06 December 2023

Duke Clinical Research Update: December 6 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.

Duke MedLink Will Not Require MFA for Research Monitors

The MFA requirement for research monitors using Duke MedLink has been removed. Due to the re-use of these accounts and the verification needed to ensure PHI safeguards, DHTS removed the need for MFA for research monitors. We appreciate everyone’s help as we navigated this situation.

Resources Available for Research Involving DEA Schedule 1 Substances

Researchers considering protocols with Drug Enforcement Administration (DEA) Schedule I substances can now access a planning checklist. These substances are currently being investigated at other institutions in the areas of anxiety/depression due to terminal illness, post-traumatic stress disorder, major depression, eating disorders, alcohol and opioid use disorders.

The checklist and an associated flowchart are available on the Duke Early Phase Research Unit (DEPRU) website and on myRESEARCHpath.

Duke Health Data Science Poster Showcase

Please join us for the next Duke Health Data Science poster showcase on Friday, December 8, 2023 from 11:00 AM - 1:00 PM in person at the Sarah Duke Gardens Kirby Horton Hall.

The fall 2023 Health Data Science Poster Showcase will highlight the transformative work in health data science happening all across Duke.

We will serve a light lunch from 11:00-1:00, and we invite you to join the group photo at 12:00 PM and the poster award presentations at 12:30 PM.

The Sarah Duke Gardens are lovely and just a short walk from the main hospital: Visitor information

Reserved parking for our event is right next to the building (through the Anderson Street entrance) and you will not have a parking fee.

Submissions Open for Duke’s 2024 Research Data Visualization Competition and Showcase!

Submissions Open for Duke’s 2024 Research Data Visualization Competition and Showcase!
As part of the university's historic centennial celebration, the Office for Research & Innovation is excited to announce the Research Data Visualization Competition & Showcase. Clinical researchers are invited to submit data visualizations that interpret or touch on the theme of “Through Time.”

Submission Deadline: January 8th, 5pm

Click here for Competition and Event Details

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.

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

IRIS/ONCORE/eReg UPDATES

Policy Update: Protocol Status Update Requirements in OnCore

The Protocol Status Update Requirements in OnCore policy was recently updated. The purpose of this policy is to define the requirements for updating the protocol status in OnCore.

The following language was added to the policy:
• Studies that are actively screening potential participants must have an open to accrual status.

DOCR NEWS

Reminder: DOCR Study Eligibility Documentation Policy and Attestation

The DOCR Study Eligibility Documentation Policy provides investigators and research teams with best practices and requirements for creating eligibility source documentation for interventional clinical research studies open to accrual.

The Duke Office of Clinical Research in conjunction with the Office of Audit, Risk, and Compliance is requiring all CRP positions to attest to the Study Eligibility Documentation Policy.

Thanks to everyone who has already completed the attestation.

If you have not already completed the attestation, the email request was sent from the Office of Audit Risk and Compliance and the From line of the address looks as follows:

Updated DOCR Process for Adding Duke Students, Unpaid Volunteers, and External Trainees/Interns to Study Personnel

The DOCR Process for Adding Duke Students, Unpaid Volunteers, and External Trainees/Interns to Study Personnel has been updated to include the following changes:

Updated link for RCR training (students and interns should complete Staff - Responsible Conduct of Research (ID: 199263))
Duke Campus graduate students conducting participant-facing activities for biomedical research studies will require onboarding through CRISP. The definition of a CRISP Duke intern has been expanded to include additional types of Duke students.
Added link to the DOCR Policy for Hosting Minors in Clinical Research.
Student KP documents will be sent to DOCR via the REDCap Student/Volunteer/Intern KP Document Tracking form linked in the policy. Please use the REDCap form moving forward (documents sent to DOCR.help will continue to be processed).
Updated Table 1 to include instructions for uploading documents to IRB and to reflect the CRISP requirement for Campus graduate students.
Updated link for the DOSI visiting research scholar registration process.
Background Check section has been updated to allow use of externally conducted background checks for external students/interns.
Updated flow chart.

The document is located on the DOCR Policies and Procedures page under Study Start-Up Policies. Please contact susan.budinger@duke.edu with any questions.

DOCR Phlebotomy Competency for Research Classes Returning to In-Person Classes in February 2024

Beginning in February 2024, DOCR’s Phlebotomy Competency for Research classes will return to in-person sessions. Classes will be held monthly at the Research at Pickett Road facility in Durham. No remote class option will be available and all registrants must attend in person. A schedule of 2024 classes is available on the DOCR website and listed below. The January 2024 class will be the last remote class available and it is currently available for self-register on the Duke Learning Management System (LMS). The Offering ID for the January 2024 class is 00184862: registration link. Please contact us at docr.help@dm.duke.edu if you have any questions.

If you register for a class and cannot attend, please cancel your registration in the LMS as soon as possible to make the slot available to another registrant.

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

Wednesday, February 7, 2024, 1:00-3:00p.m. at Duke Research at Pickett Rd.
Offering ID: 00187363; Registration Link

Wednesday, March 6, 2024, 1:00-3:00p.m. at Duke Research at Pickett Rd.
Offering ID: 00187376; Registration Link

Wednesday, April 3, 2024, 1:00-3:00p.m. at Duke Research at Pickett Rd.
Offering ID: 00187377; Registration Link

Wednesday, May 1, 2024, 1:00-3:00p.m. at Duke Research at Pickett Rd.
Offering ID: 00187378; Registration Link

Wednesday, June 5, 2024, 1:00-3:00p.m. at Duke Research at Pickett Rd.
Offering ID: 00187379; Registration Link

Friday, July 12, 2024, 1:00-3:00p.m. at Duke Research at Pickett Rd.
Offering ID: 00187380; Registration Link

Friday, August 16, 2024, 1:00-3:00p.m. at Duke Research at Pickett Rd.
Offering ID: 00187381; Registration Link

Wednesday, September 4, 2024, 1:00-3:00p.m. at Duke Research at Pickett Rd.
Offering ID: 00187384; Registration Link

Wednesday, October 2, 2024, 1:00-3:00p.m. at Duke Research at Pickett Rd.
Offering ID: 00187385; Registration Link

Wednesday, November 6, 2024, 1:00-3:00p.m. at Duke Research at Pickett Rd.
Offering ID: 00187386; Registration Link

Wednesday, December 4, 2024, 1:00-3:00p.m. at Duke Research at Pickett Rd.
Offering ID: 00187387; Registration Link

Maestro Care: Patient Access to Research Notes

Currently, Research Notes written in CRC Research Encounters are not sent to patients via MyChart. Even if the note author does not “Click to block this note from the patient,” the note will not be sent to the patient.

Requirements of the 21st Century Cures Act necessitate that we change this process so that patients receive research notes via MyChart unless the design of the study and study consent form indicate otherwise. We realize that there will still be important reasons for blocking some research notes and other types of documentation from patients while they are on particular studies (e.g. to ensure that single-blinded studies remain blinded) and we want to help ensure some pre-identified documentation is not released until it is appropriate to do so.

If you have a study that requires any Maestro Care documentation (progress notes, procedure reports, lab results, etc.) to be withheld for a period of time, or you have concerns about your research notes being sent to patients via MyChart, we want to hear from you. Please contact us at docr-maestrocare@dm.duke.edu and tell us which study you’re working on, what documentation needs to be withheld, and why withholding this information is important to the study. Sending a message to us via docr-maestrocare@dm.duke.edu will open a Service Now ticket and a member of the DOCR Maestro Care team will respond. Thank you!

Maestro Care: Medicaid ID Tip Sheet

The new Medicaid ID Tip Sheet will show you how to find information about a patient’s Medicaid ID in their Maestro Care record. If you have any questions, please contact us at docr-maestrocare@dm.duke.edu. Sending an e-mail to this address will open a Service Now ticket and a member of the DOCR Maestro Care team will respond.

Addressing Order Deficiencies in Maestro Care

When an order is sent to a Provider for co-sign and the Provider declines it, the declination is routed to the In Basket of the end user who entered the order. The In Basket folder that the declination is routed to depends on the type of order – outpatient or inpatient. When this happens, the person who entered the order must reassign it to the correct Provider for co-sign or administratively close the order. Please see the new tip sheet on Addressing Order Deficiencies in Maestro Care for information regarding how to reassign or administratively close an order declined for co-sign.

If you have any questions please reach out to the DOCR Maestro Care team at docr-maestrocare@dm.duke.edu.

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 (RPN): Emotional Eating

December 14th, 1:00 PM

Session Title: Emotional Eating

Speaker: Yen P. Lowder, MS, RD
Clinical Research Coordinator
Duke Office of Clinical Research

The Research Professional’s Network will host the session Emotional Eating.

Session objectives:
•   List at least 3 factors that contribute to stress eating
•   Recognize the gut-brain connection
•   Discuss dietary and life style approaches to reduce inflammation and boost mental health

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.

RECRUITMENT INNOVATION CORNER

Happy Holidays

With Thanksgiving now behind us, we’re moving into the busiest part of the end-of-the-year holiday season. As you know, this is a tough time to recruit and retain people in our studies. Vacations, school breaks, plans to spend time with family, and busier than normal work days for many folks can firmly place research participation out of mind. So, what can we do as researchers to keep recruitment and retention rates stable throughout the holiday season?

Reach out to your Participants!

The Holidays are a perfect time to reach out to your study participants individually with:
➢ A quick phone call to check in and tell someone you’re thinking of them, especially those who you know may be isolated and alone
➢ A personal email sent to them (not just a big chain email)
➢ A letter or holiday card in the mail with a real signature and hand-addressed envelope
➢ An update about the study to share what has been learned so far
➢ Notifications about new and upcoming studies they may be interested in
➢ Plan ahead: many studies have ‘visit windows’ or a range of days in which a subject visit can occur according to the study protocol. Use this to give participants flexibility to minimize visits around the holidays.

Strive to be inclusive in your messaging. Holidays and celebrations happen throughout the year and do not seem to get the same kind of attention that holidays at the end of the year do. Some fall and winter holidays our participants celebrate in the final two months of each year include: Bodhi Day, Christmas, Diwali, Hanukkah, Kwanzaa, New Year’s Eve and Day, Lunar New Year, Yule, and more!

Keeping your participants engaged and updated throughout the holidays and going into the new year will help participants feel that you are doing research with them instead of to them. This time of the year is a perfect time to make them feel important and appreciated.

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! Follow us on Facebook at Discover Duke Research.

DID YOU KNOW?

REDCap Upgrade and REDCap Support Request Form Updates

REDCap upgraded to v13.7 on November 30th. This version has all of the core functionality from the previous version plus many new features and improvements. You can review a full list of these here.

Updates to the REDCap Support Request Form:

User Rights Request Update – Copy of request
This question will be asked for each user. An email (with a PDF copy) will be sent each time "Yes" is selected.

New Project Request Update – Updated PACE question
Selecting “Yes” will result in a new project being created with the PACE template (see Duke Policy).

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.

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
Phlebotomy Competency for Research	January 3, 2024	1:00 PM
Urine Pregnancy Screening for Research	January 11, 2024	1:00 PM
Workshop: Start Building in REDCap	January 12, 2024	10:00 AM
REDCap: Exporting/Importing and Reports	January 19, 2024	11:00 AM
Urine Pregnancy Screening for Research	January 25, 2024	1:00 PM

CLINICAL RESEARCH EMPLOYEE HIGHLIGHTS

The Orthopaedic Department welcomes:

Jake Ribet, CRC II – Pediatric Division
Mike Isaak, CRC I – Translational Science
Jacob Carpenter, CRS, Sr. – Hand Division

Register your December New Hires for their RPN+ New Hire Cohort!

The deadline to register December new hires for their cohort is 12/31/2023. Any December new hires registered after 12/31 will be placed in a later cohort. The December 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)