molecular Biology, a Masters degree in Public Health from UAB, and is currently completing his PhD in Health Services Administration.His official start date will be August 15, 2018.
  • The Radiology CRU welcomes Mark Mayo and Pamela Bonner as Clinical Research Coordinators in our CRU.Welcome to the team!
  • The Radiology CRU welcomes Robbie Williamson as a Clinical Research Specialist, Sr. in our CRU.Welcome to the team!

 


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 DOCR Clinical Research Update newsletter, please contact the DOCR at docr.help@dm.duke.edu.

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