Duke Clinical Research Update

Wednesday, December 4, 2019
By Duke Office of Clinical Research (DOCR)
Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

 

 

 

 

 

Support Office Hour

 

REDCap Office Hours

Tuesdays | 10 am | DUMC Library 212C Seeley G. Mudd Bldg
Thursdays | 2 pm | via WebEx
Fridays | 10 am | Erwin Square Room 1022

 

Slicer Dicer Office Hours

Thursdays | 1 pm | Erwin Square Room 1022 | via WebEx
 

PACE Office Hours

Every other Tuesday, 1 PM, via WebEx. More information.


Research Community News

 

Important Reminder for all Clinical Research Coordinators using Research Smartsets in Maestro Care

Clinical Research Coordinators (CRCs) may place research orders via an approved research smartset.  This privilege is only allowable for the approved workflows outlined below:

Orders placed by Non-Licensed CRCs must be authorized and second signed by a licensed provider prior to becoming active. A licensed provider includes an MD, PA, NP or DO.  Any other ordering workflows are not in compliance with Duke policy.  Please see the screenshot below for orders requiring second sign.

Orders placed by Clinical Research Nurse Coordinators (CRNCs) are authorized and co-signed by a licensed provider. These orders will become active after signature from the CRNC.  Co-sign is required by a licensed provider which includes an MD, PA, NP, or DO.  Please see the screenshot below for orders requiring co-sign.

Additional information regarding Research Smartsets and the Maestro Care for Research policy can be found here.   Contact docr-maestrocare@duke.edu with questions.

 

Use of Standardized Measures or Validated Assessment Tools for Research Quality Improvement Studies

In response to the use of standardized measures or validated assessment tools in research quality improvement studies, the Office of Licensing and Ventures has identified two tools which are not suitable for use at Duke.

Duke Investigators who use standardized measures OR validated assessment tools for Research and Quality Improvement studies should NOT to use:

  1. Morisky Scale (medication non-adherence assessment tool).  As an alternative to using the Morisky Scale, the Office of Licensing and Ventures recommends using the Self-Reported Medication Nonadherence Measurement.   The Self-Reported Medication Nonadherence Measurement was developed by Dr. Corrine Voils.  If your study is interested in using this tool, contact Kathy Emerson in the Office of Licensing and Ventures.  The Self-Reported Medication Nonadherence Measurement is also available in Spanish, Malay, and Chinese translations.  For more information and a link to publications:  https://www.surgery.wisc.edu/research/researchers-labs/corrine-voils-phd/self-reported-medication-nonadherence-measurement/.
  2. CERAD modification of the Boston Naming test (neuropsychological assessment tool).  Those interested in this measure must get permission from the copyright holders of the Boston Naming test.

 

Duke’s Statement of General Data Protection Regulation (GDPR) Compliance

The European Union (EU) General Data Protection Regulation (GDPR) is a data privacy regulation that is applicable throughout the European Economic Area (EEA), and to those who collect personal data about people in the EEA, including personal data collected for research.

Duke convened a GDPR Coordination Group led by Duke’s Privacy Officer, with membership made up of key University and DUHS leaders from Compliance and Privacy, Counsel, Information Security, Information Technology, Purchasing, and Research Administration and developed a Statement of General Data Protection Regulation (GDPR) Compliance which includes statements on “Duke University’s Lawful Basis for Collecting or Processing Personal Data” and “Duke University Data Protection Standards.”   You can find additional information posted on the Office of Audit, Risk and Compliance (OARC) Privacy webpage (https://oarc.duke.edu/privacy) under GDPR Information. 

 

Recruitment and Engagement Policy:  Modifying Recruitment Plans

As a reminder, Duke’s Recruitment and Engagement Policy went into effect across all CRUs in June 2019.  Study teams can modify existing study recruitment plans or submit new studies with a recruitment plan that conforms with the updated policy.

Study teams interested in utilizing updated strategies for recruitment will need to complete the following steps:

  • All key personnel must have completed the online training.  Links to training and tip sheets outlining the process for submitting a training confirmation in iRIS can be found on the DOCR Website.
  • The IRB application should outline the specific procedures that will be used for recruitment of subjects.
  • Patient opt-out status within Maestro Care is reviewed before potential subjects are approached or communicated with.

DOCR is studying the impact of changes to the recruitment policy under an approved protocol.  If you are modifying your recruitment plan in alignment with the new policy, please contact Michelle Mack (michelle.mack@duke.edu).

 

Using Digital Health Devices in Research

Did you know that of the research proposals submitted to the Duke Health Institutional Review Board (IRB), the number that include mobile apps or digital health devices has rapidly increased? In the past year alone, 476 new Duke studies (19.5%) indicated that they will use a mobile application as part of the research study. In response, the Duke Mobile App Gateway and the Duke Medical Center Library & Archives have teamed up to provide access to digital health devices that can be used in research and pilot projects across Duke.

The devices can be borrowed by researchers, clinicians, and students across Duke Health and Duke University for research or clinical needs. Currently the collection includes over 30 devices, such as: activity trackers (FitBit and Apple Watch), smart devices (Echo, Google Home, etc.), tablets (iPad, Fire, etc.), virtual reality (Oculus Go), and vital metric devices (fertility, blood pressure, EEG, EKG, vision, auscultation, etc.).

For more information or to check device availability, see the Digital Health Device Collection guide.

Read the Medical Center Library & Archives newsletter and blog for more updates.

 

CTSI Offers Grant Planning Studio

Planning a grant submission?  Have a research idea but aren’t sure where to start to turn it into a fundable proposal? Need to know more about the logistics and feasibility of your project?

Come to a Grant Planning Studio!

The CTSI will be offering Grant Planning Studios every 4 months on the 2nd Monday beginning February 10th. Grant Planning Studios foster the development of innovative ideas and build a foundation for great research across the Duke community.  Faculty and program leaders of CTSA-supported core resources and other Duke research services will be available to discuss and collaborate on designing a research proposal with invited research teams.

The next Studio Session will be held on February 10, 2020 and will include leaders from CTSI Cores and Duke research support resources, leveraging their expertise and experience throughout each of the customized 1-hour Studios. Your Studio will be tailored to your needs based on your application and subsequent discussions with the GPS Coordinators about your needs.

As invited faculty, you will have the opportunity to discuss the design and logistics of your research question and study proposal during your assigned Studio. In addition, you can make connections and build collaborative relationships with research staff and faculty who will work with you to turn your research question into a robust funding proposal by leveraging CTSA resources.

The deadline to apply for the February 10th session is January 13th.   If you have more emergent needs, there is a Rapid Response Team that can work with you.

Apply to attend a Studio >>  https://www.ctsi.duke.edu/gps

 

Duke CTSI Funding Opportunities

CTSI Special Populations Pilot Agreements (LOIs due December 17, 2019)

  • Up to $25,000
  • Purpose: Facilitate research that promotes health equity for groups who have traditionally been under-represented, or excluded altogether, in health research.
  • More information and application details

IRIS/ONCORE UPDATES

 

Need assistance with OnCore Protocol Search?

Protocol Search is a robust search tool that allows you to specify search criteria and then choose additional protocol data to appear in the search results. You can export your search results to a PDF report or Excel spreadsheet.  A Protocol Search Overview video is now available on the DOCR website at the following link: https://duke.app.box.com/file/549588043493

 

iRIS:  Adding Key Personnel to a Study

Are you adding key personnel to your study application in iRIS?  Step by step instructions along with screen shots can be found in the Protocol Application General Section tip sheet.

Having trouble?  Here are two common reasons you may not be able to add someone to your study’s key personnel list and how to solve the problem!

  1. Staff member’s name not found.  If a current Duke Health staff member’s name does not appear in the search field this typically means that the staff member either was not on any study key personnel in the system as of May 2018 or that s/he has not yet logged in to iRIS.  In this case, ask the staff member to log into iris.duke.edu using their Duke NetID and password.  After an initial log-in, their name should appear in the system for potential KP inclusion.
  2. CITI Training Notification.  In this case, the staff member’s name is in the system and you successfully select them for the study application, but at some point you receive notice that the individual cannot be added because her/his CITI Training is not up to date.  In this case, you can check on an individual’s CITI status within iRIS.  For step by step instructions on checking an individual’s CITI status in the iRIS system, see the tip sheet Checking CITI Training for an Individual in iRIS.

DOCR NEWS

 

Research Professionals Network:  Upcoming Events

Social Networking Event

December 12, 2019, 1:00 PM

Trent Semans Great Hall


RECRUITMENT INNOVATION CORNER

 

Have you written your letter to Santa yet?

The RIC invites you to tell Santa what you are wishing for to support your recruitment efforts using this short survey.  We’ll make sure Santa gets all your “letters” so he can put his elves to work building the toys you need.


DID YOU KNOW?

 

REDCap:  Copying Choices Between Fields

You can now copy choices from one of existing set of choices from other fields in this project.

In the field, you want to copy the choices into, click on Copy existing choices:

Click the Use button next to each to import that set of choices into the current field's Choices text box:

Choices copied:


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 Courtney Wimberly, CRC.
  • The Neurosurgery CRU congratulates Anna Thirakul on being retitled to CRS, Sr.

PARTNER RESOURCES

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