Duke Clinical Research Update May 20 2020

Wednesday, May 20, 2020
This image is the Duke Clinical Research Update Banner

 

 

 

 

 

 

 

 

 

 

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

 

Projected Dates and Guidance for the Phased Return to Clinical Research Activities

The following memo was sent from Adrian Hernandez, MD, Vice Dean for Clinical Research, School of Medicine and Susanna Naggie, MD, Associate Dean for Clinical Research Initiatives and Regulatory Affairs, School of Medicine, to Duke University School of Medicine Clinical Research Faculty and Staff on May 19, 2020.

 

Duke University, Duke Health and Duke University School of Medicine (SOM) are planning for or have entered the first phase of returning to the workplace during the COVID-19 pandemic. Duke’s plans will align with Durham and North Carolina phased reopening models as well as the federal government and other federal organizations.

 

As the SOM begins our phased return to clinical research activities, we must ensure alignment with Duke University, DUHS, and PDC policies for phased reopening. In addition, it is critical to emphasize that as we return, we will not return to activities as we knew them pre-COVID. Instead, we will return to activities under core Guiding Principles including maintaining recommended social distancing, masking and hand hygiene practices in the workplace, symptom monitoring,  teleworking for staff and remote research visits for participants whenever possible, minimizing the number of staff doing in-person activities, and minimizing the amount of time spent in the presence of others including participants. While we are optimistic that the plan we have developed will allow us to sustain our path forward, we have incorporated into our modeling the ability to rapidly return to our current, baseline level should conditions necessitate this. 

 

Our current projected dates for returning to clinical research activities at the workplace and the classifications of studies assigned to the different phases of reopening are provided below. Transition from one phase to the next is contingent on stability of local and statewide key COVID-19 metrics and will be communicated over time.

 

Phase 1              June 1              Externally funded, Tier 2 in-person study activities that occur on

Duke Health premises and can occur concomitantly with clinical care visit; continue current virtual/remote activities

 

Phase 2              June 15            Externally funded, Tier 3 in-person study activities that occur on

Duke Health premises and can occur concomitantly with clinical care visit; continue current virtual/remote activities

 

Phase 3              July 15              Other Tier 2 and Tier 3 studies not opened in June, including

                                          community-based research

 

Definitions of Essential and for each Tier of Clinical Research can be found here

 

We are working closely with CRU leadership to develop materials that will aid research teams in developing Return to Clinical Research plans.  We have requested that CRUs provide us with information on each study proposed for return so that we can ensure appropriate phasing of our reopening.  We appreciate everyone’s hard work as we aim to reopen clinical research at the workplace activities safely.

 

We will host a Town Hall on Wednesday, May 20th from 4-5 PM. Join by webex

https://dukemed.webex.com/dukemed/j.php?MTID=m594a835e70930c4bdf1f1efdd1fd5c09

Meeting number (access code): 

473 842 837

Meeting password: 

P8EpBS4bcn4

 

 

Or join by phone: 1-650-479-3207 Call-in toll number (US/Canada)  

 

Please feel free to contact susanna.naggie@duke.edu for Clinical Research related questions.

 

Clinical Research Town Hall:  May 20, Dr. Susanna Naggie

Join Dr. Susanna Naggie, MD, as she presents this Clinical Research Town Hall.  This important discussion will include updates on COVID-19 Research at Duke and plans for the next phase in resuming in-person clinical research.

 

Topics to be covered include:

Clinical Research Updates
COVID study updates
Discussion of phased plan for resumption of in-person clinical research activities

 

Wednesday, May 20, 4:00 PM – 5:00 PM

 

 

Join this session via WebEx:

When it's time, join your Webex meeting here.

 

 

Meeting number (access code):

473 842 837

Meeting password:

P8EpBS4bcn4

 

 

Link:

https://dukemed.webex.com/dukemed/j.php?MTID=m594a835e70930c4bdf1f1efdd1fd5c09

 

Join by phone 
Tap to call in from a mobile device (attendees only) 
1-650-479-3207 Call-in toll number (US/Canada) 

 

Notice to Researchers Conducting Coronavirus-based Research or Activities

The FBI has issued a warning that U.S. health care and research institutions working on COVID-19 response are being targeted by Chinese attackers seeking to obtain intellectual property and data related to vaccines, treatments, and testing.  The joint Duke IT Security Offices will present on risks to coronavirus-based research from foreign nation states and will show how an attack would be crafted against Duke research.  They will highlight steps that you can take to reduce the risk or impact of an attack.

 

Zoom Webinar: Thursday, May 21 – 9 - 9:30AM

https://duke.zoom.us/j/92289560012

 

This webinar will be recorded and posted. 

Please feel free to share this announcement with others within Duke.

 

IRB Meeting Calendar for 2021

The DUHS IRB has posted its calendar for the 2021 regularly-scheduled convened board meetings:  https://irb.duhs.duke.edu/irb-review-process/irb-meetings

The image shows the IRB meeting schedule for 2021

 

Pediatric Risk Evaluation Prior to IRB Review

Beginning June 1, 2020, studies will no longer be routed for a separate pediatric risk evaluation prior to IRB review. 

 

New studies with pediatric patient populations have traditionally been routed to Dr. Robert Drucker in the Dept. of Pediatrics for an initial evaluation regarding the study’s pediatric risk.  The IRB, during expedited or convened review, then either confirmed that assessment or revised the risk assessment.  In accordance with federal regulations, the final determination of pediatric risk assessment is the responsibility of the IRB. 

 

To streamline the process and maximize efficiencies, the IRB will continue to evaluate pediatric risk level and make this final determination as required.  The initial assessment by Dr. Drucker, conducted prior to IRB review, will be discontinued.

 

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

 

When Transferring Data or Samples to External Entities or Persons

The IRB does not need signed copies of contracts/Material Transfer Agreements (MTAs)/Data Use Agreements (DUAs) to be uploaded in iRIS for transfers of data or samples.  Rather, the research summary in your IRB application should include language indicating the expected transfer, what data/specimens will be transferred, and entities/persons involved in the transfer. 

 

For example:

“The study team at Duke will transfer de-identified data to Johns Hopkins for external analysis once appropriate agreements between Duke and JHU have been fully executed.”

Likewise, study teams do not need to upload external vendor agreements or releases, particularly when sending de-identified samples for analysis.  Instead, include this sentence in your research summary in iRIS:

“No samples will be sent for external analysis until appropriate agreements between Duke and the vendor have been fully executed.”

 

Note the following exception:  the IRB reviewer may request a copy of an agreement as part of his/her review.

 

If you have any questions, please click here to check in with your IRB specialist.

 

 

Idle Effort Reporting for Sponsored Research

Over the past several weeks, Principal Investigators with responsibility for faculty, staff, and trainees on sponsored research codes have been asked to record “idle effort.”  This is how Duke is capturing the extent to which sponsored research productivity has been impacted due to COVID-19.   The term “idle effort” is used not to suggest that project staff are unproductive or not working at all, but to describe the planned project activities that cannot be carried out because access to needed facilities and resources is limited.  This reporting is anticipated to continue through early summer.

 

For details on reporting, we encourage research teams to reference the guidance documents, video tutorials, and other information found here.  https://research.duke.edu/covid-19-tracking-effort-PI

 

Faculty who are responsible for research codes should work with their departmental grants administrators if questions arise.  If there are additional complexities to be considered, please contact your ORA representative.

 

CTSI Website:  Training for Collaborations and Contributions in a Time of Crisis

Are you having to rethink how you conduct and/or contribute to research in this swiftly changing environment? Abundant training resources are available across Duke to facilitate that transition, but they can sometimes be difficult to track down across myriad websites and platforms. To aid in guiding investigators and research staff to essential educational tools needed to keep moving forward, the CTSI Workforce Development Core has pulled together this information page, with training resources listed both by topic and by research role. Check it out today!

 

Are You Curious about the Overlap of Health IT and Research?

The Regenstrief Institute of Indiana University is offering 3 online continuing education classes starting June 15, 2020, on the topics of quality improvement, public health IT, and terminology in health care and public health settings. All materials were originally created and funded by the Office of the National Coordinator for Health Information Technology (ONC) and are available on their website.

 

The classes are free of charge and will be held via Zoom once weekly through the end of August; a certificate of completion is available for participants who meet attendance requirements. For more information about class logistics and/or content, please email Amanda McMillan, staff director of the Duke CTSI Workforce Development Core.

 

Interested? Sign up at https://redcap.uits.iu.edu/surveys/?s=DLKAEECP4F. The training is open to all Duke faculty and staff, but please be sure to note on the registration form under item 4 (CTSA/Organization) that you are affiliated with the Duke CTSA.

 

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

 

OnCore Added as Option in RDSP

We have received multiple questions and requests to list OnCore in the RDSP.  As of last week, OnCore was added to the RDSP under Duke Health Internal section.

Just like Redcap and other approved Duke systems OnCore is now available for selection as a storage location in the RDSP.

This image shows the Duke OnCore selection box within OnCore

 

Protocol Status Workflow:  Changing from Suspended to Open to Accrual

 If your study is currently SUSPENDED in OnCore and you are ready to resume enrollment and “OPEN TO ACCRUAL”, be sure to select the OPEN button to make this change.  By selecting “OPEN” the SUSPENDED status will show on the summary tab in PC console and will also factor into reports and metrics as needed. 

If your study and/or enrollment was temporarily suspended DO NOT select “Undo Suspend.”  The undo suspend button should ONLY be selected if the suspended status was selected in ERROR.  

If the undo suspend button is selected, the suspend status does NOT appear in the protocol status summary.  Thus the suspension will not be included in any reports nor will it be factored into your enrollment metrics.   

This image shows the OnCore System PC Console changes from Suspended to Open to Accrual

 

A Rare Disease Field has been Added in OnCore

 

This image shows the Rare Disease field in the OnCore system.

A Yes/No question has been added to identify rare diseases in the latest release of OnCore.

  • Do not complete this field for studies in the Oncology Library.  The Cancer Protocol Committee will complete this field based on the NCI definitions for a rare disease.
  • For studies in the Non-Oncology Library, please confirm the disease is listed on the NIH site, https://rarediseases.info.nih.gov/diseases/browse-by-first-letter prior to selecting Yes.

 

 

DOCR NEWS

 

New Online Course Alert!  Adverse Events:  Identify, Document, Report

New to clinical research or need a refresher on Adverse Events? This new DOCR course is available in the LMS and takes about 30 minutes to complete.

 

The course is designed to help clinical research study teams understand adverse events and the processes surrounding them at Duke. The module addresses identifying adverse events for research studies, collecting and documenting data regarding adverse events, and reporting these events to different governing bodies.

 

The course provides guidance to help develop a baseline in the following WE-R clinical research competencies:

  • Safety and Ethics: Adverse Events
  • Safety and Ethics: Sponsor/Regulatory Reporting

 

Check out Adverse Events: Identify, Document, Report

 

Please note: This course, along with the fairly new required training on Prompt Reporting to the IRB replace the old LMS module Monitoring and Reporting Safety. If you have the Monitoring and Reporting Safety course listed in onboarding materials, please replace it with the link and title listed above.

 

Society for Clinical Research Sites Free Memberships Available

Did you know that the Society for Clinical Research Sites is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation?

 

As a member of the Duke Research Community, your free membership to the Society for Clinical Research Sites (SCRS) includes opportunities to obtain these contact hours.

 

To see upcoming opportunities for contact hours, follow these steps:

Go to:  https://myscrs.org/

  • Create your free SCRS account using the My Account link in the upper right hand corner
  • After creating your account, select the Learning Campus tab
  • Under Learning Campus click on Webinars

 

 

RECRUITMENT INNOVATION CORNER

Optimizing eConsent in REDCap

This image shows the REDCap logo

Due to the COVID-19 pandemic, many of you have had to quickly familiarize yourselves with eConsenting.  REDCap is widely used here at Duke for eConsent, though often our eConsent tends to be just as long, complex, full of medical jargon, and text heavy as our paper consents.

 

On average, people have time to read at most 28% of the words during a visit to a website, while 20% is more likely.1 Evidence demonstrates that people read even less when the text is on a screen than when it’s on paper. We tend to skip and skim in an F pattern when reading material on a digital screen, which can have implications for whether potential participants are actually absorbing the important information in your consent form.

 

Yet, often, your e-consent may be the first encounter a potential participant has with information about your study beyond a MyChart message or social media ad. The more engaging and informative you can make it, the easier you can make it to absorb the decision-supporting information you are trying to present, the more likely your potential participants are to make a truly informed decision to participate in your study.

 

Luckily, REDCap has created a centralized repository of curated external modules that can be downloaded and installed by a REDCap administrator.

 

External Modules are add-on packages of software that can extend REDCap's current functionality, as well as provide customizations and enhancements for REDCap's existing behavior and appearance.

This image shows a sample of a study advertisement

 

These modules can include:

  • Videos
  • Short clips of key procedures
  • Hover and Click allowing us to
    • Define text
    • Show pronunciations
    • Show images
    • Give links
    • And more!

 

To learn more about how your team can use these click here and contact the DOCR REDCap team at redcap-docr@duke.edu!

 

Contact the RIC for help with modifying your eConsent language to make it more lay-friendly, engaging, and easy to read.

 

1 Harald Weinreich, Hartmut Obendorf, Eelco Herder, and Matthias Mayer: "Not Quite the Average: An Empirical Study of Web Use," in the ACM Transactions on the Web, vol. 2, no. 1 (February 2008), article #5.

 

 

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 is available on the DOCR website under Available DOCR Trainings.

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

This image shows a building on Duke West Campus.

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