Duke Clinical Research Update June 17 2020

Wednesday, June 17, 2020
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SUPPORT OFFICE HOURS

REDCap Office Hours

 

Email redcap-docr@duke.edu to schedule a virtual session at one of the times indicated below.

Tuesdays 10 AM, virtual sessions
Wednesdays 10 AM, virtual sessions

Thursdays 2 PM, virtual sessions

Fridays 10 AM, virtual sessions

 

SlicerDicer Office Hours

Thursdays, 1 PM, via WebEx

 

PACE Office Hours

Every other Tuesday, 1 PM, via WebEx.  Click for information.

 

RESEARCH COMMUNITY NEWS

 

Phase II Clinical Research Reopening

The following announcement was sent to the Clinical Research Community on June 12th regarding Phase II Clinical Research reopening:

We are pleased to convey that after careful monitoring of state, local, and staff related COVID-19 cases and supply chains for PPE and disinfectant, we will proceed with Phase 2 clinical research activity on Duke premises as scheduled on Monday, June 15. We are appreciative for the careful precautions that our clinical research community has taken during Phase 1 and by your diligence in adhering to the masking, distancing, training, and data gathering requirements that we asked of you in preparation for Phase 2.  Please note that conditions will continue to be monitored carefully, and we will notify the clinical research community of any changes to the current plans.

As we enter Phase 2 of restarting our paused study activities, we would like to share a few key points and reminders.

  • Studies that meet the requirements for Phase 2 must be approved by the CRU and included in their approved Phase 2 plan prior to resuming any paused on-site activity. Phase 2 plans from each CRU are discussed and approved by Vice Dean Naggie with consideration of required safety resources and space utilization. Faculty and staff should not return on site to begin these activities without prior approval regardless of Tier or study characteristics.
  • Staff approved to work on site and continue or resume study activities will receive an approval letter from the Vice Dean for Clinical Research notifying them when they have been approved to be on site. This letter indicates that they have been designated by their CRU as having critical on-site functions for the studies that have been approved to continue or resume during Phase 2 and have completed their requirements. If you were planning to conduct on-site study activities and have not received this letter, you should continue working remotely until you receive notice.  Please contact docr.help@dm.duke.edu with any questions or if you believe that you should have received a notification.

Before approval to return on site there are three required steps for on-site staff. 

  • Density survey

Duke University, Duke School of Medicine, and DUHS are working very carefully to manage and understand the impact of additional personnel and research participants on-site.  The health and well-being of employees and the community remain our primary concern. Prior to approval to return, staff will receive a REDCap link to a density survey to assess the hours and spaces being used by returning and present staff. Staff who are already working on site will also be required to complete this survey.  Individual survey links will be sent out by DOCR to staff indicated by their CRU. If you have not received this and believe that you should have, please contact your ARPM or RPM. 

 

  • EOHW Daily Screening

Because the density of employees on-site is increasing, Duke Employee Occupational Health and Wellness is conducting a daily symptom screening for employees actively working on Duke premises.  This survey has already been rolled out to laboratory researchers in the School of Medicine and clinical and other researchers who are actively working on-premises across Duke.

On premises and staff returning for Phase 2 will receive a survey link from EOHW to register for their daily screening log. If you believe that you should have received this survey and did not, please contact your ARPM or RPM. 

  • Complete your profile and follow instructions as given by EOHW.
  • Submit a daily screening survey prior to leaving for work in the morning on the days when you will work on-site. 
  • If you are flagged by EOHW, do not come in to work that day.  You will be provided with further instructions by EOHW.
  • Note this does not replace the need for the in-person screening being conducted at the hospital and clinic entrances or the practices of masking and physical distancing. 

 

  • Online Training On-Premises Clinical Research Social Distancing and COVID Infection Prevention Training - DOCR (00147860)

This brief online training describes the phased return process for Clinical Research and guiding principles.

 

This phased plan has been discussed and developed in collaboration with CRU leadership as well as Duke University and School of Medicine leadership. 

For more information, visit the DOCR COVID-19 Resources Page.

In particular:

 

COVID-19 Data Science Seminars

 

This image is the COVID-19 Data Science Seminars Logo

Please join us for an 8-week series on data science methods with direct applications to the COVID-19 pandemic. Learn from Duke experts about the state-of-the-art in these 1-hour virtual sessions.

 

Tuesday, June 30 from 4–5 PM

Matthew Hirschey, Key elements of the analytical toolbox for understanding COVID-related data

Register at https://training.oit.duke.edu/enroll/common/show/21/175077

 

Tuesday, July 7 from 4–5 PM

David Carlson, Natural Language Processing and understanding the evolving COVID literature

Register at https://training.oit.duke.edu/enroll/common/show/21/175082

 

Tuesday, July 14 from 4–5 PM

Ricardo Henao, Molecular methodology connected to COVID data

Register at https://training.oit.duke.edu/enroll/common/show/21/175076

 

Tuesday, July 21 from 4–5 PM

Larry Carin, Simple introduction to deep learning

Register at https://training.oit.duke.edu/enroll/common/show/21/175075

 

Wednesday, July 22 from 4–5 PM

Matthew Kenney, Introduction to PyTorch computational platform for deep learning

Register at https://training.oit.duke.edu/enroll/common/show/21/175078

 

Thursday, July 23 from 4–5 PM;

Tim Dunn, PyTorch for image analysis with deep learning

Register at https://training.oit.duke.edu/enroll/common/show/21/175079

 

Tuesday, July 28 from 4–5 PM

Rachel Draelos, Analysis of chest CT imaging data and connection to COVID diagnosis

Register at https://training.oit.duke.edu/enroll/common/show/21/175080

 

Tuesday, August 4 from 4–5 PM

Ben Goldstein, Using data science to optimize scheduling elective procedures in the time of COVID

Register at https://training.oit.duke.edu/enroll/common/show/21/175073

 

Tuesday, August 11 from 4–5 PM

Fan Li, Causal inference for quantifying the efficacy of potential COVID medications and vaccines

Register at https://training.oit.duke.edu/enroll/common/show/21/175081

 

Tuesday, August 18 from 4–5 PM

Jessilyn Dunn, The opportunity for wearables for early COVID detection

Register at https://training.oit.duke.edu/enroll/common/show/21/175074

 

COVID-19 Grant Support SWAT Team

The School of Medicine has assembled a “SWAT Team” of individuals in various research support offices to facilitate proposal preparation and submission for investigators who seek funding for COVID-19 research.  During this time of higher proposal volume and when additional support may be needed, our goal is to supplement existing resources and support within the CRUs to respond to this demand.  Interested investigators should work through their unit grants administrator to seek the services of the SWAT Team – and we will maintain coordination with your unit to ensure we are providing synchronized services. 

 

Services can include all or some of the following (to be determined at time of intake):

  • Proposal development: timeline development/project management, document coordination, proofreading, figure development
  • Research Administration assistance: assistance in developing/reviewing ancillary application documentation (e.g. biosketches, subaward packages, etc.), supplemental Grant Administration

 

To engage the SWAT Team for these services, the grant manager/investigator may contact docr-grants@duke.edu to schedule a time to discuss the project and determine what assistance is needed.  A project manager will convene the best team based on the investigator’s needs. SWAT Team services are available immediately and are offered on a first-come, first-served basis.  Questions about this free service can be sent to docr-grants@duke.edu.

 

Lab and Leave Process for Clinical Research Labs Standard Operating Procedure

A new Standard Operating Procedure, Lab and Leave Process for Clinical Research Labs, has been posted to the DOCR website.

The purpose of this SOP is to outline the lab and leave process for clinical research labs in an effort to reduce the number of people and time spent at Duke University Hospital.  This SOP applies to clinical research specimens collected on adults, over the age of 18, that will be processed external to DUHS labs or stored by the study team.

The SOP also includes a link to a new Maestro Care Tip Sheet:  Lab and Leave Process for Clinical Research for detailed instructions for placing lab orders.

 

Idle Effort Reporting

The myRESEARCHhome (MRH) Idle Effort tool has recently been updated with May data. 

 

With this update, the process for how the project cards are generated and the fund code ranges that are generated has also been revised. 

 

The 391s/291 will no longer be generated. 

 

The ranges that will be generated include:

  • A0x, 20x-28x, 30x-38x
  • 293s/393s
  • 153s, 453

 

COVID-19 Resources Available on the DOCR Website

Several new COVID-19 Resources have been added to the DOCR website.

Resources include:

Resources for CRU Planning, recordings of recent Town Halls, as well as CRU Effort Sharing can also be found.

 

Clinical Research Training Program Accepting Applications

The program is now accepting applications for academic year 2020-2021. For a detailed description of the program, the course offerings, and a link to the online application, please visit the CRTP website at http://crtp.duke.edu.

 

This year CRTP is launching the Basic Science Research Track (BSRT), a customized curriculum designed for physician scientists and trainees leading to a Master of Health Sciences in Clinical Research Degree. 

 

The application deadline for priority review is May 15, 2020. Applications will be accepted through August 1, 2020.

 

 

IRIS/ONCORE UPDATES

 

Electronic Regulatory Binder Management System

The Electronic Regulatory Binder Management System overview scheduled for Research Wednesday has been postponed but that doesn’t mean you have to be!

 

  • If you would like to schedule an information session for your CRU or disease group, email susan.natoli@duke.edu
  • Anyone who will maintain an ebinder will need to take eReg Training for the Regulatory Coordinator.  It is available now in the LMS.
  • Include the binder fee in your industry budgets now. 

 

The fee structure is based on the funding source for the study.

  • Federal / Foundation funded      $0
  • Department funded                      $500
  • Industry funded                             $2500

 

 

DOCR NEWS

 

New Online IRB Overview Course

The in-person IRB Overview course has been moved online! If you need to complete this course in the LMS you can do so using the link below. The course includes a 1 hour video presentation and 15 minute IRB website review with staff from the DUHS IRB.

 

This class offers an overview of the DUHS IRB review process and requirements, federal regulations, and Duke policies pertaining to research involving human subjects. The course highlights tools available to study teams on the IRB website and provides strategies for working efficiently with the IRB.

 

Upon completion of this training, you will be able to:

  • Describe the DUHS IRB’s scope of oversight – what does and what does not require review by the DUHS IRB
  • Discuss the IRB review process
  • Describe reporting to the IRB
  • Recognize how to communicate with the IRB
  • Find the many tools available on the IRB website

 

Link to Course

 

Society for Clinical Research Sites

Members of the Duke Clinical Research Community are eligible for free membership in the Society for Clinical Research Sites.  Once you have registered with the site using your duke.edu email address, you will have access to:

 

 

 

RECRUITMENT INNOVATION CORNER

Health Literacy in Clinical Trials

 

What is health literacy, why do we need to know it, and who does it effect?

This is a graphic image of health information terms.

Health literacy is the extent a person has to “obtain, process, and understand basic health information and services needed to make appropriate health decisions1. We, as healthcare workers, have a distinct advantage when it comes to health literacy-we live it daily!  However, we must carefully consider the needs of our community, our patients, and our research participants when developing material we are asking them to comprehend and use to make decisions. 

 

Not everyone will understand “We are conducting a double blind, placebo controlled RCT study to determine the efficacy of drug X in disease Y with genetic mutations A, B, and C.”  Instead, consider explaining that sentence in a way that makes sense for someone who doesn’t work in research, such as “We are doing a study to understand how well drug X works in disease Y. In this study, you will be randomized (as in flipping a coin) to get the study drug or a placebo (a harmless sugar pill).”

 

Consider this list of health literacy principles in clinical research:

  • Communications should be clear and easy to understand.
  • Clear communication is necessary throughout the entire clinical research life cycle.
  • Research communications should be developed by partnering with the intended audience(s).
  • Cultural respect is an integral part of communicating appropriately about clinical research.
  • Research materials should integrate health literacy practices, including plain language, numeracy, clear design techniques, and cultural considerations.
  • Research materials for participants should be evaluated to ensure the intended audience(s) can understand the information.
  • In-person communication with the intended audience(s) should encourage dialogue and confirm understanding.
  • All clinical research stakeholders should support the development and implementation of organizational policies that integrate health literacy into clinical research.
  • Integration of health literacy into clinical research requires proactive planning to develop, test, modify, and confirm understanding of clinical research communications.

This is a line drawing depicting understanding versus not understanding information.

As always, please Contact us for any of your research needs!  We are happy to help researchers learn this important skill and give you resources to help refine it.  We can help you develop engaging eConsents, MyChart messages, websites, engagement letters, research notices, and more! 

 

For more information and resources to support the use of principles of health literacy in clinical research communication, visit: https://mrctcenter.org/health-literacy/

 

1)U.S. Department of Health and Human Services. 2000. Healthy People 2010. Washington, DC: U.S. Government Printing Office. Originally developed for Ratzan SC, Parker RM. 2000. Introduction. In National Library of Medicine Current Bibliographies in Medicine: Health Literacy. Selden CR, Zorn M, Ratzan SC, Parker RM, Editors. NLM Pub. No. CBM 2000-1. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services.

 

 

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.

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

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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