Duke Clinical Research Update February 17, 2021

Wednesday, February 17, 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, via WebEx

Click for SlicerDicer Tipsheets

 

PACE Office Hours

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

 

RESEARCH COMMUNITY NEWS

 

Update:  Process for Adding Duke Students, Unpaid Volunteers, and Visiting Trainees/Interns to Study Personnel

Based on feedback from the community, the Process for Adding Duke Students, Unpaid Volunteers, and Visiting Trainees/Interns to Study Personnel process has been updated.

 

The primary changes include:

  • Including campus graduate students on KP, instead of external KP (to allow reading and writing privileges in iRIS)
  • Clarifying the tables to indicate that either the DUHS IRB volunteer agreement or the DUHS IRB Duke undergraduate student agreement for consent is required for Duke undergraduate students, based on proposed activities.
  • Adjusting formatting for readability.

 

With the issuance of this policy, remote plans for undergraduate students are no longer required to be submitted via REDCap.

 

Click Here for a PDF Version of the Process for Adding Duke Students, Unpaid Volunteers, and Visiting Trainees/Interns to Study Personnel.

 

For visiting research scholars, please contact DOCR.help@dm.duke.edu.

 

SOM Research Building Access

A new online tool for managing SOM research building access for laboratories approved for onsite activities has launched.

 

The Building Access Request tool is available through the MyRESEARCHhome in the Submit a Request menu on the top right of the page:

Image shows the SOM Research Building Access request in myRESEARCHhome

 

During COVID-19 restrictions, access to certain laboratory research buildings was limited and badge access was granted only to those who requested access as part of their on-site approval survey.  A new tool allows research staff or departmental staff on their behalf to request access to a new building and report issues with existing access. It will replace the current manual process of emailing DOCR with access requests and issues.

 

You can begin using the new tool right away. We hope it will be intuitive and quick, but if you have questions or would like a brief tutorial, please email us at VDBS@duke.edu.

 

Important for clinical research:

 

  • For people who are not yet approved to work on-site for clinical research, requests still need to be submitted by the RPM to ReturntoResearch@duke.edu and added to an approved RTR plan.

 

  • For people who are already approved to be onsite and just need access to a new research building, they can make that request using the MRH widget. This only applies to the following laboratory research buildings, all other building access requests are placed through one’s departmental business office.
    • Bryan Research
    • Clinical and Research Lab (CARL) - (no pass through to hospital)
    • Genome Science Research Building (GSRB II)
    • Jones
    • Medical Sciences Research Building (MSRB I)
    • Medical Sciences Research Building (MSRB II)
    • Medical Sciences Research Building (MSRB III)
    • Nanaline Duke
    • Research Park 1
    • Research Park 3
    • Research Park 2
    • Research Park 4
    • Sands
    • Snyderman (Genome Science Research Building GSRB I)
    • Albert Eye Research Institute
    • Duke South/Duke Clinics
    • Wadsworth
    • 323 Foster Street
    • Carmichael
    • Chesterfield
    • Surgical Oncology Research Facility (SORF)
    • Fitzpatrick Center for Interdisciplinary Engineering, Medicine and Applied Sciences (CIEMAS)
    • Levine Science Research Center (LSRC)

 

Estimated Costs for PACE

PACE costs can be found at https://pace.ori.duke.edu/getPACE/ under the Get PACE menu item, Estimated Costs.

Image shows the PACE website with the Get PACE tab highlighted.

 

 

DCRI Research Forum:  Reflections on Race and Medicine During the Year of COVID-19 and Beyond

Date:  Thursday, February 18, 2021, Noon -1 PM

Speaker:  Damon Tweedy, MD, Associate Professor, Psychiatry and Behavioral Science, Duke University School of Medicine

 

The COVID-19 pandemic has highlighted longstanding racial and ethnic health disparities in our country. Coupled with heightened nationwide protests during the summer of 2020, these events have sparked a renewed intensity towards addressing the dilemma of race in America. In his talk, Dr. Tweedy will explore these issues within the medical school and hospital setting, highlighting the challenges faced by Black patients and Black doctors while reviewing recent developments and reforms in the field.

CME Code:  FASMAG

 

Zoom Link for attendance:  https://duke.zoom.us/j/93154390688?pwd=ZFpDd2s4NGI1aVlIdWxBTFkxS3ZsUT09  

 

Duke Roybal Center:  EARLY BEHAVIORAL INTERVENTION DEVELOPMENT: How a Focus on Clinical Significance, Feasibility, and Pilot Studies Can Enhance the Likelihood of Successful Funding

The Duke Roybal Center will be hosting EARLY BEHAVIORAL INTERVENTION DEVELOPMENT: How a Focus on Clinical Significance, Feasibility, and Pilot Studies Can Enhance the Likelihood of Successful Funding on Friday, February 26th, 2021, 2:00 PM – 5:00 PM EST (via Zoom)

 

Speakers: 

Dr. Lynda Powell, PhD

Dr. Kenneth E. Freedland, PhD

 

REGISTER HERE

 

Learning Objectives:

  1. Develop skills in the progressive process of intervention development.
  2. Learn about non-traditional designs that are well suited to early-phase intervention research, such as proof of concept, feasibility, and pilot studies.
  3. Develop skills in publication of, and receipt of funding for, early phase intervention development studies.

 

Contact jessalyn.byrd@duke.edu (Roybal Center Coordinator) with questions.

 

Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator INDs and IDEs

The Office of Regulatory Affairs and Quality announces two upcoming workshops:

 

The Investigational New Drug (IND) Workshop

Speakers: Rachel Johnson, PhD, RAC, Katherine Deland, PhD

March 5, 2021, 9:00 AM – 11:00 AM

 

This workshop will:

  • Define an investigational drug, including off-label use of FDA approved drugs
  • Provide guidance on determining when the IND regulations apply to research studies
  • Discuss the preparation and submission of IND applications to FDA
  • Review maintenance and safety reporting requirements
  • Encourage participant discussion of case scenarios

 

The Investigational Device Exemption (IDE) Workshop

Speakers: Alysa Vereen, PharmD, David Jensen, PhD, RAC

March 12, 2021, 9:00 AM – 11:00 AM

This workshop will:

  • Discuss FDA’s approach to regulation of devices in clinical studies and for marketing
  • Provide guidance on when the IDE regulations apply and discuss possible exemptions
  • Review significant risk and non-significant risk device studies
  • Discuss the preparation, submission, and maintenance of IDE applications
  • Encourage participant discussion of case scenarios

 

Registration Link:

https://medschool.duke.edu/research/research-support-offices/office-regulatory-affairs-and-quality/education-and-training-opportunties

 

 

IRIS/ONCORE UPDATES

 

NEW OnCore Report:  Protocol Status Change Reasons

A new customized report is available that allows you to pull all studies within your CRU and the associated status change reasons for why studies were updated to Abandoned, On-Hold, Suspended or Closed to accrual.  To locate this report, navigate to the Menu > Reports > Reports.

This image shows the OnCore Menu Reports tab

 

The report can be found under Reports > Administrative > Custom Reports.  Click on the link “Protocol Status Change Reasons.”

This image shows the OnCore Protocol Status Change Reasons selection

Once you click on the report link, a new tab opens where you can add the CRU and/or status of interest. Click Submit:

Image shows the OnCore Report Criteria Protocol Status Change Reasons screen

 

The report results include the current study status in OnCore, the status and status date of interest (e.g. suspended or on-hold), the change reason description selected in OnCore and any free text comments that may have been entered.  For studies that were updated to suspended or on-hold (perhaps due to COVID-19), you will also receive the start and stop date ranges associated with those statuses as well as an indication if it was the first suspension or hold added into OnCore (some studies were suspended due to COVID-19, resumed, and were suspended again due to a pending amendment or staffing needs).

Image shows the OnCore Protocol Status Change Reasons Report Result

 

 

DOCR NEWS

 

Research Professionals Network:  Understanding the Burden of COVID-19 in Healthcare Workers: Early Results from the HERO Program

Thursday February 18th, 2021 at 1:00 on Zoom

 

The HERO Registry is a prospective study that launched in April 2020 to evaluate the burden of COVID-19 in Healthcare Workers (HCWs) in the United States. The overall goal of the registry is to create and engage a community of HCWs, and their household members, who may be eligible for participation in future research studies; including those of COVID-19 prophylaxis and treatment. Via an online portal, participants contribute data on medical history, employment characteristics, COVID testing/diagnosis. The HERO registry is the foundation for HERO-Together, a newly launched prospective, observational, multicenter cohort study of vaccinated HCWs. Healthcare workers are able to self-enroll via an online portal and complete surveys on unexpected medical care received post-vaccine. These data will help fill gaps in evidence about long-term outcomes after COVID-19 vaccination.

 

Speaker: Emily O’Brien, PhD, FAHA

 

Zoom Link: https://duke.zoom.us/j/93525152054?pwd=WUpEelY5WHlkSGZiUFR4ZlhxSjBsUT09

 

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

 

 

RECRUITMENT INNOVATION CORNER

Viruses, Pandemics and Burnout, Oh My!

Graphic image of a person experience low energy

Burned out? Exhausted? Stressed? Had it with your mask? Ready to throw in the PAPR and hand sanitizer?

You’re not alone! The COVID-19 Pandemic is creating a hidden pandemic among health care workers.1 If you think “health care worker” only means physicians, nurses, aides, respiratory and physical therapists think again – today, health care worker means anyone working in the delivery of health care to our patients, from front desk staff to research coordinators to social workers and dieticians, etc. More than 50% of health care workers were feeling burned out before the pandemic.2  And these numbers are rising exponentially.3

 

The nation’s healers need strategies for their own healing and well-being! Drs. Patty Lee and Sangeeta Joshi are looking for evidence-based strategies to build resilience and alleviate burnout across our health care teams. Their study, “Targeting Healthcare Provider (HCP) Burnout During Covid-19 Pandemic,” is designed to evaluate the benefits of “Transcendental Meditation” (TM©) as a strategy to alleviate symptoms of burnout among those working in health care facilities.

We recently interviewed Dr. Joshi about pandemic-induced burnout, stress and strategies to help health care workers cope.

 

Q: What are some symptoms of burnout?

A: Feelings of energy depletion or exhaustion, increased mental distance or feelings of negativism or cynicism related to your job, and reduced professional efficacy. Unfortunately, the person experiencing burnout may be unaware of this syndrome, blaming themselves or others without seeking help.

 

Q: Who can participate in your study?

A: We need to address burnout at every level. Most patient-facing health care workers can participate in our study, such as physicians, physician trainees, nurses, APPs, PT, OT, Front desk, RTs, CMAs, CRCs, dietitians, social work/case management, pharmacists, optometrists and medical technicians.  Researchers doing in-person work with patients may be eligible.

 

Q: What should participants expect if they join your study?

A: After pre-screening and baseline visits, participants will be randomized to control group vs TM© group. Participants will be given an Apple Watch so we can monitor data during the study period. Participants can keep the watch after completion of the study.

Participants in the TM© group receive initial training of approximately 75 minutes over 4 days and then self-practice twice daily during the study period. If you wish and are eligible, you may also qualify for getting an fMRI before and after the study to evaluate changes in your brain during stress and changes associated with the intervention.

There are only two in-person study visits required. We have developed an app that allows you to complete most of the screening visits as well as surveys. We can also email web-based surveys to you.

 

Q: But how can incredibly busy research teams do both an initial training session and find time to practice daily meditation?

A: The initial training of 60-75 minutes over 4 days is offered at multiple times over weekdays and weekends to accommodate everyone working in health care today. The daily TM© practice can be done at any location.

Even if you don’t join a study like ours, preventing and/or recovering from burnout requires us to make time for self-care every day – go for a walk, read a book, play an instrument, listen to music, play fetch with your dog – do something to take care of you so you can continue to take care of others. You’re definitely worth it and you have most certainly earned it during this difficult period.

 

Q: What if I want to learn TM and I am randomized to the control group?

A: At the end of the study, you will have option of learning TM© free of cost.

 

Q: Can I join your study now?

A: Yes.  

Here is the link you can use to enroll: https://redcap.duke.edu/redcap/surveys/?s=PAJKRNCF3H
Alternatively, you can also contact the study coordinator, Jessica.shier@duke.edu

 

1 Shanafelt T, Ripp J, Trockel M. Understanding and addressing sources of anxiety among health care professionals during the COVID-19 pandemic. JAMA 2020 April 7

2 National Academies of Sciences, Engineering, and Medicine. Taking action against clinician burnout: a systems approach to professional well-being. Washington, DC: National Academies Press, 2019

3 Dzau V, Kirch, D, Nasca, T. Preventing a Parallel Pandemic — A National Strategy to Protect Clinicians’ Well-Being. N Engl J Med 2020; 383: 513–515.

 

 

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.

 

 

CLINICAL RESEARCH EMPLOYEE HIGHLIGHTS

  • The Department of Medicine CRU welcomes Taheerah Watson, CRS, Sr, joined the Nephrology team February 1, 2021.

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

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