Duke Clinical Research Update November 18 2020

Wednesday, November 18, 2020

 

 

 

 

 

 

 

 

 

 

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, 2 PM, via WebEx

Click for SlicerDicer Tipsheets

 

PACE Office Hours

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

 

RESEARCH COMMUNITY NEWS

 

DUHS Updates to Team Member Screening

Across the health system, DUHS Leadership is making important updates to the team member screening process. We continue to monitor all of our processes and procedures, and we will implement changes as appropriate based on recommendations and guidelines provided by our infectious disease experts and the CDC. 

 

At many locations, including Duke South, we are transitioning our team member screening process to better utilize the Duke HealthCheck app and SymMon technology.

 

As these processes continue to be refined by DUHS Leadership, be sure to review communications from your entity about these changes and download the app today on your mobile device.

 

IT Security Office:  Annual Security Awareness Training

Recently, the Duke community has been notified through multiple channels that US healthcare systems are currently under attack from cybercriminal organizations.

 

As part of our ongoing efforts to keep Duke secure, the joint Duke IT Security offices have developed a short (approximately 10 minute) annual security awareness training in the Duke Learning Management System (https://lms.duhs.duke.edu/Saba/Web/Cloud)

 

Duke Health employees will be notified via email that they have been automatically enrolled in this required training beginning the week of November 16, 2020.  The email will contain a link to the LMS and the training can be found in the “MyLearning” tab

 

Duke University faculty, staff and students who wish to take the training can voluntarily self-register by logging into the LMS, searching “Annual Security Awareness Training” and selecting “register”. 

 

For any questions or comments, please email security@duke.edu.  Note – the links in this communication are safe and point to internal, Duke sites, but we encourage you to hover over them to see where they are taking you.

 

Our vigilance as an organization has never been more important. Thank you in advance for your heightened awareness and the steps you take to detect and report security incidents.

 

Report on Testing for Asymptomatic SARS-CoV-2 Infections on a College Campus

The following article appeared in the Morbidity and Mortality Weekly Report (MMWR) Early Release - Vol. 69, November 17, 2020:

 

Implementation of a Pooled Surveillance Testing Program for Asymptomatic SARS-CoV-2 Infections on a College Campus — Duke University, Durham, North Carolina, August 2–October 11, 2020

 

Article Summary:

What is already known about this topic?

SARS-CoV-2 can rapidly spread through university settings. Pooling specimens can enable large-scale testing while minimizing needed resources.

 

What is added by this report?

In fall 2020, Duke University’s COVID-19 prevention strategy included risk reduction behaviors, frequent testing using pooled SARS-CoV-2 polymerase chain reaction testing, and contact tracing. Among 10,265 students who received testing 68,913 times, 84 had positive results. One half of infections were asymptomatic, and some had high viral loads.

 

What are the implications for public health practice?

SARS-CoV-2 transmission was limited in this congregate setting by integration of prevention strategies that included identification of asymptomatic infections through frequent testing. Pooled testing reduced the need for resources while allowing high throughput with high sensitivity and rapid turnaround of results.

 

PDF of this report (link).

Maestro Care:  New COVID-19 Infection Status Banner in Storyboard

Beginning November 17, patient COVID-19 infection information began appearing in a banner in the patient’s Storyboard.  Maestro Care users with access that allows them to see patient infection information are able to see the banner.  Statuses in the banner include COVID-19 Positive, Suspected, and Recovered, among others.  Hovering over the banner reveals a pop-up containing details of the patient’s COVID-19 status.  For more detailed information, please review the COVID-19 Infection Status Banner in Storyboard document found here.

Screen shot of Maestro Care COVID-19 Infection Status Banner in Storyboard

 

CITI Modules Now Available in Spanish
Módulos CITI ahora disponibles en español

We are pleased to announce the following CITI modules are now available in Spanish for research teams at Duke and their community partners.  These Spanish modules are available thanks to an investment from the Center for Nursing Research who purchased these modules.

  • GCP Course for Clinical Trials Involving Investigational Medical Devices
  • GCP Course for Trials with Investigational Drugs (international/ICH focus)
  • Good Clinical Practice Course (US FDA focus)
  • Biomedical Researchers
  • Revised Common Rule
  • Social & Behavioral Educational Researchers (SBR)

To access these modules, users should log on to their CITI profile, click the Duke Health “View Courses” link on the middle of the homepage.

Screen Shot of CITI View Courses button selection

Towards the bottom of the next page, click the “Add a Course” link

Screen shot of CITI Add a Course selection.

Human Subject Research Spanish and Good Clinical Practice Spanish will both be available as options to choose on the next page.

Screen shot of CITI Question 1 Spanish Option selection.

Protected Analytics Computing Environment (PACE) Cost Estimates

Protected Analytics Computing Environment (PACE) is a highly protected virtual network space that serves as a marketplace where approved users can work with identifiable protected health information. PACE simplifies the effort of obtaining EHR (Electronic Health Record) data from Duke Health enterprise data warehouse and Duke's Maestro Care (Epic) EHR system.

 

Beginning January 2, 2020, there will be charges associate for the use of PACE. 

mailto:pace_info@duke.edu

PACE charges will be separated into two categories: labor and technology.  For estimates of the labor and technology charges for PACE, contact the PACE team at pace_info@duke.edu or create an estimate in CoreResearch@Duke to obtain the latest rates.

 

 

IRIS/ONCORE UPDATES

 

Two Year Check-In Form Now Available in iRIS

On November 21, 2020 the new IRB Two Year Check-In form will become available for your use in iRIS.  This form has been combined with the Continuing Review (CR) form in iRIS.  To complete a Two Year Check-In form, select “DUHS IRB Continuing Review/Two Year Check-In”.  In the Study Information section, a new question has been added, asking users to select the type of form needed.  New branching logic has been added to route users to the appropriate questions based on selection of either Continuing Review or Two Year Check-In.

 

Under the Revised Common Rule, which took effect on January 21, 2019, most minimal risk studies that received an initial expedited review on or after January 21, 2019 were given a Two Year Check-In requirement.  ( see https://irb.duhs.duke.edu/about-us/irb-news/updated-key-points-new-common-rule-communication-research-community )  Additionally, minimal risk studies that were allowed to transition to the Revised Common Rule were given a Two Year Check-In requirement.  If you have any question about which form (CR form or Two Year Check-In form) you need to complete to renew your IRB approval, please talk with the IRB Specialist assigned to your CRU/Department:  https://irb.duhs.duke.edu/about-us/staff-and-chairs.

 

When it is time to submit a Two Year Check-In form on a study, between 60 to 45 days prior to the study’s expiration date, please complete and submit the Two Year Check-In form in iRIS.  The IRB will review it and if the IRB does not have any outstanding concerns about the study, the study will then be released from all future continuing review or two year check-ins, and will be given an expiration date of 01/01/2100.  If the IRB does have concerns and requires ongoing review, you will be notified in the approval notice.

 

*PLEASE NOTE*:  

 

  • All changes to research and personnel must continue to be reported to the IRB via Amendment, for as long as your study remains open. 
  • All Safety Events must continue to be reported to the IRB according to IRB reporting criteria and timelines. 
  • Closure (Final Progress) Reports are also required as usual when studies close.
  • All FDA regulated studies will still require annual Continuing Review (or more often than annual, if specified by the IRB).

 

iRIS:  IRB Application Revisions

At the request of the Duke Cancer Institute (DCI), there have been a few changes to several sections of the IRB application, specifically related to Oncology studies.  With the exception of the removal of the question located in section 2600 which asked about DCI surveillance, the two other revised questions (located in section 2100 and 2600) were modified to include additional text to help study teams make more appropriate selections.  There is no impact to the applications branching logic or answer selection, therefore this change has minimal impact to the user community.  These changes were communicated during a previous RPM meeting and approved by the IRB.  For additional questions, please reach out to your CRU leadership or IRB specialist.   

 

iRIS:  IRB Amendment

In the coming weeks a change will be made which will require study teams to attach a revision to the DUHS Amendment form regardless of any modifications to the application itself.  In order for OnCore and iRIS to sync data properly, the application must be attached to the amendment. If your amendment does not include any changes to the application form, you are still required to add a revision (attachment) without making any changes to the application if unnecessary.  iRIS will then successfully submit the amendment to the IRB for review upon sign-off.  This change also satisfies several other technical requirements related to KP changes made during amendment submission and other workflow processes for the IRB.   

 

If an application is not attached, the approval details and updated consent information will NOT push over to the IRB reviews section in OnCore.  If you notice missing IRB approval information in OnCore, contact OnCore@dm.duke.edu or submit a service now ticket for support. 

 

iRIS:  Withdrawing Submissions

At times, study teams will need to withdraw submissions that have been submitted for review.  If the submission has been assigned to a review board (CRU, Specialty Committee, CPC, IRB, etc.), the study team will no longer have the ability to withdraw or retract the submission as it has entered into the iRIS workflow.  When this arises, the study team will need to alert the review board of the decision to withdraw, where they will then set a review outcome of Withdrawn.  The submission will then continue to the IRB where an IRB analyst will set the final outcome to indicate Withdrawn.  At that time, no other action will be needed. 

 

 

DOCR NEWS

 

Leadership During Difficult Times- There is no time like the present

Thursday November 19, 2020 at 1:00PM WebEx

 

Leaders need to take steps during any crisis to pivot focus and foster a successful mindset. What are the steps leaders take during a crisis to pivot focus, establish a successful mindset, create clear communication and step up?

When there is a crisis, like we have right now with the pandemic, how can you become a more nimble leader, team and organization?

Denise welcomes input, suggestions! 

Speaker:  Denise Snyder, Associate Dean for Clinical Research

 

Join WebEx: https://dukemed.webex.com/dukemed/j.php?MTID=m5ac7e6ced456baaeb7288ba2bf7c8b2a

Learn more about the Research Professionals Network at docr.som.duke.edu.

 

 

RECRUITMENT INNOVATION CORNER

Alzheimer's & Dementia Outreach, Recruitment & Engagement Resources
The ADORE Project

 

The National Institutes on Aging (NIA) created the new ADORE repository, which includes many resources to support the recruitment and retention of participants into clinical trials and studies for Alzheimer’s disease and related dementias.

A foundational resource in ADORE is the Alzheimer’s Disease and Related Dementias Clinical Studies Recruitment Planning Guide, which identifies ways to overcome barriers to local research participation. The planning guide was developed by the Local, Diverse Working Group, which is part of the National Strategy effort convened by NIA.

Image of the ADORE logo

The guide* includes:

  1. Developing equitable and sustainable community partnerships
  2. Promoting health and science literacy for healthcare providers, community partners, patients, and families
  3. Implementing system reforms to address bias in workforce diversity and cultivate community bridges to broaden outreach.

*While the guide was developed with specific attention to trials for Alzheimer’s and related dementias, most of the content is applicable to any research.

 

NIA is developing a web-based communication tool that will enable researchers to easily produce a “package” of tailored materials and strategies that can be locally branded to help dementia researchers reach, engage, and recruit study participants. 

This tool will allow the research community to access, adapt, and personalize the materials that NIA has developed and tested for underrepresented communities. Sign up to find out when the tool is released!

*These documents were created and edited by 12 diverse community focus groups and many online surveys. There were also Latinx-specific focus groups to review the Spanish messages as well as ones that included people “at-risk” for developing dementia, caregivers, and those with no family history.

Flow diagram of matching participant materials to participants.

As always, please Contact us for any of your research needs!  We can help you develop engaging eConsents, MyChart messages, websites, engagement letters, research notices, and more!  Our services are FREE and you can Email us at studyrecruitment@dm.duke.edu  if you have any questions!

Follow us on Facebook at Discover Duke Research.

 

1Nwanko et al, NCHS data brief, 2013; CDC National Diabetes Statistics Report, 2020; Charlesworth et al, J Gerontol, 2015.

 

TRAINING OPPORTUNITIES

New Online Course:  Budget and Payment Terms Basics for Industry-Sponsored Clinical Trials - DOCR

This new online course Budget and Payment Terms Basics for Industry-Sponsored Clinical Trials - DOCR is designed to help study teams understand the basics of budgeting and payment terms for industry-sponsored clinical trials/research. Learning Objectives - Upon completion of this module, you will be able to:

 

  • Identify the study documents to review when developing a budget
  • Describe the types of costs associated with conducting a study
  • Recognize CRU Management Fees and Duke’s Facilities & Administrative Costs (F&A)
  • Discuss tips for negotiation
  • Discuss common negotiation mistakes
  • Recall preferred payment terms

 

Register Here

 

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.

Image of Duke South Building.

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