The Dispatch Summer 2023

Accelerating the translation of research to the bedside

Table of Contents

1. Message from DCC Leadership
2. Research Spotlight
3. Group Spotlight
4. Business Operations Tip
5. Toolbox Tip
6. What's New in the Workplace?

Message from DCC Leadership

DCC Day 2023 – Awaken the Force: Knowledge lights our way

The DCC Leadership team is excited for our second annual DCC Day located at the Ken Garff Scholarship Club at Rice-Eccles Stadium! This year’s event is on September 6th and features a Star Wars theme, patient panel, and out-of-this-world education, all at a venue ON campus. We look forward to engaging with Dr. Dwyer and other presenters to learn new strategies we can apply to the work we do; accelerating the translation of research to the bedside.

We have the pleasure of working with 14 of your peers who make up the volunteers of the DCC Day Planning Committee. They listened to your feedback from last year and are hard at work developing educational content to help you “...become more powerful than you could possibly imagine” (Obi-Wan Kenobi). Patients and families have also been invited to share their experiences with debilitating diseases and how research has impacted their lives for the better.

The Star Wars theme will pilot us through a dynamic day of training on effective coaching and communication. We will also explore ways to improve the function of all our project teams.

In turn, we hope that you “Always pass on what you have learned” (Yoda).

Join the Alliance to Awaken the Force, reconnect, and celebrate our success! More information will be available on the DCC Intranet portal soon.

Research Spotlight

The Research Spotlight focuses on a program or project that represents a new and interesting research activity.

Paper of the Year

Larry Cook and colleagues won the journal of Injury Epidemiology Paper of the Year award for their manuscript, Accuracy of behavioral health variables in Oregon national violent death reporting system data: a linked cohort study. Using probabilistic linkage, they combined Veteran’s Administration (VA) data with the Oregon Violent Death Reporting System (OVDRS). Results showed the OVDRS consistently underreported behavioral health findings in the VA health record. The OVDRS only identified 49% of descendants diagnosed with depression, 45% diagnosed with post traumatic stress disorder (PTSD), 17% diagnosed with anxiety, and 56% diagnosed with substance abuse disorder. The authors recommend states make efforts to improve the reporting of behavioral health variables to the national system.

The winning paper was selected based on a vote of the journal’s editorial board. The authors will present their work and receive their award at a ceremony at Columbia University in September. The paper can be accessed for free online at the journal’s website.

Please share your Research Spotlight with Monse Lopez to be featured in a future issue.

More Notable Research Updates

• EDC - The EDC is celebrating a press release on behalf of the 2021 National Pediatric Readiness Project (NPRP) assessment results that have been published in JAMA Network Open. The DCC’s Hilary Hewes, MD, Michael Ely, EDC Director, Patricia Schmuhl, EDC Data Manager, Rachel Crady, Biostatistician, Larry Cook, MStat, PhD, are all authors, in addition to our NPRP Co-leads, Katherine Remick, MD and Marianne Gausche-Hill, MD, and Lorah Ludwig with HRSA and the National Pediatric Pandemic Network. Our sincerest gratitude goes out to our collaborative partners ENA, ACEP, AAP, ASC-COT, and the EMSC Program and State Partnership grantees who supported this project to inform ED pediatric readiness quality improvement efforts for years to come. If you have questions about this publication, feel free to reach out to our PedsReady Support Team. The EDC is also facilitating the launch of several new clinical studies for the PECARN Network. Study training for the PEDCAPS study looking at community acquired pneumonia was held this month and enrollment is expected to begin in August. Additionally, the Smart Screen study was funded in the spring and is in the start-up phase. This project is looking at how to improve screening procedures and the identification of teens at risk for HIV in the Emergency Department.
• Care4Kids - The Care4Kids team has been working to increase enrollment. Now all participants have the option to undergo an MRI, compensation was increased, and a report will be sent to parents showing the participant’s results. In addition, we are introducing the Typically Developing Youth Sub-Study that will collect neuropsychological and autonomic data from healthy children to develop normative data.
• CPCCRN - The CPCCRN team has successfully activated all 24 sites in the PRECISE study and enrollment is up to 98 patients. Our goal is to complete study start-up for ancillary studies, and assist our investigators with new grant submissions.
• HEAL - DCC effort in the HEAL Pain Effectiveness Research Network (ERN) has been coined in our NOGA as the Utah Data Coordinating Resource Center (DCRC). We collaborate with the Duke Clinical Coordinating Resource Center (CCRC) and the Johns Hopkins Statistical Coordinating Resource Center (SCRC). Collectively, we serve investigators whose HEAL grants have been funded and need these services. Our Utah DCRC will be awarded a large supplement to add two new Sickle Cell Pain trials to our portfolio of five existing trials, and continue common data element (CDE) work for another year by Kathy Sward and her team. The new sickle cell pain trials will begin the UG3 planning year on September 1.
• Owlet - Owlet receives regulatory clearance for the BabySat: In late 2022, the Utah DCC participated in the design, conduct, analysis, and reporting of a safety trial of the Owlet device. This project marked the first Clinical Study Report (CSR) prepared by the DCC. The Owlet BabySat recently received FDA clearance to market the device, which should be launching later this year. From the Owlet team: “Big thanks to the Utah team for helping us with the CSR. It played a huge role in our submissions!”

Group Spotlight

The Group Spotlight focuses on a group that has new and interesting information to share.

DCC Day Planning

DCC Day 2023 is scheduled for September 6th at the Ken Garff Scholarship Club at Rice-Eccles Stadium. We look forward to meeting and greeting everyone again with an out-of-this-world theme that is sure to delight all, especially Star Wars fans!

This in-person day will include all DCC staff and faculty and should be already blocked out on your calendar. The day will be focused around charting our course, reviewing our strategic initiatives, and talking about what this means to you in your role or specialty area. We look forward to seeing you there!

The DCC Day Planning Committee members are listed below:

Hilary Hickenbotham, Kim Bloom, Spencer Freeman, Christine Mahler, Monse Lopez, Heather Gramse, Erna Serezlic, Marie Kay, Amanda Slater, Liz Rodriguez, Jane Ostler, Adam Mittower, Jan Johnson, and Sally Jo Zuspan.

Please share your Group Spotlight with Monse Lopez to be featured in a future issue.

More Notable Group Updates

Administration

Eden’s Desk Booking just got a major upgrade - hourly Desk Booking is now on web and mobile! DCC users can make reservations for the exact hours they need and free up space for others during the hours they don’t need. All DCC Eden users should start using this functionality, especially if you are using shared office spaces that are limited in quantity. For further details on how to use the hourly desk booking function, or for a refresher on how to use Eden Workplace, please visit the Eden Workplace page on the DCC Intranet portal.

Regulatory Affairs and Quality Assurance

In June, four new SOPs were released. DCC SOPs can be found in the DCC Official Documents eRoom and are accessible to everyone. Please Note: These SOPs are particularly important to Project Managers, Data Managers, and Operations Leaders. The first two below will be of benefit to PMs. The latter two are focused on CDMs.

If you are required to train on these SOPs (see roles below), please complete training as soon as possible, but no later than DCC Day (Sept. 6, 2023). Training link: Start DCC eLearning Self-Learning SOP Trainings

Faculty, Stats, Director/Manager, CDM, and PM roles should complete:

• UU-DCC-SOP-CO-501.00 - Study Monitoring Strategy and Plan
• UU-DCC-SOP-502.00 - Clinical Site Visits

CDM and IT roles should complete:

• UU-DCC-SOP-DM-703.00 - REDCap Project Administration
• UU-DCC-SOP-DM-704.00 - REDCap Operation

LEAD (Learning Education and Development) Program

What? The DCC has new standard resources available in the Utah DCC Learning Hub platform that include training slides and templates, infographics, and eLearning modules. We will continue building upon this resource moving forward. If you have any questions or feedback to share, please contact Marie Kay.

Purpose? To foster consistent messaging and high-quality content provided by Utah DCC staff and faculty (and to help you to not always have to reinvent the wheel).

Where? DCC Official Document eRoom – Education & Training Resources

Who? The content of these standard resources represents a collaborative effort of various staff, faculty, networks, and subject matter experts across the DCC to help ensure a high-quality product. Thank you to those who have collaborated on developing these and also to the Utah TIC for providing funding to support the effort.

Division of Critical Care

Welcome to the new Division of Critical Care Fellows:

• Dawn Maxey, MD
• Medical School: University of California, San Francisco
• Residency: University of Washington
• Undergraduate: Stanford University

• Kathryn Mulligan, MD
• Medical School: University of Iowa
• Residency: University of Seattle
• Undergraduate: University of Kansas

• Nate Hayward, MD
• Medical School: University College Cork School of Medicine
• Residency: University of Utah
• Undergraduate: University of Western Ontario

In Memoriam

It is with great sadness that we announce the passing of Angie Webster. Many of you may remember Angie as a master’s statistician at the DCC. Angie passed away on June 27th, 2023. Angie joined the DCC in 2008 as a Master’s statistician and later, she followed Amy Clark as the Director of the Statistics Team. In 2017, she was diagnosed with cancer and she left the DCC due to her medical issues in 2018. She fought a hard battle for over five years. Angie was a valuable and respected member of the DCC. She was small in stature but was a strong, vocal advocate for the Stats Team and for the DCC, and was an honored leader and friend.

Angie worked on many DCC projects including PECARN, CPCCRN, and NEDARC. She was known for her statistical work but also for helping form the foundation of our current work at the DCC. She initiated training, education, and standards for the Stats Team, and was a strong advocate for consistent approaches across study teams. Angie was soft-spoken but always thinking and planning. She helped grow the DCC by hiring and training many statisticians and worked collaboratively with other groups, investigators, and funders. Angie was reliable, energetic, committed, strategic, sensitive, and considerate. Angie loved working at the DCC and kept in touch with many friends after she left. She was always very interested in the progress and growth of the DCC and kept up on developments and future plans. Several DCC friends visited her in the weeks and days before she died and she continually shared her fond memories and sadness at having to leave the DCC. Angie’s outlook as she battled her disease was constantly optimistic and also realistic. She was never bitter, was thankful for her supporters, friends, and family. She will be sadly missed. Her husband Zach and her family expressed their thanks for those of you who supported her over the last several years and for keeping her as a part of the DCC family.

Angie's obituary provides a meaningful opportunity to honor and remember her life.

Business Operations Tip

The Business Operations Tip section includes useful information about our research operations that can help you conduct your daily operations.

What is a Data Use Agreement and What Do I Need to Know?

Many of you run into the need to navigate the murky waters of obtaining or determining the need for a Data Use Agreement or DUA while managing DCC projects. The process has changed recently so here’s a quick primer on what you need to know:

• Q: What is a Data Use Agreement (DUA)?
• A: A DUA is a formal, contractual document where terms and conditions of data transfer are outlined between the provider of the data and the recipient (DCC).
• Q: Do we have a template to use?
• A: Yes! We use a specifically-designed DCC template. This document is where we start. Sometimes sites have their own and OSP will deal with this scenario for you.
• Q: Why do we need a DUA?
• A: A DUA protects the sender (academic institution, industry) to be sure their data will not be misused. It helps prevent miscommunication by addressing issues up front.
• Q: Do we still use BAAs?
• A: No. Per the University of Utah Office of General Counsel, the DCC DUA should be used in virtually all circumstances.
• Q: Who initiates a review request for a DUA?
• A: Usually a project manager or an Ops Leader (Director, PM IV, Manager).
• Q: How do I start a DUA request?
• A: Contact a PM, or Ops Leader to help. There is a portal set up for this purpose and will guide you through the template language and the process. Go to https://osp.utah.edu/resources/agreement/cda.php.
• Q: Is all this info written down somewhere?
• A: Yes! There is a new Working Guideline that summarizes all this information. It’s under review by OSP and will be available soon.

For other questions related to DUAs at the DCC, please reach out to Sally Jo Zuspan.

Toolbox Tip

The Saga of the Switched Computer

By Cynthia Jones

Picture this: I was going through the security checkpoint at the airport, minding my own business when suddenly, I found myself having to get a pat-down. As I turned around to retrieve my belongings, I spotted my bag, my shoes, and what appeared to be my trusty laptop. Without a second thought, I scooped up all three items, ready to conquer the world. It wasn't until I reached my hotel room, eager to get some work done, that the unthinkable happened—I discovered I had grabbed the wrong laptop! Panic washed over me like a tidal wave. What on earth was I supposed to do? Who should I call? Was I about to face serious consequences? Oh, the horror!

Summoning all my courage, I dialed the airport's number, hoping for a glimmer of hope. The friendly voice on the other end instructed me to fill out a form on the TSA and airport websites and promised that someone would reach out to me within five days. Five days! I could feel my productivity slipping away like sand through my fingers. Not one to give up easily, I immediately contacted my director, sharing the unbelievable turn of events. Our trusty IT department jumped into action, ready to tackle the laptop dilemma head-on. At one point, it seemed like I might have to make a full-fledged police report, but luck was on my side this time.

As fate would have it, the wonderful person who accidentally picked up my laptop realized their mistake. They promptly returned it to the ever-watchful eyes of the TSA, leaving their contact information behind. A twist of fate that had us both laughing at the absurdity of the situation. And so, the morale of this comedic escapade was crystal clear—never, ever assume a laptop is yours without proper verification. To avoid such humorous yet troublesome mix-ups, I learned that adorning your laptop with stickers or labels can work wonders in distinguishing it from the sea of black rectangles. So, my friends, let this tale be a lighthearted reminder to embrace laughter in the face of chaos, and to always double-check your laptop before embarking on an accidental exchange worthy of a comedy sketch. Happy travels and may you never grab the wrong laptop again!

Have a Toolbox Tip to feature in a future issue? Please share your idea with Monse Lopez.

What's New in the Workplace?

Workplace Kudos

DCC Risk Assessment and Risk Management Presented Nationally

Congratulations to John VanBuren, Maryse Brulotte, Larry Cook, Charlie Casper, and Jess Alvey who presented our risk assessment and risk management system at the 2023 Society for Clinical Trials annual meeting in late May in Baltimore. They provided an overview of the regulations, discussed various monitoring techniques (de-risking the protocol, queries, source data monitoring, statistical/visual data monitoring), and a summary on how the individual monitoring components fit into an overall risk-based monitoring strategy. The talk was well attended and sparked conversations among other research organizations implementing risk-based monitoring. This was a terrific opportunity for the DCC to be seen at a national level.

National Work Group on Informed Consent

Jeri Burr has been part of a national work group focused on improving the informed consent process, and the group launched a publicly accessible toolkit in June. The toolkit was presented on the Network Liaison Team call, and a poster was presented at the recent Recruitment Innovation Center Symposium. The toolkit includes tools and resources from across the Trial Innovation Center and Recruitment Innovation Center organizations, as well as global, national, and health literacy resources relevant to informed consent practices and processes. You can download the new toolkit here.

Please share your Workplace Kudos with Monse Lopez to be featured in a future issue.

New Hires

Seeing new faces in your meetings? Make sure to visit the New Employees section of the CRE Intranet to see who has joined our team!

• Lora Bielaga, UU Student IT Intern
• Ryan Bushman, UU Student Biostatistician Intern
• Alma Gamboa Talamantez, Contract IT Project Manager
• Austin Hammer, BI Developer/Analyst
• Divya Pakalapati, BI Developer/Analyst
• Elizabeth Patterson, UU Student Biostatistician Intern

Goodbyes

• Uma Cheziyan, BI Developer/Analyst
• Julianne Ehlers, NEMSIS TAC Clinical Research Director
• Mispah Kwang, Contract Study Site Monitor
• Rick Sauerschell, Contract Study Site Monitor
• Ruby Sexton, Contract Study Site Monitor

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