01 November 2023

Duke Clinical Research Update: October 18 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.

Tuesday, November 14, 2023 from 12:00 – 15:00
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.

DUHS IRB: Consent Forms

The IRB has revised the Adult and Minor Sample Consent Forms. These new templates should be used for any new consent form being submitted to the IRB. You do not need to revise currently approved consent forms to match the revised template. You should notice that these templates include simplified language and easier to read fonts for participants, as well as clearer instructions for study teams. You can find the new sample consents on the IRB website at https://irb.duhs.duke.edu/forms/consent-form-templates

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.

IRIS/ONCORE/eReg UPDATES

iRIS: Attach Multiple Documents Workaround

There has been an issue identified in iRIS when using the ‘Add Multiple Documents’ button. When you attempt to upload multiple documents and save, the documents may not appear in the Document Upload area or under Submission Components area. While the documents are successfully uploaded to the study, they do not always successfully attach to the submission form.

When using ‘Add Multiple Documents’ in a form or ‘Add Multiple Documents’ in a Response/Correction Form, please review that your documents appear as expected.

As a workaround, if the documents do not appear as intended, click on ‘Select or Revise Existing’, select the document(s) you attempted to upload, then click ‘Attach’. Once you click ‘Attach’, your documents will appear as expected.

If you are attaching documents to the Submission Components area, click on ‘Add New Component’ > ‘Other Protocol Document’, and select the document(s) you attempted to upload, then click ‘Attach’. Once you click ‘Attach’, your documents will appear as expected.

"CPC" Changed to "PRMC" in iRIS

Throughout the iRIS system, the terms “CPC” or “Cancer Protocol Committee” have been replaced with “PRMC” and “Protocol Review and Monitoring Committee” to reflect the updated name of this committee. These changes include Review Board assignments, Submission History details, and Outcome Letters, among other items. PRMC processes remain the same but the nomenclature has been updated.

DOCR NEWS

Introducing the New Industry Study Start-Up Timeline Dashboard

DOCR has a new dashboard that we are rolling out: the Industry Study Start-Up Timeline Dashboard. This tool will help monitor the institutional approval process for industry-sponsored studies using OnCore financials from the first record of the protocol in an electronic system (iRIS, OnCore, or Innovate) to institutional approval. This dashboard helps you track the various stages, including budget and contract negotiation, Maestro build, and IRB approval.
This dashboard empowers us to make data-driven decisions, identify bottlenecks, and optimize our workflow as an Institution, and ultimately accelerate the start-up timeline for industry-sponsored studies.
We currently have 3 views:

Approved Studies: This dashboard displays aggregate start up timelines for all industry funded studies reaching institutional approval. The three tables on the bottom break out step by step detail for OnCore, iRIS and Innovate workflows. This data allows teams to quickly identify bottlenecks at a portfolio level.
Awaiting Institutional Approval: A near real-time view of the entire start-up process for studies pending institutional approval. This provides overall number of days in process and details on the progress.
Protocol Details: Allows user to open a single study and explore the details to identify any bottle necks for studies awaiting institutional approval.

This dashboard is now available to anyone in the School of Medicine or School of Nursing. You will need to be on the network or VPN in order to access the dashboard. You also will find a map of the process and details on the data on separate tabs in the dashboard.
We will continue to work on dashboard expansion. Currently, we are adding details from the specialty committee review process from iRIS.
For any questions or inquiries about the dashboard, please reach out to your CRU leadership. This dashboard has been available to the CRU Directors, Research Practice Managers, Associate Research Practice Managers, and Financial Practice Managers for a few months so they can help you navigate if you have any questions.

DOCR Policy for Hosting Minors in Clinical Research

In collaboration with the IRB, Compliance and other offices, DOCR has developed and posted the Policy for Hosting Minors in Clinical Research. The policy can be located on the DOCR Policies page under Study Start-up. The policy describes the requirements and permitted activities for individuals under the age of 18 who will be hosted by clinical research teams. If you are planning to host a minor, please note that you must register with the Minors in Duke Programs office and fulfill their training requirements. For questions about the policy, please contact susan.budinger@duke.edu.

Save the Date: Research Wednesdays Inclusive Language and Equity, Diversity and Inclusion (EDI)

The Research Wednesdays series will be hosting two sessions dedicated to Duke Health’s Inclusive Language Initiative and Equity, Diversity, and Inclusion (EDI). Be sure to mark your calendars for these upcoming sessions:

• October 25, Equity, Diversity, and Inclusion (EDI), Dane Whicker
• November 8, Reproductive Language Changes, Evan Myers and Sharon Ellison

Research Wednesdays sessions are held the second and fourth Wednesdays of the month from 1 – 2 PM via Zoom.

Meeting invitation links will be sent to the DOCR listserv the Monday prior to the session. To be added to the DOCR listserv, email your request to docr.help@dm.duke.edu

Upcoming topics and past session recordings of the Research Wednesdays series can be found here: https://medschool.duke.edu/research/research-support/research-support-offices/duke-office-clinical-research-docr/docr-0

Research Professionals Network (RPN): Growing Your Toolbox - Tips and Tricks I Learned from Growing Mine

October 19th at 1:00 PM

Growing Your Toolbox – Tips and Tricks I Learned from Growing Mine

Speaker: Denise Snyder, MS, RD, LDN
Associate Dean for Clinical Research
Duke University School of Medicine
Duke Office of Clinical Research

Session description: What’s the rush? Take time now to build your toolbox! A career takes a lifetime to fully develop and flourish. I’ll share with you my own experiences that led to my career development during my tenure at Duke (23 years and counting).

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.

RPN+ Foundational Series Topic for October

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: Tips and Tools for Communicating with Clinical Research Participants
Date and Time: October 26th at 1pm

After attending this session, you will be able to:

Describe rules and regulations governing communication with research participants
Understand the principles of literacy, numeracy and plain language and how to apply them when communicating about clinical research
Recognize the importance of narrative and story-telling when communicating about clinical research
Identify tools, templates, guidelines and resources for improving how you communicate about clinical research

Click here to register to attend

Clinical Research New Hire Cohort Mentoring Opportunity

Are you looking for an opportunity to build your leadership skills and/or enhance your Tier Advancement portfolio in 2024?

If so, consider becoming a mentor for new clinical research hires through the RPN+ New Hire Cohort program. Any clinical research professional in a Tier 2 position or higher can be nominated or nominate themselves to become a mentor. The commitment is about 4 hours a month for 6 months and we are looking for 9 mentors to support clinical research new hires in 2024! If you think you or one of your employees would be a good fit, then please don’t hesitate to reach out. If you are interested in nominating yourself, please discuss the time commitment and leadership growth opportunity with your manager as a first step. Learn more on the DOCR Onboarding and Training page.

If you are ready to become a mentor or nominate someone on your team, click here to complete the nomination form.

Want to Sign your New Hires up for a Clinical Research New Hire Cohort?

The New Hire Cohort Registration form is always open and available at the end of this newsletter, at this link, and on the most recent version of the Onboarding Learning Plans. Those registered will enter a cohort at the beginning of the month following their registration date and meet 2x a month with an assigned mentor and other new hires throughout their first 6 months. Meetups may include a learning element, networking activities, and space for open conversations about challenges and successes. Each cohort will have a Teams Channel “hub” for meetups and sharing ideas and advice. We estimate around 1-1.5 hours per month time commitment for new hires.

Phlebotomy Competency for Research Classes 2024

Phlebotomy Competency for Research classes are held via Zoom. The Zoom link will be sent to all registrants via e-mail a day or two prior to the scheduled class.

Wednesday, January 3, 2024, 1:00-3:00 p.m. via Zoom
Offering ID: 00184862
Registration Link

Wednesday, February 7, 2024, 1:00-3:00 p.m. via Zoom
Offering ID: 00184863
Registration Link

Wednesday, March 6, 2024, 1:00-3:00 p.m. via Zoom
Offering ID: 00184864
Registration Link

RECRUITMENT INNOVATION CORNER

Custom Slugs Now Available for Clinical Research Web Pages

Nah, we’re not suggesting that the cute, slimy critters that are the bane of many gardeners can help your research in any way. What we’re talking about here is the portion of a URL that comes after the web domain to identify a particular page on the internet.

It is becoming common practice to use REDCap or Qualtrics surveys to help prescreen study candidates. There can be a downside to these great platforms, though. They don’t typically generate very memorable URLs! QR codes are great for flyers, but it’s also helpful if your website’s address is easy to remember and that is very unlikely to happen if your survey URL is something along the lines of https://redcap.duke.edu/Ic8ntREm3mB3rTh1s or https://duke.qualtrics.com/f0rg3tA8out1t.

However, DHTS analysts have recently upgraded the Duke.is URL shortening application to let you create custom slugs for any website! In addition to a QR code, you can now make up an easily remembered URL for any study website you want to share with study candidates.

Making a shortened URL with a custom slug is easy. Here are the steps:

STEP 1
Navigate to the Duke.is online application and enter your DHE credentials when prompted.

STEP 2
Fill out the informational fields on the right-hand side of the app’s homepage to create your URL and destination.

STEP 3
Bask in the satisfaction of having a study URL that nobody can forget!

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, returning aggregate study results and more!

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.

REDCap: eConsent and Multi-Language	October 20, 2023	11:00 AM
Urine Pregnancy Screening for Research	October 26, 2023	1:00 PM
Phlebotomy Competency for Research	November 1, 2023	1:00 PM
Urine Pregnancy Screening for Research	November 9, 2023	1:00 PM
Workshop: Start Building in REDCap	November 10, 2023	10:00 AM
Urine Pregnancy Screening for Research	November 16, 2023	1:00 PM
REDCap: Building in the Data Dictionary	November 17, 2023	11:00 AM
Phlebotomy Competency for Research	December 6, 2023	1:00 PM
Workshop: Start Building in REDCap	December 8, 2023	10:00 AM
Information Security for Research Staff	December 12, 2023	10:00 AM
Urine Pregnancy Screening for Research	December 14, 2023	1:00 PM
REDCap: Learning to Manage Surveys	December 15, 2023	11:00 AM

CLINICAL RESEARCH EMPLOYEE HIGHLIGHTS

• Neurosurgery welcomes Harrison Hockenberry, CRS, Sr. to the team!

The deadline to register October new hires for their cohort is 10/31/2023. Any October new hires registered after 10/31 will be placed in a later cohort. The October 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)