SHARE:  
Clinical Trials Office Newsletter
June 2024 Edition
We very much welcome your comments and suggestions – please drop us a line with your thoughts at clinicaltrials@rbhs.rutgers.edu.
Research Spotlight:
A multidisciplinary group of researchers has received a $3.1 million grant from the National Institutes of Health (NIH) to study the impact of environmental influences on pregnancy and children’s health.
 
The research project, led at Rutgers Health by Dr. Martin Blaser (CABM,) Dr. Emily Barrett (Rutgers School of Public Health,) Dr. Manny Jimenez (RWJMS,) Dr. Dan Horton (RWJMS) and Dr. Maria Gloria Dominguez (SEBS,) is part of the NIH’s Environmental influences on Child Health Outcomes (ECHO) Program, the largest and most comprehensive national research program focused on enhancing the health of children in the United States. Pregnant participants who are less than 20 weeks from conception are eligible to enroll. The researchers will follow the participants, their partners and children for seven years, tracking factors such as obesity, neurodevelopment, exposure to environmental chemicals and social determinants of health through the collection of biological samples and completion of surveys.
 
With 85 enrolled since the project began earlier this year, the Rutgers Health team is well on their way to recruiting their planned goal of 500 pregnant participants.  Study sites are RWJMS Ob/Gyn clinic and Saint Peter’s University Hospital, both in New Brunswick. 

Congratulations to the Rutgers ECHO team!
Please shoot us an e-mail to clinicaltrials@rbhs.rutgers.edu if you have a new study, grant award or publication from your area that you’d like to share with your fellow RBHS study teams!
NJ ACTS Renewed for Seven Years
The New Jersey Alliance for Clinical and Translational Science (NJ ACTS) has received a 7-year award from the National Institutes of Health under its Clinical and Translational Sciences (CTSA) Program. This award funds the NJ ACTS Hub and provides for the programs and services of NJ ACTS to its affiliates, Rutgers, Princeton University, the New Jersey Institute of Technology and RWJ Barnabas Health. Receipt of this award is an important accomplishment. It means that our programs, including those that support clinical and translational research and science, can evolve seamlessly and without interruption from the initial award (2019-2024) to the new one. These include building additional services for the community, identifying and reducing administrative and regulatory barriers, harnessing AI/ML and informatics resources, creating a genomics research and education service, developing creative training programs, including coordinator badging, and recognizing your work and accomplishments at events, such as the Clinical Trials Day.
 
In addition, the Hub award allows us to compete for key additional programs, including the K12 Career Development Award, the R25 Research Education Grant, and the T32 Pre- and Post-doctoral Training Awards. We will completely celebrate when those are in place as well.
 
The leadership of NJ ACTS thanks you, the entire NJ ACTS research community, for your support and commitment to excellence in research.
Consult with HRPP/IRB Subject Matter Experts!
Virtual Institutional Review Board (IRB) Office Hours
 
DRAFT (Document Revision And Feedback Team) Services hosts IRB Office Hours weekly.
 
When

        Tuesdays, 1:00 – 1:30 pm*
 
        Thursdays, 10:00 – 10:30 am
 
Where:

Virtual 
 
        Office Hours Zoom Link | Passcode: 133269
 
 

The mission of the Document Review and Feedback Team (DRAFT) is to improve IRB submission outcomes by recommending and educating study teams on HRPP/IRB considerations and best practices through pre-reviews and consultations.

*(with IRB Reliance Team)  
 
Clinical and Research Data Warehouse (CRDW)
Rutgers and RWJBarnabas Health researchers may now access the Rutgers Clinical and Research Data Warehouse (CRDW,) which combines healthcare data from sources that include Electronic Medical Records (EMRs), Centers for Medicare & Medicaid Services (CMS), Tumor Registries, Biospecimen Repositories, and medical imaging and genomics repositories.
 
The CRDW is planning to host workshops for researchers starting in August. Stay tuned for more details! In the meanwhile, visit the CRDW website for more information on the data available, fees and links to request datasets.
Regulatory Tip of the Month:
Office for Research Launches New Website
The Office for Research is proud to announce the launch of their new website at research.rutgers.edu. Using feedback provided by faculty and research leaders from all four Chancellor-led units, the website's new architecture makes critical information easier to find. The new website includes a resource library, easy-to-access tools, documents, and research compliance information. A second phase launch, which will include further improvements and features is currently in development, so stay tuned! 
Upcoming Events
Innovations in action: Leveraging the Epic platform to accelerate patient-centric recruitment and improve representation
Monday, July 1st, 2024
12:00 pm
Nancy Smider & Tom Yosick
Electronic health records (EHRs) are a ubiquitous component of the technology landscape for healthcare. Epic is an EHR platform that has a strong commitment to innovation through iterative collaboration with our community of stakeholders. This community includes organizations using our software, patient/participant/consumer advisory groups, consortia and workgroups focused on a range of aspects of clinical research and trials, as well as our own teams. In this presentation we’ll share some of the ways our platform has effectively accelerated recruitment and enhanced representation and retention in clinical trials. Both past successes and new opportunities to impact the trial landscape will be discussed.
NJMS Clinical Research Work Group Call
Monday, July 22nd, 2024
12:00 pm
We are back with our first NJMS Clinical Research Work Group of 2024. Our agenda for this meeting will be:

What to know about the new Epic research functionality coming to UH-Newark.

More information will be sent closer to the meeting date.
NJMS Corner
Epic Research functionality to go live at UH-Newark on December 1st
The Epic Resolute Project goes live December 1st with the Research module. This will allow Epic to integrate clinical care and research to improve the patient experience, optimize patient care, and enhance operational research efficiency.
 
This new functionality will help study teams to:

Empower Patients: In MyChart, patients can indicate their desire to be contacted about potential research studies. They can also review details about studies they’ve participated in or might be eligible for.
Keep Research Studies Organized: Information such as the study status, NCT number, IRB approval number, and key staff members can be found all in one place.
Track Participant Accrual Process: Study teams can monitor their progress towards participant accrual targets and timelines on a dashboard.
Inform Clinical Staff: Non-research providers can see an indicator on the patient's chart with information about research studies the patient is participating in, allowing them to follow up with questions or concerns about the patient's participation.
Record Adverse Events: Study teams can document and track adverse events.
Support External Monitors: EpicCare Link enables external monitors to access a read-only chart to review source data in Epic for specific patients associated with the study they are monitoring.
Stay Research Billing Compliant: Adjudicate research-related charges and automate NCT number, condition codes, and appropriate modifiers onto the claim to reduce the manual per-patient effort required to ensure compliant billing.
Link Orders and Encounters: Link appropriate encounters and orders to the research study they are associated with. This allows for reporting, quick research billing review, and promotes research-aware patient care.
 
Be sure to attend the July 22nd NJMS Clinical Research Workgroup call to learn more. Training will be required for all NJMS study coordinators with Epic access, so look out for the training schedule and tip-sheets leading up to go-live.   
RWJMS Corner
Regulatory Workshop
Clinical Research Pet of the Month
June's clinical research pet of the month is Oreo. Oreo's pet parent is Veenat Parmar from the Rutgers University Microbiome Program.

Oreo was galloping along one evening with a collar and broken leash attached to him. Veenat noticed a dog on the street and told her brother to stop the car. Oreo was out of breath in the hot summer month of August 2018. Veenat and her family made many attempts to locate Oreo's original family from social media posts, to involving the authorities, but to no avail. Since he wasn't microchipped, and no one claimed him, Oreo soon found his new home with the Parmar family.

Oreo enjoys chicken and fish flavored treats, long walks, frequent belly rubs, and cuddles before bed.

Oreo is not a fan of baths, heat waves, and new people.

Oreo's most proud attribute is his ability to prance like a true show dog. He also has a characteristic bark known as a "blep". If you want Oreo's attention, all it takes is the savory aroma of a freshly roasted chicken to awaken him from a nap or a long slumber.
Congratulations Oreo and Veenat!
If you want your favorite pet featured in the next newsletter, reach out to us via clinicaltrials@rbhs.rutgers.edu