Duke Clinical Research Update September 22, 2021

 

 

 

 

 

 

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

 

Additional Guidance on Updated Policies for the Research Community

In a communication on August 11, 2021, Vice President Williams conveyed updates to important research policies at Duke. These policy changes are necessary to assure that Duke is meeting sponsor expectations in the conduct and administration of research. Additional guidance and details related to the implementation of the updated policies can be found below:

 

WHAT HAS CHANGED?

  • Five (5) business day internal deadline. Grant submissions with sponsor due dates on or after October 1, 2021, must be received in final form by the central pre-award offices—the Office of Research Administration (ORA) for Schools of Medicine/Nursing or the Office of Research Support (ORS) for Campus Schools—at least five (5) business days in advance of the sponsor deadline.
  • Full, final document submission. Final documents include all contents of the application as intended to be submitted to the sponsor. Only changes requested/required by ORA/ORS can be made to the application once received by the central pre-award offices for institutional review.
  • Access the five (5) day deadline and Intent to Submit Process frequently asked questions (requires Duke NetID and login).

 

WHAT SHOULD I EXPECT?

  • Investigators applying for external funding must use the “Intent to submit” process in myRESEARCHhome at least 15 business days in advance of the intended submission date. Those units that have not yet implemented Intent to Submit will be contacted in the coming months for orientation to the process.
  • Grant submissions that do not adhere to the internal deadline requirements may not be submitted. More information related to late submissions is in myRESEARCHpath.
  • Applications submitted for external funding without first receiving institutional clearance from the appropriate pre-award office will not be accepted at the time of award notification.
  • Researcher onboarding requirements have been expanded to include new research faculty hired after October 1, 2021, new Duke PIs, and those approved for PI status. Onboarding must be completed before a new award can be processed.
  • Those departments/units who are not yet engaged in the Research Quality Management Program should expect to be contacted by the Duke Office of Scientific Integrity.

 

WHAT COULD HOLD UP SUBMISSION?

Duke University, via ORA or ORS, is responsible for certifying compliance with sponsor requirements at the time that an application is submitted. To ensure that Duke can meet these requirements, Duke may hold a submission if:

  1. Final documents are not received
  2. Internal deadline is not met
  3. Proposal attestation is not completed
  4. Proposed Principal Investigator is not eligible to serve as PI
  5. There is an irreconcilable issue from the “Required Changes” list
  6. The application (w/ approved waiver) is received with less than two days for review

 

Additional information is available in myRESEARCHpath.

 

Please direct all questions to the myRESEARCHnavigators team by visiting the Research Help widget in myRESEARCHhome.

 

News from the IRB:  Co-PI Status in iRIS

Several study teams have reached out to the IRB recently regarding the “rights” given to Co-PIs in iRIS.  As with our previous electronic IRB submission system (eIRB), Co-PIs do not have the ability to sign off on submissions in iRIS.  Only the PI has this ability.  If you find that your PI will be unavailable for an extended period of time, such as a medical, maternity, or family leave, please submit a regular amendment to change the PI.  The new PI can sign that amendment form. 

 

For questions, speak with the IRB Specialist who has responsibility for your CRU.  Please see the DUHS IRB Staff page on the web site:  https://irb.duhs.duke.edu/about-us/staff-and-chairs

 

October is Cybersecurity Awareness Month (CSAM)

October is Cybersecurity Awareness Month (CSAM).  Duke’s Security Offices invite Duke faculty, staff and students to become Security Rockstars by taking the Duke Security Challenge. Duke users can see a dashboard of their individual security posture with steps they can take to improve, including:

  • Enroll in Duke Unlock
  • Comply with the Unified Password Policy
  • List an external email on file for account recovery
  • Enroll in Multi-Factor Authentication for all logins with your NetID
  • Opt in to simulated phishing practice
  • Report phish to the Security Offices
  • Join the "Security Ambassadors" Team
  • Take the Annual Security Awareness training in the LMS

 

Users will be able to see how their personal security posture compares to the overall Duke community. The most secure users will be entered into multiple drawings for prizes during October, including two Grand Prizes and two personalized, autographed books from Coach K!

 

Log in to the self-service portal now with your Duke NetID and password to see your initial posture and get started. Sign up for opt-in phishing by October 1 for the chance to get the most points!

 

 

IRIS/ONCORE UPDATES

 

OnCore Documentation for Clinical Research Participants Policy Updated

The OnCore Documentation for Clinical Research Participants policy was recently updated.

 

Updates were made to the following sections:

  • Expanded Access Protocols that sync from iRIS to OnCore are required to register participants in OnCore
  • Requirements for studies using Summary Accrual in OnCore have been included

 

View the updated policy.

 

Deleting Subjects in OnCore    

If you accidentally register a participant under the incorrect study in OnCore, please be sure you review the Deleting Subjects tip sheet and complete any updates in OnCore and Maestro Care as needed first.  When including PHI in your Service Now request to delete the incorrect registrations, you will need to submit a ticket from the Duke Service Now website, https://duke.service-now.com/sp?id=index, (Get It > Research > Request for OnCore and eReg Binder Support).  Please ensure you include the PHI in the Sensitive Information (PHI) Box.

Screen Shot from OnCore Sensitive Information (PHI) text box

 

 

DOCR NEWS

 

Updated MC Clinical Research 100 Course

The Maestro Care Clinical Research 100 E-Learning course on the Learning Management System has been revised and updated.  The course has been separated into three modules, as follows:

 

  • Module 1:  Access, Navigation and Customization
  • Module 2:  Performing Research Workflows & Managing Participant Encounters
  • Module 3:  Running Reports and Performing Other Research-Related Activities

 

The new format will facilitate navigating through the training and allow the user to track their progress within each module.  The time required to complete the training is still approximately 2 hours.  The Offering ID (00129623) for the training has not changed.  If you have completed the training before and would like to complete it again to provide feedback, we would like to hear from you.  Please submit feedback to michelle.calkins@duke.edu.

 

Direct link to LMS course:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=dowbt000000000036944

 

 

RECRUITMENT INNOVATION CORNER

Thanking the Heroes: Returning Aggregate Study Results to Participants

Currently the focus of most investigators is to publish results of their research in academic journals; however, these results are often not communicated to the public or to the participants who contributed to the success of the research study. As our health care culture shifts toward greater participant engagement and open science, there are increasing demands to return aggregate study results to participants who made the research possible. Developing and disseminating lay-friendly research result summaries to participants demonstrates respect and appreciation for their contribution to advancing science at a relatively low cost.

 

The RIC has drafted a Return of Results Guidance and Template for study teams and will be fielding it for feedback in the near future. Below are the RIC’s Principles for the Design, Development and Distribution of Return of Results Plain Language Summaries (PLS):

 

  • The primary audience for RoR plain language summaries (PLS) are clinical trial participants or their designees. As such, PLS should be written in simple language with attention to principles of readability, health literacy and numeracy, as well as cultural preferences and needs.
    •  PLS may also be provided to the general public, including the media, patient advocacy groups, community-based organizations, etc.

 

  • Sharing aggregate study results demonstrates respect for the time, effort and commitment of study participants and their partnership with the research enterprise. Results should be shared with all participants (or their legally authorized representatives) who signed consent for the study (and opted to receive the PLS), regardless of whether they completed the study.

 

  • RoR Plain language summaries should be developed and distributed in ways that are balanced, factual, and non-promotional. The PLS should reflect the study findings objectively, without bias.
    • Content for the PLS can come from a variety of sources, including the consent form, protocol, clinical study reports, publications, posters, abstracts, or ClinicalTrials.gov.
    • Content should be clear, focus on the results of the study in question, and provide information about where to turn for questions or additional information.

 

  • PLS should be reviewed by the study team, a medical communications group (if available) and reviewers with varied experience and perspectives prior to release.

 

Every study should plan to share the summary/aggregate results with individual participants in a manner that is easy to access and interpret, preferably delivered according to the participant’s stated preference (e.g., email, website, text message, video, print, etc.). At minimum, results should be provided to all participants (or legally authorized representatives/guardians as designated in the ICF) who were consented, regardless of whether the participant was later randomized or completed the study and who have opted to receive results. RoR Plain language summaries should also be made publicly available to our community.

 

If you’d like to get a copy of the draft guidance, template or examples of lay summaries, please reach out to Jamie Roberts (Jamie.Roberts@Duke.edu)

 

By the way, we’re still looking for study teams willing to volunteer for the Research Participant Perceptions Survey. If you’re interested in learning more, please complete this super-short survey.

 

As always, please Contact us for any of your research outreach, recruitment and retention needs!  We can help you develop a strategic recruitment plan with the right tactics, develop engaging eConsents, MyChart messages, websites, engagement letters, research notices, returning aggregate study results, building stakeholder engagement plans and teams, and more!

Follow us on Facebook at Discover Duke Research.

 

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 Oncology CRU would like to congratulate Nick Jeffries, the new RPL for the NCTN Research Team!
  • The Department of Population Sciences CRU welcomes Maya DasGupta, CRC.

 

Send your Clinical Research Employee Highlights to Holly.Tiemann@duke.edu

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

Image of Duke West Campus Building

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



 

 

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