Research Spotlight:
STOMP Study
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Research with a Heart (RWAH) at NJMS is actively recruiting for “STOMP,” the phase 3, double-blinded, randomized, placebo-controlled clinical trial to evaluate the efficacy of Tecovirimat as treatment for Human Monkeypox virus infection (Mpox). The study is funded by the National Institute of Allergy and Infectious Diseases (NIAID) and led by the Advancing Clinical Therapeutics Globally in HIV and other Infectious Diseases Network (ACTG). STOMP opened to enrollment in the fall of 2022 with an enrollment goal of 530 participants. Currently, the study has enrolled a diverse cohort of almost 300 individuals across 80 sites throughout the US. “Unfortunately, we are still seeing cases of Mpox locally, nationally and globally. We are very excited to be participating in this study, and we hope this study will help answer whether the investigational agent Tecovirimat (TPOXX) is truly effective and safe in treating Mpox,” says PI Debra Chew, MD, MPH.
Participants are followed for about 8 weeks and those with severe disease, or at high risk for developing severe disease (including children, pregnant and breastfeeding people and those with underlying immune deficiency and active inflammatory skin conditions), can receive tecovirimat through an open label arm of the study. STOMP also allows individuals unable to present in person to a research site to enroll remotely and receive study treatment through a courier service. This inclusion and flexibility helps ensure that all potential candidates can access this very important study.
RWAH remains steadfast in their commitment to Elevate Everyone and Rehumanize Research, engaging diverse communities to ensure equitable and inclusive access to groundbreaking research opportunities. Visit www.stomptpoxx.org for more information on the STOMP study and https://linktr.ee/researchwithaheart to connect with RWAH!
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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!
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Rutgers ClinCard Visa Program to launch on March 1st |
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Please join us for either of the two webinars below to learn about important changes and program enhancements that will impact all ClinCard users. Please note that you will have to download, open, and save the ics file to add the meeting to your outlook calendar.
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Thursday, February 29, 2024
12:00 pm to 1:00 pm
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Thursday, March 7th, 2024
3:00 pm to 4:00 pm
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Recruitment Innovation Center Community of Practice |
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Would you like the opportunity to engage with clinical research professionals at other top universities across the country to share best practices for recruiting and retaining participants on clinical trials? As an employee at a CTSA hub, you have an opportunity to do just that! The Recruitment Innovation Center Community of Practice (RIC CoP) (formerly known at the CTSA Recruitment and Retention Working Group) provides a forum for study teams across the US to learn from one another about timely topics in research recruitment and retention such as leveraging Epic tools and community engagement.
All that it takes to join this community is to complete a brief form to get an account.
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Regulatory Tip of the Month |
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What is a Certificate of Confidentiality? |
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A CoC is a certificate issued by the NIH as part of a policy that was enacted in 2017 that prohibits the disclosure of research participants’ identifiable, sensitive data to anyone not connected to the research. Studies that are NIH-funded are automatically issued a CoC, while non-NIH-funded studies have the option to leverage these protections by request.
While this level of privacy may sound redundant to The Belmont Report or HIPAA policies, these protections were enacted specifically to mandate that the data is immune from the legal process and is not admissible as evidence in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings in perpetuity, unless the participant consents to disclosure. For more information about ICF template language, which kinds of data are protected, and investigator/sponsor responsibilities, check out these links.
https://research.rutgers.edu/faculty-staff/compliance/human-research-protection/hrpp-guidance-topics
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Congratulations to Fei Chen on her new role as RWJMS Adult CRC Nurse Manager! |
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Fei recently accepted her new leadership role in the CRC, where she has been working as a research nurse since 2007. She is well known at RWJMS for her dedication to clinical research and for her hard work. She has a reputation as a stellar recruiter with a “can-do” attitude that is second to none.
Fei has been working in clinical research since 2001, with an accomplished career prior to that in various intensive and acute care hospital settings. Throughout her years at RWJMS, she distinguished herself by taking on the most difficult and complex inpatient studies and succeeding at them beyond all expectations. With these skills, we have no doubt that Fei will take the ACRC to new heights. Please join us in warmly congratulating Fei on her well-deserved promotion and wishing her the very best.
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Wednesday, February 21st, 2024
12:00 pm
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This presentation will cover the CAN-DO-IT model (Macapagal et al, 2020) as applied to recruitment and retention of sexual and gender minorities into research, with a focus on community-based and social media/online recruitment. This flexible framework consists of 7 iterative steps based on work by our team and others: conceptualize scope of recruitment campaign, acquire necessary expertise, navigate online platforms, develop advertisements, optimize recruitment-to-enrollment workflow, implement advertising campaign, and track performance of campaigns and respond accordingly.
We have used this approach in cross-sectional and longitudinal studies, dyadic studies, and in-person and virtual research studies with adolescents and adults with various budgets. Participants should take away different concrete strategies that they can apply to their clinical research to diversify recruitment and retention and increase representation of sexual and gender minorities, but the strategies should apply to many different types of populations.
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Interested in using Epic for Research Recruitment? |
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You can submit a ServiceNow ticket for research data and recruitment requests in Epic. Services such as SlicerDicer, MyChart, and reports can be used to assist study teams during recruitment. A tip sheet to assist you in navigating these requests can be found here.
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Revamping the OCRA receipt process for CTO Studies |
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In pursuit of our mission to streamline processes and increase efficiency, the CTO, UH-Newark, and the Rutgers’ IRB have agreed to revamp the OCRA Receipt process, specifically for studies that fall under the purview of the CTO/meet OnCore criteria*
The goal of this change is two-fold: (1) to eliminate redundant steps by incorporating the notification to UH and the IRB into existing workflows and (2) to allow the initiation of IRB applications and UH facility use agreements earlier in the study startup process, which we hope will ultimately decrease study startup timelines.
At present, one of the main components of the OCRA Receipt is the Proposed Billing Plan, which takes time to develop and is contingent upon completion of a Medicare Coverage Analysis. Going forward, the CTO will instead utilize the Administrative SRB Approval notification (via OnCore) as the mechanism to (1) notify and provide basic study information to UH and (2) provide proof of UH awareness to the IRB (for Section 5.0 of eIRB). Additionally, the new Billing Plan Proposal that will follow the SRB Approval will also free up UH CRS (Arleen Wallen and Eduardo Torres) to prepare for UH leadership approval more efficiently.
Note that these changes are on the “back end” and do not require any changes on behalf of the study team. Study teams will continue to submit their studies to the CTO in the usual manner through OnCore ePRMS. Also please note that the OCRA Receipt process will remain unchanged for retrospective chart reviews and other non-CTO studies.
*All Rutgers Health clinical trials and prospective, observational studies are required to be in OnCore. For more information, please visit our website.
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How to document Additional Visits in Subject Console |
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At times, subjects will be seen for visits that are not on the standard schedule. These visits can be recorded via the Additional Visits tab. Clicking New on the Additional Visits tab displays a Subject Visit Update page where visit details can be entered. Users must have the Subject > Subject Visit Update permission to add or update additional visits. |
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After a Visit Date is entered and the Submit button clicked, an Additional Procedures button appears at the bottom of the page. Only procedures selected from the Protocol Procedures tab have the ability to have Forms associated with them. When the forms are displayed on the Forms by Status > To Do Forms tab, the visit will be named ‘Additional’.
Additional visits do not appear on the subject calendar. Additional visits cannot be deleted once placed on an invoice, even if that invoice has been voided.
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Clinical Research Pets of the Month |
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February's clinical research pets of the month are two special felines by the names of Jacey and Mochi! Their pet parent is Jennifer Punsal, Regulatory Manager for NJMS Research with a Heart. Jacey is a 2-year-old silver tabby and Mochi is a 9-month-old tortie.
Mochi and Jacey bring so much joy to the heart of their cozy home. Mochi is a whirlwind of kitten energy, always curious and full of antics that never fail to make their owners smile. She's a pro at sophisticated cat tricks, from learning to sit on command to perching on their owner’s shoulder for a cat treat.
Jacey, on the other hand, exudes a calm and comforting presence. If you’re feeling down or under the weather, Jacey will curl up next to you, ensuring you are safe and comfortable. While Mochi loves indoor adventures, Jacey finds peace and happiness exploring the great outdoors, hopping into her wagon for a ride. Mochi's playful spirit and Jacey's serene nature create a perfect harmony, making every day a delightful mix of excitement and tranquility.
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Congratulations Jennifer, Jacey, and Mochi! |
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