Federal Updates: Please visit the following page for up-to-date information and guidance for navigating recent Executive Orders  See latest information

15 November 2023

Duke Clinical Research Update: November 15 2023

In this update:

 


RESEARCH COMMUNITY NEWS

CRNC Annual Revalidation

DUHS requires that all RN’s complete an annual revalidation of critical skills in seven core competency categories.  To meet this requirement, we will be offering three revalidation sessions at 3024 Pickett Road, Durham, NC on the dates indicated below.   Please use the REDCap link to schedule for ONE of these three sessions.  There will be prerequisite LMS modules for certain core categories (bring your certificates of completion to the training session).  Prior to scheduling, check with your RPM to determine if your CRU is requiring specific modules or if you can choose.  


Friday, December 15, 2023 from 09:00-12:00
Monday, January 22, 2023 from 09:00-12:00

Be prepared to choose one revalidation module in each of the seven required categories.

CRNCs can access the link here: https://redcap.duke.edu/redcap/surveys/?s=JAEWLPKMELEHRXHX   

Please remember this cannot serve as an initial competency checkoff.  These sessions are a review of critical components for each of the skills or competencies.

 

NIH New Workflow to Check if the Single IRB Requirements Apply

If your next new or competing renewal application includes human participants research, take advantage of NIH’s new Single IRB (sIRB) Requirement Determination Workflow (PDF) to help determine whether your project is subject to the single institutional review board (IRB) requirements. 

Follow the steps in the Workflow PDF to ascertain whether your research falls under the NIH sIRB Policy or the revised Common Rule Cooperative Research sIRB mandate.

Learn more about Single IRB for Multi-Site or Cooperative Research requirements.

 

Duke MedLink to Require MFA for Research Monitors

As of November 10th, multi-factor authentication (MFA) will be a universal setting across all MedLink accounts.

This means that research monitors will also be required to use multi-factor authentication prior to accessing accounts.

From the monitor’s perspective, when the monitor attempts to log in they will be given an option to receive a code via email or SMS.  They will then enter that code and proceed to the MedLink account.  MFA is required every 30 days, so it will not be required every time the monitor logs in to the system
 

CITI: All-Access Webinar Package

The Duke Office of Clinical Research is excited to announce the purchase of the "All-Access Webinar” package through CITI. This package gives you unlimited access to over 60 live and recorded webinars on various topics related to human participants research, animal care and use, biosafety, export control, and more. You can access these webinars by logging into CITI and clicking on the "Add a course" link. On the next page, click “Webinars” to access the full list. You can register for any webinar that interests you and watch it at your convenience. If you have any questions about this package or how to access it, please contact Parker Reeves at parker.reeves@duke.edu. We hope you enjoy this valuable learning opportunity and benefit from the expert guidance and best practices offered by CITI.

 

Legacy eIRB to Move behind Duke Firewall

The Legacy eIRB system will be moved behind the Duke firewall on November 16. 

This means VPN or Citrix will be required to access the application (similar to the OnCore system). 

For more information go to https://duke.service-now.com/nav_to.do?uri=%2Fkb_view.do%3Fsysparm_article%3DKB0037107.

 

News from CTSI: Five-year pain research collaboration with Duke Ortho

Duke CTSI and Duke Ortho have launched a five-year pain research project led by Adam Goode, PT, DPT, PhD, who has been awarded a $3.3 million R01 by the NIH. Recruitment for the community-based BACk Study will take place at Duke Kannapolis, as well as in Durham.

CTSI full text article

Duke Ortho full text article

 

News from CTSI: Pilot award helps researchers develop new intervention for stroke patients

Duke CTSI provided pilot funding for Dr. Bruce Sullenger, and our award has helped support Dr. Sullenger and his team as they work to develop a more potent, rapidly reversible intervention for stroke patients. The team completed their phase 1 clinical trial earlier this year and is on track to begin their phase II trials with human stroke patients.

CTSI full text article

 

Duke Clinical Research Training Program

The master’s program trains clinical researchers in leading-edge investigative practices grounded in sound scientific principles promoting reproducible research and rigorous ethics training and practice.

Application Deadline: April 15, 2024
https://crtp.duke.edu/curriculum

 

Basic Science Research Track

The Basic Science Research Track (BSRT) is an optional customized curriculum for a master’s degree designed specifically for physician-scientists.  This track prepares individuals for careers as physician-scientists across a range of discovery sciences.


Application Deadline: April 15, 2024
https://crtp.duke.edu/curriculum

 

Duke Health Data Science Poster Showcase

The next Duke Health Data Science poster showcase will be held on Friday, December 8, 2023 from 11:00 AM - 1:00 PM in person at the Sarah Duke Gardens Kirby Horton Hall.
 
We invite any member of the Duke community to submit a poster topic and participate in this event, including students, trainees, staff, and faculty. Please join us!
 
How to participate:
 
Please submit your poster topic at: https://duke.qualtrics.com/jfe/form/SV_3eD7GAdoqiuRQ4m 
 
The preferred deadline for poster topics to be submitted is Wednesday, November 15, 2023, but we will accept topics on a rolling basis.
 
After you submit your topic, you’ll then receive a poster template with the correct dimensions. You’ll need to submit your finalized poster by Monday, December 4 in order to have it printed. You will have no cost to participate, and we will print the poster at no cost to you.
 
Poster topics can cover a wide range of potential topics:
 
Health data science is a broad discipline including statistics, informatics, machine learning, data engineering, implementation, process engineering, technology development, and applications. We especially encourage submissions describing experiences with Duke data sources. Student posters describing class projects (at both the undergraduate and graduate levels) are also encouraged. This experience is intended to be especially valuable to individuals seeking to gain experience in presenting their work in front of a scientific audience, and the poster itself can become a valuable part of an academic portfolio.
 
The showcase will include poster judging, with recognitions including best computational thinking poster, and best good DEEDS (Duke ethical and equitable data science) poster.
 
Read more about this call for participation at https://aihealth.duke.edu/2023-cfp-poster-showcase/ 

 

Save The Date: Community Engaged Research Initiative (CERI) Examples from the Field

Barbers, Beauticians, and Researchers Uniting to Improve Community Health

January 26, 2024 | 12 noon - 1 pm EST

From this webinar you will learn about:
1.    The role of barber and beautician communities in fostering health equity through collaborations with academic researchers. 
2.    Successful examples of community-engaged research initiatives involving barber and beautician networks. 
3.    Strategies for building effective partnerships between researchers, healthcare providers, and barber/beautician professionals. 
4.    Challenges and opportunities in advancing health equity through collaborative efforts. 

Join this Zoom :  https://duke.zoom.us/j/96543005881

For more information and to register, go here.

 


DOCR NEWS

Where Can My Research Go?

Have you found yourself with questions on where research data can be stored?

The Duke Office of Clinical Research in conjunction with the Office of Research and Innovation (OR&I) has created a decision tree to aid Duke Researchers and Study Teams when making decisions about their data storage.

The research community can access the Where Can My Research Data Go? decision tree on the DOCR website.

 

 

If study teams have questions regarding data sharing, there is information on MyResearchPath about Open Science and data sharing:  https://myresearchpath.duke.edu/topics/engage-open-science-and-open-scholarship 

 

2024 Engagement, Recruitment, and Retention Certificate Program: Nomination Period Opens December 11th

The 2024 Engagement, Recruitment and Retention certificate program will be held February 2023- August 2023 and nominations open soon! 

DOCR and the CTSI Recruitment Innovation Center (RIC) invite managers and RPMs to consider nominating any Clinical Research Professionals who perform participant engagement, recruitment, and retention activities. 

Check out the program website for course descriptions, time commitment, and a tentative course schedule for the February - August 2024 cohort. The program consists of six core sessions and three chosen electives, with a focus on building competency in inclusive and equitable recruitment and retention of clinical research participants. Participants will attend no more than two sessions per month. 

Those who complete the program will receive a Duke Engagement, Recruitment, and Retention certificate that they can use to boost PEP development accomplishments and Tier Advancement applications. 

The nomination form will be open from December 11th – January 17th
on the program website.

Please direct any questions to Jessica Cranfill (Jessica.cranfill@duke.edu) and Sierra Lindo (sierra.lindo@duke.edu)

 

Have you Innovatively used Technology to Support Clinical Research Studies?

DOCR is looking for innovative (i.e. creative, advanced, original, or new) ways clinical research professionals at Duke are using available technology*, adapting existing technology, or creating new technology to get their work done. Tell us about your innovative technology use by filling out this form. We will feature some of them in a Research Professionals Network+ presentation to share helpful ideas with the rest of the clinical research community.  
*applications, web-based tools, devices, social media, AI, software, digital media/video, etc.

 

Research Professionals Network: An Overview of the 7 Habits of Highly Effective People

November 16th at 1:00 PM

An Overview of the 7 Habits of Highly Effective People

Speaker: Julie Opiteck, PhD
Research Program Leader
Recruitment Team
Duke Office of Clinical Research (DOCR)

Dr. Stephen Covey’s book is one of the most influential of all time in sharing powerful lessons in personal change.
Learn about the 7 Habits and how a simple paradigm shift can improve effectiveness in your work and personal life. 
This session will review foundational concepts of effectiveness, and the principles, paradigms and practices aligned with each habit.

Meeting information for this session was sent to the RPN listserv.  Interested research professionals can join the listserv at docr-rpn@dm.duke.edu to receive meeting invites.

 

ISO: Research Professionals Network Topic Suggestions

We are in search of topics for future Research Professionals Network sessions! DOCR currently hosts two RPN sessions per month for the clinical research community, and we need your help to plan upcoming sessions. Please use the form below to suggest topics (and speaker(s) if possible) for future sessions. 

We welcome topics for: 
-    General RPN: Topics or virtual networking events that would be beneficial for the entire research community. 
-    RPN+ Foundational Series: Foundational topics for newer clinical research professionals. 

Speaking at RPN and RPN+ can be a great opportunity to gain leadership experience. Please feel free to volunteer to speak on a topic of interest to you! 

Complete this form to suggest a topic

 

RPN+ Foundational Series Topic for November

The RPN+ is a special edition of the Research Professionals Network (RPN) that focuses on foundational topics for clinical research professionals. While these sessions are selected with the Clinical Research New Hire Cohorts in mind, the topics may be relevant to anyone in clinical research at Duke and all are welcome to attend!

Upcoming session: Social Media: Is it Right for Your Research?
Speaker: Nick Eberlein | Project Planner, CTSI Recruitment Innovation Center
Date and Time: November 30th at 1pm 

After attending this session, you will be able to:

  • Identify questions to determine if social media is right for marketing your studies 
  • Recall regulations and policies regarding social media marketing at Duke 
  • Recognize benefits of using social media as a recruitment option 
  • Discuss social media ad campaigns and how they work 
  • Find Duke resources for marketing studies on social media

Click here to register to attend

 


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

Detailed information about each offering is available on the DOCR website under DOCR Course List.

Urine Pregnancy Screening for Research November 16 2023 1:00pm
REDCap:  Building in the Data Dictionary November 17 2023 11:00am
Phlebotomy Competency for Research December 6 2023 1:00pm
Workshop: Start Building in REDCap December 8 2023 10:00am
Information Security for Research Staff December 12 2023 10:00am
Urine Pregnancy Screening for Research December 14 2023 1:00pm
REDCap:  Learning to Manage Surveys December 15 2023 11:00am
Phlebotomy Competency for Research January 3 2024 1:00pm
Urine Pregnancy Screening for Research January 11 2024 1:00pm
Workshop: Start Building in REDCap January 12 2024 10:00am
REDCap:  Exporting/Importing and Reports January 19 2024 11:00am
Urine Pregnancy Screening for Research January 25 2024 1:00pm

 


Clinical Research Employee Highlights

The deadline to register November new hires for their cohort is 11/30/2023. Any November new hires registered after 11/30 will be placed in a later cohort. The November cohort will be paired with a mentor who will host bi-monthly group meetups for 6 months. Visit the DOCR Onboarding and Training page for more information about the goals of this mentoring program.
Want to be a mentor for a future New Hire Cohort? Sign up here.


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.
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


From Duke Office of Clinical Research (DOCR)