Duke Clinical Research Update February 5 2020

Wednesday, February 5, 2020
Logo for Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)







REDCap Office Hours

Tuesdays 10 AM, Medical Center Library 212C in Seeley G. Mudd
Thursdays 2 PM, via WebEx
Fridays 10 AM, Erwin Square Conference Room 1022

SlicerDicer Office Hours

Thursdays, 1 PM, Erwin Square 10th floor

PACE Office Hours

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



New CERI & REACH Equity Center Funding Opportunity—Mandatory Letter of Intent Deadline February 24, 2020

Duke CTSI's Community Engaged Research Initiative (CERI) and Duke’s Center for REsearch to AdvanCe Healthcare Equity (REACH Equity) are seeking research proposals that address racial and ethnic disparities in health by developing and testing interventions that improve the quality of patient-centered care. Applications should include collaborative community-research teams comprised of Duke faculty and stakeholders such as patients and/or community-based organizations. Funding up to $37,500 (total) will be awarded for a two-year period beginning on July 1, 2020. One award will be granted during the 2020 funding cycle.

LINK TO RFA:  https://www.ctsi.duke.edu/news/request-applications-duke-ctsi-community-engaged-research-initiative-and-duke-reach-equity

Key Dates:
•    RFA issued: January 17, 2020
•    Mandatory Letter of Intent due by February 24, 2020. Submit via email to CeRi@dm.duke.edu and Cheryl.jmiller@duke.edu
•    Selected applicants will be invited to apply for funding on or before March 13, 2020
•    Application deadline: April 30, 2020
•    Announcement of Award: Late May 2020
•    Earliest date funding will begin: July 1, 2020

CTSI Funding Opportunities

The CTSI has announced two new funding opportunities:

Duke-NCCU Collaborative Translational Research Awards (LOI due March 10, 2020)
•    Up to $50,000 in funding from Duke CTSI
•    Seeking projects developing new collaborative science teams with investigators from both Duke and NCCU
•    More information and application details
Duke-RTI Collaborative Translational Research Grants (LOI due May 21, 2020)
•    Up to $50,000 in funding ($25k per institution)
•    Purpose: Develop inter-institutional collaborations for new investigator teams conducting novel clinical and translational research that applies or accelerates discovery into testing in clinical or population settings.
•    More information and application details



iRIS Training Validation Errors

Since the recent upgrade to the Summer Release of iRIS on January 17th, 2020, we have become aware of a system bug regarding training validations in iRIS.  In the past, study teams have been able to easily identify specific individuals with non-compliant training.  Since the latest release, the ability to quickly and easily identify specific training validation errors has been displaced.  

While we await a resolution from the vendor, study teams are encouraged to ensure that all study team members have compliant CITI training before adding them to studies.  If training concerns are identified, please submit a Service Now ticket.  Additionally, if you should encounter a training validation error during the submission of your protocol, please submit a Service Now ticket for immediate assistance where the iRIS team will identify each impacted user.

Again, our vendor is aware of the issue and a resolution is forthcoming.


iRIS Highlight:  Adding Key Personnel and Study Contacts

The interface for adding KSP now allows users to add a person as a KSP and a Study Contact on the same screen.  Upon clicking Setup Study Personnel on the KSP section of the protocol Application, a pop up appears to search for and select KSP.   

This image shows the screen for adding KSP in the iRIS system

Under the tab “User Search”, the study author can search for new KSP and select the correct search result.

This image shows the user search tab in the iRIS System.

Next, the user selects the role for the new KSP, whether they would like the user to also be a Study Contact, and clicks Save.

This image shows the Add Personnel Role field in the iRIS System.

After Save, the new KSP will display under the search area, and the user can add the next KSP.

This image shows the Setup Protocol Personnel field in the iRIS System.


iRIS Highlight:  Changes to Reference Numbers

Reference numbers will now appear throughout iRIS in the format “Pro00######-Form Abv-Version.Revision”, e.g., Pro00099999-CR-1.0 instead of as a six digit number.
 This image shows the Protocols Submissions Status field in the iRIS System.
The six-digit number still appears in the Submission History “Print Friendly” view.

This image shows the Workflow Submissions tracking screen in the iRIS system.

This image shows the Workflow Submissions Tracking screen in the iRIS System.



RPLs and CRCs Available!

Did you know DOCR has RPLs and CRCs available for projects like:

•    Manuscript formatting/editing
•    SOP development/writing/revision
•    Project Management
•    Portfolio Management
•    Regulatory and Study Tasks
•    Subject Enrollment
•    CQMP and auditing
•    And much, much more!

Contact DOCR.help@duke.edu or complete this survey https://redcap.duke.edu/redcap/surveys/?s=kEHMtgAPu7 for more information!

Research Professionals Network:  Building your Portfolio for Tier Advancement:  Writing Tips and Strategies

Thursday, February 20th, 1:00 -2:00 PM in Trent Semans Great Hall

This session will focus on strategies for building a successful portfolio for Tier Advancement. In addition, this session will feature a break out time with tables that have RPLs (Tier 2), CRCs (Tier 3), Regulatory Coordinators (Tier 3), and CRNCs (Tier 3) who have successfully gone through the tier advancement process and had to build portfolios.

Attendees will be able to ask for advice from those who have been through the process successfully.

Speakers:  Donna Crabtree and Christine Deeter
Light refreshments will be provided. Please use this link to register.
Learn more about the Research Professionals Network at docr.som.duke.edu



Plain Language Mini-Consult

This graphic shows a person confused by a long list of items.

Did you know?
•    41% of American adults have basic or below basic literacy skills.1
•    About 50% of Americans read at or below 8th grade.2
•    77 million Americans have basic or below basic health literacy skills.3
•    Research participants frequently do not understand fundamental concepts required for participation.4    

The Recruitment Innovation Center offers FREE mini-consultations to develop a Plain Language Summary (PLS) of your research, complete with phrases and ideas you can use in your informed consent Key Information Summary and other patient-facing materials. Simply submit a request (be sure to upload a description of your project (e.g., your consent, research summary, etc.). Within 7-10 days, a member of the RIC team will draft a PLS of your research and send it to you for review which you can review and send back for one round of additional edits.
The PLS will commonly include the following:

 This graphic shows the word Simplify
•    Language you can use to create your Concise Summary for your Consent Form
•    Language that could be used for a MyChart Research Invitation (if applicable)
•    Language or “calls to action” that can be used in other advertising materials, websites, or social media (if applicable)

Use the PLS to create or refine your recruitment material content. The PLS a great tool to use in developing the right level of content for your recruitment materials.

1National Assessment of Adult Literacy: https://nces.ed.gov/pubsearch/pubsinfo.asp?pubid=2006483
2Paasche-Orlow MK, Taylor HA, Brancati, FL. Readability Standards for Informed-Consent Forms as Compared with Actual Readability. N Engl J Med 2003; 348:721-726.  
3America’s Health Literacy: Why We Need Accessible Health Information. US Department of Health and Human Services Office of Disease Prevention and Health Promotion. https://health.gov/communication/literacy/issuebrief/
4AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research: https://www.ahrq.gov/funding/policies/informedconsent/index.html  



REDCap Data Quality Rules

Did you know that you can setup Data Quality Rules?

Data Quality rules can check for discrepancies in your data.  REDCap includes some pre-defined data rules that you may utilize and run. You may also create your own rules or edit, delete, or reorder the rules you have already created. The pre-defined rules listed in red text cannot be modified, reordered, or removed.

Rules can be set up using a literal logic format (e.g., [age] > 65) that will be evaluated as a Boolean value (true or false) after an existing record's value for that field is substituted (e.g., assuming a record's value is 23 for 'age', 23 > 65 evaluates as false). The logic will be applied to all existing records in the project, and for any record for which the logic evaluates as true, it will return it as a discrepancy for that rule. Similar to branching logic and calculated fields, REDCap variable/field names may be utilized in the rule logic by placing the variable name inside square brackets [ ]. Also, for longitudinal projects, you may reference a field on one specific event by prepending the variable name in the logic with the unique event name in square brackets.

They can be found on the left hand side of the project.

This image shows the applications button and the data quality button in the REDCap System.

Data Quality rules only work in data entry mode not in surveys.


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:


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.


•    Population Health welcomes Jamilah Taylor, CRC, QualCore Group


DUHS Compliance Office

This image shows the side of a building on Duke Campus.

Catch up on news from the DUHS Compliance Office.
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