Duke Clinical Research Update June 2, 2021

Wednesday, June 2, 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

 

Planning to Host an Intern for Fall 2021?

Is your department, unit, or research group interested in hosting an intern in the fall of 2021? Both undergraduate and graduate interns that come to Duke from other institutions for work on clinical research projects must register and onboard with the School of Medicine. The Clinical Research Internship Program (CRISP) will help you navigate that process and can assist with matching your needs to a student from an area college or university who is looking to expand his or her horizons with real world experience. Both undergraduate and graduate interns are currently allowed to be on campus, but must follow any COVID guidelines (https://medschool.duke.edu/about-us/news-and-communications/school-medicine-covid-19-response).  

 

If you are interested in hosting a student this fall, whether you have a specific student in mind or are just generally interested, please submit your research opportunities here.

 

If you want to host a student from a university not currently affiliated with Duke, please email crisp@duke.edu to inquire about the possibility of obtaining the requisite affiliation agreement for that student’s home university. Duke currently has agreements with Campbell University, Durham Technical Community College, North Carolina Central University, and the University of North Carolina at Wilmington.

 

Additional information about including interns, Duke students, or other personnel on your research team can be found on myRESEARCHpath.

 

CAMRD Scanner Update

We are excited to announce that the MRI scanner in the Center for Advanced MR Development (CAMRD) will be getting a hardware and software upgrade in July.

 

The new system will be a Siemens Prisma (3Tesla) with MR XA30A software.  This upgrade includes replacement of hardware including a new gradient system and imaging coils.

 

The anticipated downtime is from July 14 to August 6 2021.  We will be working with study coordinators to ease the impact of this scheduling down time.

 

Study teams with active studies should have received a REDCap survey by email.  Please have this submitted by June 10th.

 

Please contact the CAMRD team via email with any questions: camrd-technologists@dm.duke.edu

 

 

IRIS/ONCORE UPDATES

 

Policy Update:  OnCore Documentation for Clinical Research Participants Who Provide Informed Consent

The following policies have been combined:  Registration of Clinical Research Participants Who Provide Consent and Participant Status and Study Visit Documentation in OnCore

 

The revised policy containing these merged documents is called the OnCore Documentation for Clinical Research Participants Who Provide Informed Consent.  The purpose of this newly merged policy is to define the requirements for documenting study participation in OnCore for participants who consent to clinical research protocols approved by the DUHS IRB.  Note that this policy does not apply to retrospective reviews, exempt studies, or studies using the summary accrual function in OnCore.

 

OnCore Updates for Non-Traditional Studies

A NEW tip sheet is now available at this link to guide the OnCore updates needed for the following protocol types:

 

  • Expanded Access (also referred to as compassionate use) and single patient IND protocols
  • Humanitarian Use Device (HUD)/ Humanitarian Device Exemption (HDE) studies

 

These protocol types do not typically require Institutional Approval unless OnCore financials or participant registration are being used.  If you are working on one of these studies and will be using OnCore financials or would like to register the participants in OnCore, please contact oncore@dm.duke.edu to ensure this protocol moves through the Institutional Approval process.  Otherwise, please follow the tip sheet to Abandon these protocols after Initial IRB Approval is received. 

 

Consent Category Requirement Improves iRIS to OnCore Documentation

The Consent form category is now a required field in iRIS. Per the new policy, Consent Category Requirements in iRIS and OnCore, when submitting a consent form in iRIS (initial, amendment or continuing review submission), the study team must ensure an appropriate consent category (e.g. Adult, Minor, eConsent, Spanish language, etc.) is applied, in addition to the consent form document name, version number and version date.

 

A consent category must be selected in iRIS to ensure all IRB submission approval details push into OnCore. When a consent form is submitted without a category type in iRIS, the associated review and approval details will not push into OnCore from iRIS resulting in inaccurate approval and consent information.

Screen shot of Consent Category in iRIS

 

OnCore is the Institutional System for registering research participants. When registering a participant on a protocol in OnCore, the study team must select the correct consent version the participant signed to ensure appropriate documentation.

 

iRIS:  Amendment Form Change Resolves Save and Continue Error

There has been a change to the Amendment form within iRIS.  Where users once attached the study application in section 1.0 of the form, users will now need to save & continue through the form where they will find the attachment located within section 3.0.  This change was made to resolve a minor error that occurred if a user backed out of the form before selecting save & continue. 

iRIS Screen Shot:  Amendment Form highlighting section 3.0 Attach Application

 

 

iRIS:  Pediatric Risk Language Removal

Previously, in Section 3000 of the DUHS Application, language indicated that if a study included minors, it would be routed to the Department of Pediatrics for Pediatric Risk Assessment. Recent workflow changes no longer require that assessment. As a result, that statement regarding routing to Pediatrics for a Pediatric Risk Assessment has been removed from the DUHS IRB Application and study workflow.

 

 

DOCR NEWS

 

ClinicalTrials.gov Corner

FDA recently issued the first Notice of Noncompliance to an industry sponsor for failure to submit summary results to ClinicalTrials.gov. Failure to comply with ClinicalTrials.gov regulations can result in significant fines, public notices of noncompliance, and withholding of federal funding.

Duke received a positive mention in the latest Clinical Trials Transparency report published by the Universities Allied for Essential Medicines (UAEM). Duke is noted as one of the few universities that is consistently 100% compliant with ClinicalTrials.gov reporting obligations. THANK YOU to the research teams who work with the DOCR ClinicalTrials.gov team! Your hard work not only contributes to an excellent compliance record, but also helps uphold our commitment to research transparency and sharing the important research being conducted at Duke!

If you have questions about the ClinicalTrials.gov requirements for your study, please contact the Duke ClinicalTrials.gov team at DOCR-ctgov@dm.duke.edu.

 

 

RECRUITMENT INNOVATION CORNER

Developing a Diversity Plan

 

Happy Pride Month!  June is the month where we have an opportunity, and an obligation, to reflect on why our LGBTQIA+ community matters.

Pride Month graphic

When talking about gender and sexual orientation, many people want to use correct terminology but don’t have useful definitions or the knowledge to do so. This is especially true when discussing gender. 

People use different criteria for identifying themselves and/or describing their gender, therefore no one should assume the identity of any other person, rather you should allow them to tell you how they want to be addressed or ask them of their preferences.  Clinical research can start to change this by becoming more aware and inclusive when conducting studies.

 

Inclusive Questionnaires

Non-inclusive registration, recruitment, consent and demographic questions may alienate LGBTQ+ populations.  It is the responsibility of the clinical research industry to build as broad a bridge as possible to be inclusive of all underrepresented groups.  You can start by having your demographic questionnaires include:

  • A 2-step question when asking about sex and gender:
    • What was your assigned sex at birth (male, female, other, or choose not to answer)
    • How do you describe your gender? (Female, Male, Transgender female, Transgender male, Non-binary, Gender variant, Gender fluid, Agender, Pangender, Genderqueer, Gender nonconforming, Prefer not to say)
  • What are your pronouns? (he/him/his; she/her/hers; they/them/theirs)
  • Use Parent A and Parent B, or “family” instead of Mother and Father (for children of gay parents, single parents, foster children, etc.)
  • Substitute the inclusive terms, “partner” or “significant other” instead of specifying “husband/wife/spouse”

 

Diversity Plans

It is important to recruit people from diverse racial, ethnic and other marginalized groups in your study (even if your project is not related to minority health or health disparities):

  • Equity – advancing research outcomes for ALL patients, promoting equitable access to innovation, and ensuring that historically marginalized populations are engaged in the research enterprise in order to narrow gaps in health equity
  • Scholarly Rigor – to significantly enhance the generalizability of your results, improve population health, and to explore differences across race, ethnicity, gender, sex, and ancestry
  • Engagement – to learn how to check your internal biases at the door and ask people to participate rather than assume they are not interested or don’t meet the eligibility criteria

Happy Pride Month Graphic

Diversity Strategy

Here are some questions to consider while planning your diversity strategy:

  • What intentional steps can I take to ensure my work is informed by diversity, disparities, and advancing health equity?
  • Who should be at the table when we are making decisions?
  • What assumptions am I making, or not questioning?
  • How can my understanding of diversity and bias shape my role and activities on the study team and with my patients?
  • How robust is our stakeholder and community engagement in our studies, including our multi-site studies?

 

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:  Rule H

Did you know that if you need to update data after updating a calculated field you can do so by executing Rule H in the Data Quality rules?

 

Data Quality rules can be found under the Applications section on the left hand side of REDCap in a project. Click “Execute for Rule H”. If there are any discrepancies, click “view” to view the discrepancies and then click “Fix Calcs now” to fix the calculations.

Screen shot of REDCap Rule H and Fix calcs now button

 

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 Duke Cancer Institute announces:

  • Victoria Sutton joined the DCI Monitoring Team as a CRAII
  • Jo Ann Hannah-Rogers joined the Protocol Review and Monitoring Committee (PRMC) as a Program Coordinator
  • Ali Bender joined the Protocol Review and Monitoring Committee (PRMC) as a Program Coordinator

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

Picture of Duke South Campus Building

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