Duke Clinical Research Update April 7, 2021

Wednesday, April 7, 2021
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, email DOCR-maestrocare@duke.edu for meeting invitation.

Click for SlicerDicer Tipsheets

 

PACE Office Hours

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

 

RESEARCH COMMUNITY NEWS

 

Clarification:  Process for Submitting ClinCard Requests

Note that the overall process for submitting ClinCard requests has not changed.

If you are a Study Team Member:  Requests for ClinCards should follow the existing process established by the department and CRU. Specifically, submit requests through your ClinCard Site Administrator, per your unit’s procedures.

If you are a ClinCard Site Administrator:  If you are a site administrator responsible for communicating directly with Employee Travel and Reimbursement, requests should now be submitted to the ClinCard email box:  clincard-request@duke.edu

We apologize for any confusion.

 

Maestro Care Upgrade Scheduled for April 11

On April 11, 2021 Maestro Care will undergo an upgrade that will affect the Research Studies Activity, including how SmartSets are used and how information in SlicerDicer is accessed.  The upgrade also includes changes to the timing of when notes, lab results and imaging results are released to the Patient’s My Chart to comply with the 21st Century Cures Act requirements.  Please review the Maestro Care 11APR2021 Upgrade Research Job Aid and use it as a guide as you navigate the system after the upgrade.

 

Additional upgrade materials:  Clinical Upgrade Documents

 

NEW policy on DUHS Clinical Nursing Services for DEPRU

The Duke Early Phase Clinical Research Unit has worked with the IRB and DUHS nursing to issue a new policy using clinical nursing services:  Research Requirements for DUHS Nursing Services for DEPRU and Duke Research at Pickett (R@P)

 

DUHS nursing staff will provide care that falls within their scope of practice and for which they have completed DUHS required competency training. We anticipate this will be a welcome change as study teams will no longer need to gather names, licenses, curriculum vitaes, and file amendments adding all DUHS clinical nurses to key personnel in the IRB. 

 

Town Hall on Research Data Initiative

The Office of Research and Innovation is hosting a Research Town Hall on April 29th from 12:30 PM -2:00 PM to discuss Duke’s Research Data Policy Initiative. 

This effort is aimed to:

  1. facilitate efficient and quality research
  2. ensure data integrity
  3. foster a culture of data sharing 

This event features a faculty panel, discussing the challenges and successes of managing research data.  A second panel of experts will highlight institutional resources that support and facilitate high quality research.  More information about the initiative, including a link to register for the event, can be found here.

 

Updates from the Duke University Libraries Research Data Working Group

Logo for Duke Research Data Repository

 

Ethical and Equitable Practices for Sharing Data

Do you work with human subjects? Are you being asked by a funder or journal to share your data beyond the original research team for the purposes of reproducibility, transparency, and reuse? Writing consent forms that allow for data sharing is an important step! In an upcoming workshop on April 14, the Center for Data and Visualization Sciences will provide an overview of informed consent language for data sharing, de-identification considerations, and other resources to support ethical and equitable data practices. Registration required and seating is limited! RCR credits available for graduate students, faculty, and staff. 

 

Data Drop: A Highlight from the Duke Research Data Repository

The Duke Research Data Repository (RDR) continues to receive outstanding data deposits this year. One dataset that helped RDR usher in 2021 focuses on fascinating neurobiology research which examines circuits and synapses through which forebrain neurons trigger or suppress vocalization in mice. This dataset includes audiovisual materials as well as images.

Title: Data and scripts from: Circuit and synaptic organization of forebrain-to-midbrain pathways that promote and suppress vocalization

Affiliation: Duke Neurobiology; Cornell University

Subject: Neurobiology

Contact: Valerie Michael 

 

Research Recruiters and CRCs Needed

The CTSI Community Engaged Research Initiative (CERI) is hosting a Community Consultation Studio in collaboration with the Special Populations Core and are seeking 8-10 research recruiters and/or coordinators to serve as participants.

 

The studio will explore Dr. Barret Bowling’s 5T’s Framework to identify strategies to improve the inclusion of African Americans across the lifespan in research studies. Research coordinators will be compensated $50 to share their successful experiences in enrolling and retaining African American participants in research. The studio will be held April 28th, from 8:00am to 10:00am via Zoom.  If you’re interested in participating, please contact diane.willis@duke.edu or call 919.668.8384.

 

The Community Consultation Studio (CCS) is a 1.5 to 2 hour facilitated listening session for health researchers interested in receiving feedback from community stakeholders, e.g. patients, community based organizations, community leaders or lay community. Stakeholders serve as expert panelists and provide feedback on various aspects of a proposed or on-going research project, including the design, intervention, communication materials, participant recruitment strategies, dissemination practices, and application of research findings.

 

Duke Roybal:  If we are all created equally, then why am I treated differently: Contextualizing social determinants in understanding (and explaining) health outcomes among older African Americans

Duke Roybal will be hosting a State of the Science Lecture:  If we are all created equally, then why am I treated differently: Contextualizing social determinants in understanding (and explaining) health outcomes among older African Americans

 

Speaker:  Tamara Baker, PhD, Professor, Department of Psychiatry, UNC School of Medicine

Date:  Thursday, May 6, 2021, 3:00 PM – 4:30 PM

 

LEARNING OBJECTIVES:

  1. Define casual pathways linking environmental, sociocultural, behavioral, and biological factors to health care, management, and health outcomes
  2. Explore determinants of health and intersectionality models to address disparities in health care.
  3. Understand the influence of –’isms’ (i.e. racism, ageism) in contributing to disparities and health outcomes among African Americans
  4. Discuss implementation strategies and identify the levels and domains of the National Institute on Minority Health and Health Disparities’ Research Framework

 

REGISTER HERE

 

Workshop:  Using the NIA Health Disparities Framework to Optimize Equity in Aging Research

 

Logos for Duke Center for the Study of Aging and Human Development, Reach Equity, and Duke Roybal

The Duke Center for the Study of Aging and Human Development, REACH Equity, and Roybal Center are collaboratively hosting a workshop:  Using the NIA Health Disparities Framework to Optimize Equity in Aging Research.

 

Friday, May 21, 2021

1:00PM - 2:30PM EST

 

REGISTER HERE

 

AGENDA:

1:00-1:45          Introduction to the NIA Health Disparities Framework and its use in aging research

1:45-2:05          Case study presentations

A patient-centered approach to address racial/ethnic disparities in pathways to dementia diagnosis–

Dr. Hanzhang Xu, PhD, RN

Leveraging personal meaning for increasing physical mobility in older adults with osteoarthritis pain–

Dr. Jennifer Plumb-Vilardaga, PhD

2:05-2:15          Reflections from Dr. Jones and panelists

2:15 – 2:30       Q&A

 

 

IRIS/ONCORE UPDATES

 

OnCore Updates

The OnCore System was recently updated.

 

Highlights of these updates include:

  • Improved navigation:  It is possible to jump between pages in OnCore using only the keyboard, via the new Jump to location window.
  • Stay on Task: Widgets and Notifications
    • The Active Tasks widget (home page > Active Tasks widget) has been revised to exclude active tasks if the Task List has been marked Complete.
    • Coming Soon! Task notifications:  We will be able to send weekly reminders about pending tasks.
  • Subject Calendars:  An audit history was added to the Subject Visit Update page.
  • Changes to My Console
    • Calendar visits marked as Planned and submitted (My Console > Subject Visits > Pending > [visit] > Subject Visit Update) will now appear in the My Console > Subject Visits > Pending Visits tab.
    • The Actual Visit and Missed columns on the My Console > Subject Visits > Pending Visits tab allowed a subject visit to be marked as occurred or missed without the proper review or validation of the visit details.  These columns have been removed from My Console.
  • Financial Feature Highlights
    • The Withholding Percentage (%) can be edited at any time.
    • Improved Handling and Performance of Pass Thru Invoiceable Items

 

For full text on these updates along with screen shots, see User Updates for the OnCore 2020R3 Upgrade

 

Are you always properly noting Industry-Sponsors as a Funding source within your iRIS application? It is even more important now!

The What and the Why: In association with a forthcoming enhancement to My Research Home, the Project Tracker, it is especially important that you always properly attribute Sponsor Type and Sponsor Role for Industry Funded studies. Failure to do so (among other potential issues) will result in your study not being displayed, as it should be, in that tracker. To reiterate, only those studies that have both a Sponsor Type of Industry and a Sponsor Role of Funding, will display on the Protocol Tracker.

 

The Where and the How: Within Section 700 of your iRIS Application is where all significant Study Sponsors should be individually listed. If you are engaging in an industry sponsored and funded protocol, the Company/Institution providing the sponsorship and funding should be listed as (or among) the sponsor(s) within this iRIS section. When you select the company/institution, please confirm that the Sponsor type is accurately listed as “Industry.” [Or if the Company is not already in the system for selection, make sure that when getting them added, that the Sponsor Type is requested as “Industry”.]

Section 700 Sponsor and Funding Source Add a New Sponsor to the Protocol button in iRIS

 

Once the Sponsor has been selected, make sure to check the “Funding” box in particular, along with any other Role(s) that are appropriate, when completing the ‘Sponsor Role’ section of the Sponsor Details screen.

Protocol Sponsor Details window in iRIS with Funding option checked

 

Then complete the remainder of the Sponsor Details information as usual, including as much accurate and available information as you have at the time.

 

If you have an already pending Industry-Sponsored study application begun in iRIS, and you have any question about whether the above was properly completed, you can check section 700 of your application using the View Details button (see below). And if the funding box was not checked, please Edit and correct that as soon as possible.

Section 700 in iRIS Add a New Sponsor to the Protocol button View Details section expanded.

 

The When: Whenever applicable, please incorporate the above actions when drafting your iRIS protocol applications.

 

 

DOCR NEWS

 

Tier Advancement 2021

Thank you all for your patience and continued collaboration around the Workforce Engagement and Resilience initiative. We are excited to announce the opening up of Tier Advancement for 2021. The timeline will remain the same and is pictured below.

As a reminder, staff in any of the four classifications below may be eligible for Tier Advancement:

  • Clinical Research Coordinator
  • Clinical Research Nurse Coordinator
  • Regulatory Coordinator
  • Research Program Leader

Additional eligibility requirements for Tier Advancement can be found here: Tier Advancement Eligibility Policy.

We will have details forthcoming about proctored testing sessions for coordinators.

Please review the Welcome Packets for your classification as these have been updated with new information!

A new online training for managers has also been added to the Tier Advancement page: Difficult Conversations: Tier Advancement Guide for Managers. See the DOCR training section for additional details.

If there are questions, please visit our website or contact WER-jobs@duke.edu.

Tier Advancement 2021 Annual Decision cycle graphic

Policy:  Clinical Competency for Non-Licensed Research Study Personnel Performing Vital Signs

The Duke Office of Clinical Research has posted the policy Clinical Competency for Non-Licensed Research Study Personnel Performing Vital Signs to the DOCR website.

 

The purpose of this policy is to define training requirements and skills necessary for non-licensed (NL) study personnel to perform clinical competencies limited to vital signs (blood pressure, pulse, temperature, pulse oximetry, respiration rate, body weight and height) for the purposes of collecting this information as required by clinical research protocols. This information should be documented in the research record or in a research encounter note within the electronic medical record system (EMR). 

 

The policy also has a related supporting document:  Vital Signs Training and Competency Documentation for Non-Licensed Research Personnel.  This supporting document can be used to verify training and demonstrated competency in the listed clinical assessments for research subjects.

 

 

Research Professionals Network (RPN):  Taking a Chance at Something Big: Stories from Duke Research at Pickett Road

Adaptability and organizational agility are key leadership competencies in clinical research.  Join us for a discussion of what it takes to be successful in a new research venture when the impacts are big and the path is uncertain. Speakers will include Dr. Lance Okeke, Associate Professor of Medicine and the Duke Research at Pickett Rd Clinical Research Team.

 

Date:  April 15, 2021, 1:00 PM – 2:00 PM

 

Join Zoom Meeting:  https://duke.zoom.us/j/99034926679?pwd=SnZUbXpSczR2MWhKL2pUSTlMUmgyZz09

 

Meeting ID:  990 3492 6679

 

Passcode:  456788

 

Society for Clinical Research Sites (SCRS) Offers Online Modules that have been Mapped to WE-R Competencies

The Society for Clinical Research Sites (SCRS) offers a unified voice for the global clinical research site community.

 

The Duke Clinical Research Community is able to join SCRS free of charge.  Once logged into the site, Duke Community members are able to access 12 online modules that have been mapped to WE-R training competencies.

 

To create your account:

 

Once logged in, go to the Learning Campus tab and select Site Management Modules.  You now have access to 12 modules which outline basic components related to Principal Investigator oversight of clinical trials and the foundational concepts of Clinical Research in accordance with the ICH Guideline for Good Clinical Practice.  These modules allow site staff with less experience to become more familiar with conducting clinical research.

 

To see how the modules are mapped to WE-R competencies, go to the WE-R Competency Training page.

 

Research Wednesdays:  No Session April 14

There will be no Research Wednesdays session on April 14.

 

We look forward to virtually seeing everyone at the April 28th session on OnCore Updates.

 

 

RECRUITMENT INNOVATION CORNER

Trial Innovation Network Toolbox

 

Duke is a member of the Trial Innovation Network (TIN), which is an innovative collaboration across 70 CTSAs in the U.S. The network is working to transform and translate innovative trials and studies into lifesaving therapies, groundbreaking discoveries and more!

 

One vision the TIN has is to resourcefully address critical roadblocks in clinical research.  One of the ways that they have done that is to create a “Toolbox” that acts as an idea-sharing platform for the institutions that participate in the TIN.  They also accept submissions from CTSAs and reputable community health partners and provide them as a free resource to the research community. The materials on this site are designed primarily for the CTSA Program staff and institutions participating in the Trial Innovation Network.

 

Some of the resources that are available are:

  • COVID-19 Recruitment and Retention Toolkit
  • Pediatric Populations in Research: Challenges and Strategies for Recruitment
  • Health literacy checklist
  • Free NIH-Funded resources for cohort retention, patient outcomes assessment, and statistical analysis
  • Referring providers: An outreach guide
  • Study recruitment: using digital tools to increase participation
  • And so much MORE!

Logo for Trial Innovation Network

*The posting of shared resources to the Trial Innovation Network Toolbox is not an endorsement from the Trial Innovation Network, NCATS, or the NIH. Those adopting the resources for their local use are expected to appropriately cite the resources used in the toolbox and give full credit to the original developer, the contributor(s), as well as the Trial Innovation Network.

 

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!

 

Follow us on Facebook at Discover Duke Research.

 

 

 

DID YOU KNOW?

REDCap Can Update Branching Logic for Questions with the Same Logic

In REDCap, when branching logic is updated for one field, the following prompt is displayed:

REDCap screen for Edit Branching Logic field

 

 

Selecting ‘Yes’ will change the logic for all fields in the project that had the original logic that was edited.

 

 

TRAINING OPPORTUNITIES

NEW! Onboarding Tools for Clinical Research Professionals

These tools and tips for using them are on the DOCR WE-R Onboarding and Training Website.

Good news – the DOCR WE-R team just finished piloting new onboarding tools for Clinical Research Professional (CRP) roles! Now that we have incorporated feedback, they are ready for use across CRUs. We hope these tools will assist in building a foundation for continuous competency development throughout an employee’s career at Duke. The new tools include:

  • Onboarding Learning Plans for CRCs and Regulatory Coordinators
  • An Onboarding Checklist for RPMs and ARPMs
  • A Task-Based Template Checklist that you can adapt for any CRP role

 

What’s cool about these tools?

  • DOCR maintains all the tools, including links J
  • All the tools are easily editable so you can adjust trainings/timelines/activities to meet unit and employee needs.
  • The Onboarding Learning Plans specifically include:
    • Standard core learning for the role
    • Customizable learning paths the manager can choose based on need
    • A manageable week-by-week timeline with a weekly competency focus
    • Engagement Activity Packets to connect the dots between online courses and daily work.

 

Which roles have Onboarding Learning Plans?

So far, you will find Onboarding Learning Plans for CRCs and Regulatory Coordinators. We are working on tailoring plans to a few other roles. In the meantime, feel free to adapt the current tools for other roles.

 

Are you going to teach me how to use these Plans?

Of course! There is a quick training for managers on the components of the Learning Plans and how to use the Engagement Activity Packets. In addition, there is a new Onboarding Manager Guide where you can find recommended steps, tips, and FAQs.

If you need further guidance, request a consult with the DOCR Onboarding Liaison.

 

OKAY, WHERE CAN I FIND THESE TOOLS!?

The main launch pad is the WE-R Onboarding and Training website. If you want more information, you will find lots of good stuff there!

 

That’s all for now!

We hope these tools are helpful as you onboard new CRPs to your units. The WE-R team developed these plans in collaboration with CRPs across the CRUs and will make improvements as we receive more feedback. We will be in touch when we finish developing plans for additional roles!

 

New Online Training Module – Difficult Conversations: Tier Advancement Guide for Managers (35-40min)

 

Opening screen for Difficult Conversations:  Tier Advancement Guide for Managers module

Just in time for the 2021 Tier Advancement cycle, this new DOCR module is now available in the LMS! This module was developed in collaboration with Duke HR and takes about 35-40 minutes to complete. It provides Duke Clinical Research Managers with resources, best practices, and communication tips for potentially difficult conversations they may face before, during, and after the Tier Advancement process. The content includes an introduction to a manager’s role in Tier Advancement, as well as six scenarios that may come up during conversations about performance, competency, and Tier Advancement.

 

The lessons include scenarios that address each of the following:

  1. Employee and Manager Disagreement on Readiness to Advance
  2. PI/Manager Disagreement on Readiness to Advance
  3. New Employee (to Duke or Dept.) Wants to Apply for Advancement
  4. Explaining the Difference Between Competency and Performance
  5. 1 on 1 Meetings and Successful Discussions About Performance Issues
  6. Dealing With Negative Results and Generating a Training Plan 

 

The content provides guidance to help develop the following WE-R clinical research competency: Leadership and Professionalism

 

Link to course

You can also find this course on the DOCR WE-R Tier Advancement page under Tier Advancement Training.

 

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 Department of Medicine CRU welcomes Kimberly Carroll, who joined Medicine-ID as a Regulatory Coordinator on March 8, 2021.
  • The Department of Population Health Sciences CRU welcomes Valery Arevalo, CRC, who started on March 15, 2021.

 

PARTNER RESOURCES

DUHS Compliance Office

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