Duke Clinical Research Update September 16 2020

Wednesday, September 16, 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, 2 PM, via WebEx

Click for SlicerDicer Tipsheets

 

PACE Office Hours

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

 

RESEARCH COMMUNITY NEWS

 

Clarification for Clinical Research Staff Symptom Reporting

In response to many questions we have received regarding COVID symptom tracking for clinical researchers, we have reached out across the University and will continue to have conversations to refine and align our strategies across Duke.

 

At this time, we’d like to communicate an update to our recent guidance:

 

All Duke University School of Medicine clinical research employees who have been approved for in-person or on-site research should complete daily screening surveys every work day, regardless of their work location that day. To accommodate the variety of work schedules that we have in clinical research, screening is not required on any scheduled days off whether those days off are vacation, sick, holiday, weekends or other. Details are clarified below.

 

To whom does this apply:

Duke University School of Medicine clinical research staff approved for on-site or in-person work

Duke University School of Medicine faculty approved for on-site or in-person work

 

*students will follow screening protocols per Duke undergraduate, graduate, or medical school requirements

*DUHS staff and SOM clinician faculty will follow screening protocols per DUHS requirements

 

What is required:

Daily COVID symptom screening using either the EOHW REDCap survey or the SymMon app on every work day, whether you are working on Duke premises, in the community, or at home.

 

Update from last message:

Screening is not required on any days off from work.  Depending on your work schedule, this could be weekends or other scheduled days off.

 

The screening surveys, especially the app, are very brief, for the most part asking only about changes since the last screening. If you are reporting to work at a Duke Health location you can use the pass in the SymMon app at the front door in the fast-lane for entry rather than the Duke Health Check app, and we are working with DUHS to ensure that door screeners are aware of this. Tracking employee COVID-19 symptoms is one of the ways Duke is working to keep the community safe as it returns to campus this fall.  

 

If you have any questions or concerns please email DOCR at docr.help@dm.duke.edu.

 

Signatory Official for Certificate of Confidentiality Applications

Effective September 2, 2020, Dr. Geeta Swamy has been designated as the individual to sign Certificate of Confidentiality (CoC) applications to the NIH on behalf of Dean Mary Klotman.

 

In this capacity, Dr. Geeta Swamy will sign Certificate of Confidentiality (CoC) applications for Duke biomedical researchers who are included under the DUHS Federal Wide Assurance (FWA00009025), and will also fulfill all applicable NIH requirements associated with the institutional signer.

 

Changes to the Consent Process during Coronavirus Pandemic and the Need for IRB Amendments

The DUHS IRB has posted a new document: "Updated IRB Guidance on Changes to Consent Process during the COVID-19 Pandemic" dated September 8, 2020.  This document provides further guidance from the IRB regarding the need for an amendment when changes are made to the consent process or platform, due to the COVID-19 pandemic.  Please take a moment to review these important guidelines.

 

https://irb.duhs.duke.edu/node/4722 

 

Zoom Security Change Effective September 27

Starting September 27, 2020, all meetings will be required to either have a Passcode or Waiting Room enabled to ensure safer, more secure meetings. Below are a few scenarios you may encounter:

  • If you already have a Passcode or Waiting Room, there will be no change to how you schedule meetings;
  • If you do not have Passcode or Waiting Room enabled, Zoom will automatically enable a Waiting Room;
  • If you choose to add a Passcode to an already scheduled meeting, you will need to re-send the calendar invitation. Otherwise, Zoom will automatically enable a Waiting Room.

NOTE: This information is for Duke Zoom users only. Duke Zoom Telehealth users will be contacted separately.

For more information, visit Zoom Meetings: Security and Privacy in Your Meetings

If you need assistance, please contact your local IT support group or the OIT Help Desk at oit.duke.edu/help

 

Duke Digital Health Week 2020:  Telehealth Transformed Across The Lifespan

Duke Digital Health Week 2020:  Telehealth Transformed Across the Lifespan will take place from September 21-24.

 

By participating in these sessions featuring expert lead presentations, you will:

  • Learn about the transformation of telehealth amid COVID-19.
  • Discuss telehealth and digital health equity amid COVID-19.
  • See how telehealth services are being transformed for patients, health systems, researchers and payers along with the critical impact on disparities in health care.
  • Explore barriers in telemedicine as providers adjust to an uptick in demand.

 

For detailed information regarding each session and to register, go here.

 

Training Series on EHR Common Capabilities and Leadership Management and Planning for Health IT

Looking for training pertinent to your real-life setting at the intersection of health IT and research?

 

The Regenstrief Institute of Indiana University is offering four 5-week online continuing education classes starting October 5, 2020, on the topics of EHR common capabilities specific to health care and public health applications (2 courses), as well leadership management and planning for health IT (2 courses). Additionally, the Regenstrief Institute, the Indiana Pandemic Information Collaborative, and the Indiana CTSI are partnering to offer a 10-week seminar series starting on October 8, 2020, that will provide a comprehensive review of what we know about COVID-19 and the approaches taken in the healthcare community.

 

The classes are free of charge and will be held via Zoom; 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=YWWE3XWD8H. 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.

 

Duke REACH Equity Center Career Development Awards Funding Opportunity

This is the Reach Equity Logo

 

https://sites.duke.edu/reachequity

 

Career Development Funding Opportunity: Now Accepting Applications through December 7, 2020

 

Consultation sessions available through October – see below

 

The Duke Center for REsearch to AdvanCe Healthcare Equity (REACH Equity) is seeking applications for an internal mentored research career development award (CDA) for junior investigators proposing research related to the Center’s theme of addressing racial and ethnic disparities in health by developing and testing interventions that improve the quality of patient-centered care in the clinical encounter.

 

Although our focus is on intervention, we recognize that the development and testing of an intervention may be beyond the readiness of the science or applicant and/or beyond the scope of this award mechanism.  Therefore, proposals may employ any research method as long as the research addresses disparities in patient-centered care in the clinical encounter, and will clearly lead to the development and testing of an intervention.

 

Consistent with our Center’s goal of increasing diversity in the research workforce, we have set as a programmatic priority the selection of at least 50% of awardees from under-represented racial and ethnic groups. The REACH Equity CDA provides up to $75,000 direct costs per year for two years. Applicants are expected to use the award to protect at least 50% of Total Professional Effort (TPE).

 

Award overview:

  • Eligibility:
    • Research or health-professional doctoral degree or its equivalent. Also eligible: PhD in related fields
    • Instructor or Assistant Professor appointment at Duke University. Fellows or postdocs may apply if they will have a faculty appointment at the start of the award in July 2021
  • Potential applicants are strongly encouraged to meet with the REACH Equity Investigator Development Core Director Laura Svetkey and Center Director Kimberly Johnson to receive input on aligning their proposal with the REACH Equity theme. Virtual information sessions will be available in September and October. Please contact Tia Mitchell, tia.mitchell@duke.edu, to schedule a meeting
  • Individuals considering applying for a REACH Equity CDA are strongly encouraged to submit a Letter of Intent, due by October 27. The form is available to download on the CDA web site here. Download, complete, and send the Letter of Intent by October 27 to Cheryl.j.miller@duke.edu
  • For more information on eligibility and application instructions, visit the REACH Equity Career Development Award web site here
  • Application deadline is 5:00pm, December 7, 2020. Funding begins July 2021.

 

Contact for questions about the program: 

Program Manager:                                        Cheryl Miller, MSG

                                                                                                                     Cheryl.j.miller@duke.edu

Program Director:                                          Laura Svetkey, MD, MHS 

                                                                                                                      Laura.Svetkey@duke.edu

 

 

IRIS/ONCORE UPDATES

 

iRIS/OnCore:  Informed Consent

Do you need to add Informed Consent Details into OnCore for your study?

 

Not all Informed Consent information transmits from iRIS into OnCore.  Study teams need to enter missing consent information into OnCore so all needed consent details are available for subject registration.  Please use this tip sheet on Adding Consent Information to help you with this process.  Protocol Management Access is required to add consents into OnCore.  TIP:  Please ensure consent details are added under the same IRB review in OnCore as the consent was submitted under in iRIS. 

 

What consents DO come over from iRIS into OnCore?

  • Consents that are officially approved and watermarked by the Duke IRB and have a consent category push over from iRIS into OnCore.
  • A consent category must be selected in iRIS or the approved consent details will not push into OnCore.  If the consent is missing a category type in iRIS, the study team will need to manually enter it in OnCore. 

 

This image shows the iRIS fields for adding consent forms

This image highlights the Category field of the Protocol Revision screen in iRIS

What consents DO NOT come over from iRIS into OnCore? 

 

  • The consents for studies using an External IRB of Record (central IRB), are not formally approved by the Duke IRB and do not push over into OnCore.  Study Teams must manually enter the consent information for each of the approved consents (adult/assent/parent consent etc.) as needed each time a new consent is approved by the central IRB (amendments/continuing review). 

This image shows the iRIS UnApproved Consent field

 

  • Phone Scripts and Verbal consents for scheduling in Maestro Care are not approved as consents and do not push into OnCore because they should be uploaded into iRIS as Other Study Documents, not consent forms.  Study Teams must manually enter the information for these types of consents/scripts after initial review and any amendments/continuing reviews. 

 

OnCore Protocol Type Update –Mixed Methods added

A Mixed Methods category has been added to the Non-Oncology Library and is now live.  Mixed Methods studies are defined as research designs that use both qualitative and quantitative approaches and/or paradigms and do not include interventional studies or clinical trials.  The “Assigning Protocol Type in the Non-Oncology Library” tip sheet has been updated to include this option and is posted on the DOCR OnCore Support Page.

 

Is Your CITI Account Linked to iRIS?

In order for someone’s CITI training module completion to automatically update in the iRIS system, the two systems need to be able to link the accounts from one system to the other.

 

In the case of CITI and iRIS, these two systems link on a person’s NetID@duke.edu email address.  Thus, in order for the accounts to sync, the email address in the CITI system needs to be NetID@duke.edu, as opposed to first.lastname@duke.edu.

 

The Duke Office of Clinical Research has created a brief 5-minute mini course, Creating and/or Properly Linking Your CITI Account to Duke Systems – DOCR, which shows how to check your CITI system email address and update it to the NetID@duke.edu format.  Once this has been updated, the two systems will sync, thus reducing the chance of seeing training validation errors when submitting protocols in the iRIS system.  Please take a moment to view this course and check your CITI account to ensure the proper email address is entered.

 

Take the course now!

 

Additionally, the tip sheet Checking CITI Training for an Individual in iRIS has been updated.  This tip sheet walks end users through the process of checking CITI training status for an individual in iRIS and outlines steps to take if the CITI training has not automatically mapped into the iRIS application.

 

 

DOCR NEWS

 

Research Professionals Network:  Practicing Team Science: The Evidence-Base for Effective Collaboration

What makes a team successful? Are scientific teams more innovative than a single investigator? What individual and group factors contribute to team success? The past 75 years have seen an increasing trend toward team-based research, as the problems society faces become increasingly complex. Problems like global climate change, poverty, and health inequities are multi-faceted and therefore require expertise from many fields and backgrounds to address them comprehensively and equitably. This collaborative, cross-disciplinary approach is called “team science,” and the complexity associated with it doesn’t stop with the scientific question; many factors can influence how that work occurs. In this session, we will dive into the literature on scientific teams to understand what works, what doesn’t, and what resources are available to help make your scientific team effective.

 

Thursday September 24th at 1:00 PM on WebEx

Speaker:  Kristine Glauber, PhD, Team Science Core Program Director, Duke CTSI

Webexhttps://dukemed.webex.com/dukemed/j.php?MTID=m463fd83d4a16caa10240266565d75fbe

 

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

 

RECRUITMENT INNOVATION CORNER

COVID-19 Clinical Research Flyers

 

Duke is currently participating in many COVID-19 clinical research studies that are studying different ways to:

  • Understand the virus and how it behaves in the body
  • Find and test treatments for people who have been infected (inpatient and outpatient)
  • Prevent the spread of the disease more effectively
  • Identify and test vaccines
  • Assess the effects of the pandemic on people, communities, and society as a whole

 

While this is an impressive undertaking, more research is needed to better understand this virus and its effects on our health, our communities, and society’s future.  We also know that the only way to find answers to these questions is to have robust participation in these trials.  No participants = no trials!

Graphic of people with masks

That’s why Duke and The MRCT Center (Multi-Regional Clinical Trials) have collaborated on a series of COVID-19 “Should I join…?” clinical research handouts (both in English and Spanish!) that can be used as general information to educate potential participants before they consider joining a trial. These one-page handouts focus on different audiences, such as:

  • Patients
  • Friends/family members
  • Health proxies
  • Parents/guardians
  • Children

 

Our COVID-19 "Should I join...?" clinical research flyers contain information and FAQs for inpatient and outpatient trials, biobanks, and trials for those who have been/are infected and those who are healthy. We should be using these to prepare and empower potential participants and our community by spreading awareness and information about why participating in research is so important in fighting this pandemic!  Please reach out to the RIC if you would like these flyers or find them on Box.

 

Special thanks to MCRT and the Duke Health Marketing team!

This is the Multi-Regional Cliical Trials logo

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!

 

 

 

 

TRAINING OPPORTUNITIES

New Online Course! Just Ask Online: Intro to Health Equity and Diversity in Clinical Research

Developed in collaboration with: Duke Clinical & Translational Science Institute, Duke Office of Clinical Research, and Duke Cancer Institute

This is the opening slide for the Just Ask online course

 

This new course is now available in the LMS and takes about 30 minutes to complete.

  

The course is designed to provide study teams with an overview of the Just Ask concept, health disparities, health equity, and the current state of diversity in clinical trials. The online version of Just Ask begins to frame the ‘why’ around being mindful and intentional in our work to engage and recruit a diverse population of research participants. It also provides a few resources and ideas for how study teams can intentionally begin to incorporate a health equity and diversity lens into study plans.

 

Upon completion of this online course, you will be able to:

  • Define health disparities
  • Differentiate between health equity and equality
  • Recognize the lack of diversity in clinical trials
  • Discuss the importance of diversity in clinical trials
  • Recognize your role and the study team’s role in diversity planning for studies

 

Check out the course!

 

If you would like to learn more on this topic, keep an eye out for one of Dr. Nadine Barrett’s talks or an in-person Just Ask course session.

 

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.

 

 

CLINICAL RESEARCH EMPLOYEE HIGHLIGHTS

  • The DHVI CRU would like to welcome Carter Lovvorn and Brenderia Cameron, who will be working as CRS., Sr.

 

 

PARTNER RESOURCES

DUHS Compliance Office

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Catch up on news from the DUHS Compliance Office.

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