Duke Clinical Research Update March 3, 2021

Wednesday, March 3, 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

 

Designing Marketing Materials for Research Studies

The Recruitment Innovation Center (RIC) and the DUHS Marketing Team have joined forces to provide guidance to study teams planning their study marketing strategy.  Together, they have designed a marketing checklist that includes information on:

  • Who reviews and/or approves it?
  • When do they review and/or approve it?
  • What are they looking for in their review?
  • What resources are available to help me?

 

The checklist is designed so study teams will know what to expect in terms of review, recommendations and approvals of study marketing materials.

 

The checklist can be found on the DUHS Marketing website: https://corporate.dukehealth.org/duke-health-brand-center/clinical-trials-and-research

 

Radiation Safety Committee has a New Website Address

The Radiation Safety Committee web site has a new address.  Please be sure to bookmark the new address and update your favorites.

https://lsw.duhs.duke.edu/radsafety/consents/    

 

Annual HIPAA Privacy and Security Training Moves from OESO to LMS

Effective March 1st, the LMS Module “Annual HIPAA Privacy and Security Training” replaced the following OESO Modules:

  • HIPPAA/Privacy for Clinicians
  • HIPAA/Privacy for E&O, FMD
  • HIPAA/Privacy for DUPD
  • HIPAA/Privacy for Non-Clinicians
  • HIPAA/Privacy for Research Clinicians
  • HIPPA/Privacy for Research Non-Clinicians
  • HIPPAA Privacy for University (non-Duke Health) employees

 

This transition applies to all of Duke Health.  Staff in the renewal cycle will receive their renewal e-mail reminder from both OESO and LMS.  The class will continue to be auto assigned to employees and managers can run completion reports using the LMS Manager Dashboard.

 

To find the course in LMS, search for Annual HIPAA Privacy and Security Training or use LMS course ID: DUHSCOMP_HIPAA

 

For Questions - Please Contact: Bonni Baird (919) 684-4976 or Bonni.Baird@duke.edu

 

Taxpayer Identification Number (TIN) Validation Guide Revised

Employee Travel and Reimbursement (ETR) has updated the TIN Validation Guide with the following bullets based on feedback:

  • If the site coordinator previously saved a DUID in place of a TIN, they will also receive a banner reminding them that the participants TIN and Name combination is invalid until updated. In this situation, the error can be ignored and the site coordinator should continue with setting up the participant.
  • Employee Travel & Reimbursement will update all participant profiles with DUID’s in the TIN field to reflect the participants correct TIN. An employee’s DUID should be entered in the TIN field with leading zero’s to satisfy the requirement for number of digits needed. Nine digits are required in the TIN field. Example of how to enter a DUID: 000123456.

 

A link to the Guide can be found here:  https://resources.finance.duke.edu/travel/resources/TIN_Validation_Guide.pdf

 

 

A Few Words on Data from the Duke University Libraries Research Data Working Group

 

This is the Research Data Repositories Logo

Share More Data in the Duke Research Data Repository

Now announcing new features supporting the public sharing of large-scale datasets in the Duke Research Data Repository! The importance of open science for the public good is more relevant than ever and scientific research is increasingly happening at scale. The Duke Research Data Repository (RDR) has integrated the Globus file transfer system to streamline publishing large-scale data generated at Duke. As part of the roll-out of Globus, the repository is piloting providing additional free storage (up to 100 GB per deposit) to the Duke community during 2021. Learn more in this recent blog post, get started with Globus and the RDR, or contact us directly with questions at datamanagement@duke.edu

 

Preregistering your study with Open Science Framework (OSF)

Preregistering a study with OSF has several benefits for researchers who are looking to “stake their claim” to their ideas earlier and establish a clear timeline for publishing an article and perhaps also the data associated with their research. The process is straightforward as OSF’s preregistration offers a step-by-step form, beginning with simple metadata to describe your research and research data. As another benefit, Duke is a member of OSF, meaning affiliates can log on with a NetID and password and have registrations display on this Duke-branded page. With over 230 public registrations and 100 embargoed registrations, Duke already has an active community registering projects.  Learn more about preregistrations and other beneficial features of OSF

 

Data Scholar Program Seeking Data Scientists, Computer Scientists, Engineers

Overview

The National Institutes of Health (NIH) Office of Data Science Strategy (ODSS) Data and Technology Advancement (DATA) National Service Scholar Program is seeking experienced data and computer scientists and engineers to tackle challenging biomedical data problems with the potential for substantial public health impact.

 

Today, biomedical datasets are measured in petabytes and comprise data types ranging from DNA sequences to wearable sensor-generated outputs like heartrate. NIH envisions a biomedical enterprise in which data and information generated in the field, laboratory, and clinic are processed and analyzed in real time and readily shared. In an increasingly data-rich world, these advances are essential to the NIH mission of enhancing health, lengthening life, and reducing illness and disability.

 

Achieving this vision requires deep experience in, and knowledge of, data and computer sciences and related fields. To bring talented professionals with this necessary expertise to advance high-impact NIH programs, the ODSS created the DATA National Service Scholar Program. DATA Scholars will substantially optimize and accelerate data science in biomedicine to improve human health and well-being. The program will also encourage transformative approaches that lead to increased efficiency, innovative research, tool development, and analytics.

 

Program Details

The one- to two-year position will begin remotely but may transition onsite at a later date. Applicants should be prepared to relocate to one of the NIH institutes, centers, or the Office of the Director, located in Bethesda and Rockville, MD, or Research Triangle Park, NC. During this period, DATA Scholars will:

  • Lead exciting, high-profile, transformative NIH projects that leverage large data sets to advance knowledge in areas of high biomedical research impact.
  • Directly communicate with NIH senior leadership about projects and topics of importance for the biomedical research community.
  • Collaborate with other DATA Scholars and the NIH data science community across broad disciplinary boundaries in training, discovery, and development of data science skills, methods, and tools.
  • Engage with policymakers, top researchers at NIH and other institutions, and industry partners at the cutting edge of data science.

 

To apply:  https://datascience.nih.gov/data-scholars-2021

 

One position will be devoted to heart failure efforts:

https://datascience.nih.gov/data-scholars-2021/shifting-the-paradigm-of-heart-failure-research-with-advanced-analytics

 

Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator INDs and IDEs

The Office of Regulatory Affairs and Quality announces two upcoming workshops:

 

The Investigational New Drug (IND) Workshop

Speakers: Rachel Johnson, PhD, RAC, Katherine Deland, PhD

March 5, 2021, 9:00 AM – 11:00 AM

 

This workshop will:

  • Define an investigational drug, including off-label use of FDA approved drugs
  • Provide guidance on determining when the IND regulations apply to research studies
  • Discuss the preparation and submission of IND applications to FDA
  • Review maintenance and safety reporting requirements
  • Encourage participant discussion of case scenarios

 

The Investigational Device Exemption (IDE) Workshop

Speakers: Alysa Vereen, PharmD, David Jensen, PhD, RAC

March 12, 2021, 9:00 AM – 11:00 AM

This workshop will:

  • Discuss FDA’s approach to regulation of devices in clinical studies and for marketing
  • Provide guidance on when the IDE regulations apply and discuss possible exemptions
  • Review significant risk and non-significant risk device studies
  • Discuss the preparation, submission, and maintenance of IDE applications
  • Encourage participant discussion of case scenarios

 

Registration Link:

https://medschool.duke.edu/research/research-support-offices/office-regulatory-affairs-and-quality/education-and-training-opportunties

 

 

IRIS/ONCORE UPDATES

 

iRIS 1 on 1 Training Sessions Available

DOCR is offering 1 on 1 iRIS training sessions that can be taken as part of onboarding for those who are new to using the iRIS system. During this 1 on 1 training session, an experienced Regulatory Coordinator will walk through iRIS, providing tips and tricks and answering any questions the learner has about the system. The training can be requested as needed, but will only be offered once for a single individual.

 

This one-time training is open to anyone in a clinical research position and can be requested by emailing DOCR-Training@dm.duke.edu.

 

PLEASE NOTE: Prior to requesting a 1 on 1 iRIS training session, both of the online iRIS training modules in the LMS, Intro to Submitting an IRB Application (00133297) and Post Approval Submission Forms (00121335), must be completed. This is important because it will allow you to familiarize yourself with IRIS and will help you come up with any questions you may have.

 

 

RECRUITMENT INNOVATION CORNER

Duke MyChart for Research

 

Did you know that over 1 million MyChart research recruitment messages have been sent to Duke patients since 2017?  Did you also know that over 700,000 people have been engaged around research through their MyChart portal? 

 

What does that mean?

It means that thousands of patients are being engaged and talked to about research!  Inviting patients to participate in research studies through Maestro Care’s MyChart patient portal is a direct-to-patient recruitment approach. 

 

How does it work?

  • Request a consult with  DOCR Maestro Care analysts to determine if this is appropriate for your study
  • Identify potentially eligible patients in Maestro Care based on discretely documented study inclusion/exclusion criteria (a computable phenotype that will be used to create your Cohort Identification Plan (ChIP)
  • Work with the RIC to create your message
  • Submit your message and recruitment plan modifications to the IRB
  • DOCR Maestro Care analysts send the message on a negotiated schedule to invite patients to learn more about your study.
  • Messages can include processes to launch a virtual study workflow (e.g., links to prescreening surveys or websites) or can generate a Maestro Care in-basket message to you if a recipient clicks “I’m Interested”

 

What are they saying about this tool?

"The use of MyChart for recruitment has really been an important tool which increases efficiency of outreach for some of our PCRC research studies. The RIC and DOCR analysts provide great support in helping to craft the message and to think through the considerations related to volume and timing of messages to send. We have had great success in having patients express their interest in learning more about our studies or decline any interest, both of which helps our team optimize our recruitment efforts.” -Dr. Ranee Chatterjee, Associate Professor of Medicine

This is the Duke MyChart logo

*Please note that MyChart research recruitment messages must be sent via the centralized process managed by DOCR Maestro Care Analysts in coordination with the IRB and Recruitment Innovation Center.

 

To learn more about this process and associated costs, please complete the intake form at https://redcap.duke.edu/redcap/surveys/?s=EKNJ7K3EAL

 

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.

 

 

 

Content Analysis of Recruitment Material

The Recruitment Innovation Center in partnership with Dr. Monique Turner, Professor and Chairperson in the Department of Communication at Michigan State University, are working together to understand messages used to engage people in clinical trials and/or to improve their knowledge, attitudes and beliefs about clinical trials.

 

As part of this project, the Recruitment Innovation Center is conducting a content analysis of strategies that are currently being used by study teams conducting clinical trials. With the insights gleaned from this project and Dr. Turner’s content expertise in behavior change, we may be able to develop and test new forms of clinical trial enrollment messages.

 

With regard to the content analysis of existing materials, we want to develop a message-bank of the tactics and strategies currently used by clinical trials researchers to engage, recruit and enroll participants. These might be in the form of:

  • A script for providers to use when approaching their patients
  • Print materials like postcards, flyers, posters, brochures, etc.
  • Recruitment call phone scripts
  • Direct-to-patient messages (e.g., letters, MyChart Messages, etc.)
  • Website content
  • Videos
  • Text messages
  • Social media ads and/or posts
  • Etc.

 

To this end, the Recruitment Innovation Center is requesting study teams to share your recruitment materials with us so that we can include them in this content analysis.  The team will share the resulting report with everyone who shares content, along with examples of messages that are promising—based on both data and Dr. Turner’s expertise in Public Health Behavior Change, Marketing and Communication.

 

If you are willing to share your materials, please send them to Jamie Roberts.

 

If you’d prefer, you can also send the PRO# to Jamie Roberts and she will obtain them from iRIS. 

 

DID YOU KNOW?

REDCap:  Downloadable PDFs

Downloadable PDFs are customizable. These customizations are located in the Enable option modules and customizations section. Click the “Additional customizations” button and scroll down to PDF Customizations.

 

Set a custom header to appear at the top left of every PDF page, display or hide the REDCap logo and website URL, display or hide a secondary unique field, and hide record ID from the PDF header. Any customizations to the PDFs is applied to ALL instruments in the project.

Image shows the PDF Customizations tab in REDCap

 

 

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 Population Health Sciences CRU welcomes:
    • Abby Rader, CRS, SR, who started March 1
    • Kate Ehle, CRC, starting March 15

 

 

PARTNER RESOURCES

DUHS Compliance Office

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