Duke Clinical Research Update June 3 2020

Wednesday, June 3, 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

 

Administrative and Laboratory Building Use: Phase 1

Laboratory and building use:

 

 

For staff who have been approved to return on-site:

  • For those of your who have indicated a need to use laboratory research buildings via your density survey, and don’t already have that access, DOCR is working with the Office of the Vice Dean of Basic Sciences to get those approvals and key card access set up.  You will receive a notification when those have been granted as indicated in the attachment.
  • On-premises approval letters have gone out to everyone who have completed a density survey and the required training.  If you have finished both the density survey and training and have not received a letter, please contact docr.help@dm.duke.edu and copy your RPM or ARPM to keep them informed. If you have not finished your survey and training, we ask that you do so as soon as possible.

Questions should be directed to docr.help@dm.duke.edu

 

VIDEO: COVID-19 Researchers Targeted

The FBI 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 recently presented risks to coronavirus-based research from foreign nation states and showed how an attack would be crafted against Duke research.

 

Here is a direct link to the 5 minute video shown during the webinar: https://warpwire.duke.edu/w/uckDAA/  

 

This video can also be found here:  https://security.duke.edu/ under “VIDEO: COVID-19 Researchers targeted”.

 

Continuing Renewal Notifications for Protocols Relying on an External IRB

Maintaining continuous IRB approval for a study is the responsibility of the Principal Investigator and the study team.

 

To remind study teams of upcoming renewals, the iRIS system will send out automatic renewal notifications for studies using the DUHS IRB as the IRB-of-Record at the 60 and 45 day windows.  For protocols relying on an external IRB, study renewal notices are NOT automatically sent out from the iRIS system to the study team to remind them of upcoming renewals.  For external IRB applications, renewal reminders must be set through a manual process in iRIS.

 

Since iRIS lacks automation to send out renewal notices for protocols relying on an external IRB, it is recommended that study teams set a calendar notification for themselves at the 60 and 45 day mark before expiration.  Regardless of the use of an external IRB or not, study teams should always set calendar reminders for renewal of their studies, and not rely solely on iRIS reminders.

 

Clinical Trials Transformation Initiative (CTTI): Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials

COVID-19 is disproportionately impacting racial and ethnic minority communities across the United States. We are asking everyone involved in clinical trials right now – IRB professionals, investigators, sponsors, participants, and others – to share their experiences and insights for creating effective strategies to engage racial and ethnic minority patient populations in COVID-19 clinical trials

 

In preparation for the webinar, the Clinical Trials Transformation Initiative (CTTI) will collect experiences and input from key stakeholders across the clinical trials ecosystem through an online survey.

 

Please complete the survey by Mon., June 8 at 11:59 p.m. ET. Your responses will be used to prepare for an upcoming webinar that will discuss strategies to address barriers to the inclusion of diverse patient populations in COVID-19 clinical trials. By sharing stakeholders' experiences engaging racial and ethnic minority patient populations in COVID-19 clinical trials, we can learn from each other and overcome barriers to inclusion for these important trials. 

 

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 Financials Console Protocol Events Tab

Protocol Events is a new tab in the Financials Console where you can document that protocol-related events have occurred and are available for invoicing.

 

When added, the event creates an invoiceable item in the Financials Console > Invoiceable Items > Protocol Items section.

Only events that have not been assigned a trigger will be available.

After a protocol event is marked occurred and added on this page, it cannot be assigned a trigger.

If the event had comments entered on the Financials Console > Protocol Related page, those comments appear in the Protocol Related Comments column in the Protocol Events table.

When added, the event creates an invoiceable item in the Financials Console > Invoiceable Items > Protocol Items section.

This image shows the Financial Console Invoiceable tab in OnCore

 

On Hold and Suspended Protocol Status Updates Tip Sheet

The On Hold and Suspended Protocol Status Updates tip sheet is now available on the DOCR OnCore support page for Regulatory Coordinators. 

 

In OnCore, the On Hold and Suspended protocol statuses refer to study enrollment. The statuses available for selection depend on the current status of the protocol in OnCore.  This tip sheet will walk you through how to add the On Hold or Suspended Status and includes screen shots.

 

Listing in the Clinical Trials Directory

 

This image shows the Clinical Trials Directory logo

As research studies begin to open back up, please remember to make sure your study is listed back on the Duke Clinical Trials Directory.  If your study was previously listed on the Directory and is no longer there when you move your study to “Open to Accrual”, please Contact the RIC to assist you.

 

If you have a study that is actively enrolling and do not have it listed, but would like it to be, please don’t hesitate to reach out to the Recruitment Innovation Center to list it!  The RIC can be reached at studyrecruitment@dm.duke.edu or at 919-681-5698.

 

iRIS Submission Form Clean-up Update

On May 6th the OASIS team reported that a system-wide clean-up would take place, which would allow study teams to submit forms that were previously unable to be submitted due to a restriction identified in the January 2020 iRIS release.  The iRIS team and Duke Health IRB are pleased to announce that this issue has been permanently resolved.  Users should no longer encounter errors when submitting amendments and other submission forms within the system.   

If you experience any additional issues, please contact the iRIS Support Desk.

 

 

DOCR NEWS

 

Service Now 101

The Duke Office of Clinical Research handles a lot of tickets from the Research Community.  Here are a few helpful tips to make sure your ticket is routed to the proper team with all of the information needed to process the ticket.

 

Did you know:

 

  • If you copy someone on an email to an address that creates a ServiceNow ticket, such as DOCR.Help@dm.duke.edu, the person you copied does not get referenced in the ticket.  If you need a response to go to someone in addition to yourself, add that information in the ticket.
  • Send Secure emails can’t be opened from within ServiceNow.  If you need to include PHI in a Service Now request, please submit from the Duke website, https://duke.service-now.com/sp?id=index, and include the PHI in the Sensitive Information (PHI) Box

This image shows the Service Now Sensitive Information (PHI) text box

 

 

RECRUITMENT INNOVATION CORNER

Healthcare Worker Exposure Response & Outcomes (HERO)

 

This image shows the HERO logo

 

Because you know what it takes to be a HERO, please consider participating in the Healthcare Worker Exposure Response & Outcomes Registry.

 

The Healthcare Worker Exposure Response & Outcomes (HERO) Registry is inviting any and all U.S. healthcare workers to share their clinical and life experiences.  We’re doing this study to understand the perspectives and problems faced by frontline COVID-19 healthcare workers. After creating a profile on the registry, participants can choose to participate in surveys and receive invitations to future clinical trials. There is no cost to enroll in the HERO Registry, which is completely voluntary, and it only takes only a few minutes to join. You can participate as much or as little as you like!

 

So what do we mean by “healthcare professional”?  We mean anyone who works in a setting where people receive health care!  This can include, but is not limited to:

 

  • Nurses
  • Therapists
  • Physicians
  • CNA’s
  • Research coordinators and leaders
  • Techs (of any kind!)
  • Emergency responders
  • Food service workers
  • Environmental services workers
  • Interpreters
  • Transporters
  • Administrators (PSA’s, FCC’s, SAM’s etc.)
  • And the list goes on!

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We know the stress that our front line healthcare workers are under and appreciate everyone’s service. The HERO Registry is yet another way for our heroes to help fight the pandemic by participating in research that answers crucial questions about how to protect ourselves.

This text box says Uniting our healthcare community to protect the health and well-being of America's frontline workers.

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!

 

 

DID YOU KNOW?

REDCap:  Missing Data Codes

 Codes to standardize missing data can be setup. Fields that have a blank/missing value may be marked with a custom 'Missing Data Code' to note why the value is blank. These missing codes may be used to aid in data analysis by specifying why a field lacks a value.

 

To enable this got to Project Setup > Additional Customizations > Missing Data Codes: Set up your missing data codes for this project and enter both the codes AND their labels for all the categories of missing data that you wish to use in this project.*

This image shows the missing data codes field in REDCap.

 

When entering data, code missing data as needed:

This image shows the drop down menu to code missing data in REDCap.

 

*Always work with your statistician to code appropriately.

 

 

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 Neurosurgery CRU welcomes Jodi Lennon, CRNC, beginning June 1st.  Jodi will be uniquely working as both a CRNC within Neurosurgery and a Nurse Clinician supporting Dr. Derek Southwell who specializes in surgically treating Epilepsy.

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

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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