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Clinical Trials Office Newsletter
October 2026 Edition
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Study Spotlight:
Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and/or Diabetes (MOM-HD)
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Hypertensive disorders during pregnancy and gestational diabetes are among the leading causes of maternal and fetal morbidity and death worldwide. Managing these conditions requires frequent blood pressure and blood glucose monitoring. In low-resource settings like Nepal, however, logistical barriers make regular clinic visits difficult, leaving many women at risk of poorly controlled readings and serious complications. This study evaluates whether a mobile app-based telemonitoring program can bridge this gap by allowing pregnant women to monitor their vitals at home and share results with their care team in real time.
The goal is to enroll 864 pregnant women aged 18 and older who are diagnosed with hypertensive disorder of pregnancy or gestational diabetes in this NIH-funded study, at one of the study's three designated metropolitan hospitals in Nepal. Enrolled participants are randomly assigned either to the MOM-HD program plus standard care, or to standard care alone, and are followed from enrollment through six weeks postpartum. Those in the MOM-HD group receive a blood pressure monitor and/or glucometer, along with a mobile app that automatically sends their daily readings to a provider-facing portal so their care team can review them in real time. The app also gives participants automated feedback on whether their readings fall within clinically recommended ranges, alongside biweekly check-in calls with a study nurse. The study hypothesizes that the program will reduce adverse outcomes for both mothers and newborns by enabling timely clinical decision-making during this critical window.
Beyond testing clinical effectiveness, the study is also evaluating how well the MOM-HD program works in real-world settings, including its cost-effectiveness and sustainability. Using the RE-AIM (“Reach – Effectiveness – Adoption – Implementation – Maintenance”) framework to assess sustainability of the intervention. Together, these findings will help determine whether the program is not just effective, but affordable and scalable for rollout.
The study is actively recruiting participants.
Congratulations, Dr. Rawal and team for launching this important study!
| | 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 Rutgers Health study teams! | | Automated, real time, EHR data abstraction for multi-center trials: REDCap and the MODEM trial experience | | |
Wednesday, October 21st, 2026
12:00 pm
| | In his presentation, Dr. Seitz will discuss the options currently available for de-identified data collection in EHR-enabled, multi-center trials and their limitations. He will introduce the REDCap tools capable of automated, real-time, EHR data abstraction and de-identification. He will describe how these REDCap tools are being used in the ongoing MODEM Trial. He will also highlight barriers and challenges encountered during the trial and the solutions the MODEM trial team are using to address them. | | Rutgers University Genetics Coordinating Center: How we run online genetics studies | | |
Monday, November 2nd, 2026
12:00 pm
| | Tara Matise Ph.D. & Steve Buyske, Ph.D. | | The Rutgers University Genetics Coordinating Study is conducting research studies on the genetics of breast cancer, blood cancer, kidney diseases, and pulmonary hypertension. These studies are conducted online, involve surveys and saliva collection, and provide an ancestry report as a small incentive. We will describe our study design and recruitment approaches, which have led to the enrollment of over 16,000 study participants to date. | | Do you have a Site Initiation Visit (SIV) scheduled? | | If so, please email the CTO at clinicaltrials@rbhs.rutgers.edu so we can help assure that the study start up activities the CTO is responsible for have been accomplished. | | Advance Your Clinical Trial Leadership— NJ ACTS Principal Investigator Badge Pilot Enrollment Now Open until Oct 13th | | |
Are you a clinician or clinical researcher who currently leads—or plans to lead—clinical trials?
The New Jersey Alliance for Clinical & Translational Science (NJ ACTS) Workforce Development Core invites you to join the Principal Investigator (PI) Badge pilot program at no cost. The standard $80 enrollment fee will be waived for pilot participants.
The Principal Investigator Digital Badge is an eight-module, fully online, self-paced program that typically requires 16–20 hours to complete. Through interactive case studies, branching simulations, and real FDA Warning Letters, participants will develop practical skills in:
1. Good Clinical Practice and regulatory compliance
2. Ethical leadership and participant safety
3. Protocol oversight and data integrity
4. Research team supervision
5. PI decision-making and inspection readiness
The curriculum aligns with Quality Matters, Joint Task Force Core Competencies, ICH E6(R3), FDA Form 1572, and the Declaration of Helsinki.
A current CITI Program Good Clinical Practice certification completed within the past two years is required. Space is limited.
Please complete the PI Badge pilot interest form here by Tuesday, October 13th to participate:
Register for the PI Badge Pilot Program
Your participation and feedback will help strengthen this program for future investigators. We hope you will join us!
For questions, please contact Yasheca Ebanks, NJ ACTS Program Manager, at yebanks@rutgers.edu.
| | OnCore Account Inactivity Deactivation | | To help strengthen data security, OnCore accounts will automatically be deactivated after 90 days of inactivity. Users whose accounts are deactivated due to non-use will receive an email notification. To reactivate your account, please contact the Clinical Trials Office. Please note that eReg access is not affected at this time and will continue to function even if your OnCore account has been deactivated. | | |
Message from Rutgers HRPP: New eIRB+ Enhancement Will Streamline Making Personnel Updates
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The Office for Research is pleased to share an upcoming enhancement to the eIRB+ application that will make eligible study team personnel changes faster and easier to process.
Currently, adding or updating many Rutgers study personnel in the eIRB+ requires submission of a modification that undergoes IRB review. Launching Oct. 5, the new Automated Personnel Change Modification option will allow eligible personnel updates. The automated process will perform system checks to confirm required compliance requirements, including CITI training and eCOI+ disclosure status, and provide immediate determination for qualifying requests. This enhancement will be available for both exempt and non-exempt studies and is expected to streamline thousands of personnel updates annually.
The automated process will be available only for eligible Rutgers study personnel changes, such as:
· Rutgers Co-Investigators
· New Rutgers Study Coordinators
· Rutgers Research Staff
The new submission type will not be available for:
· Principal Investigator changes
· Non-Rutgers personnel
· Research site changes
· Other study modifications
Want to learn more after the launch? Explore eIRB Quick Guides for details about the Automated Personnel Change Modification process and key features of the eIRB+ system.
| | Resources available through the CTSA Trial Innovation Network | | Just a reminder that, as a CTSA Hub, Rutgers clinical research teams have access to the CTSA Trial Innovation Network (TIN) website where other CTSA hubs from across the country share resources and tools to conduct clinical trials. Among many other resources, you’ll find recruitment tools, publications, links to past webinars, etc. The TIN also provides free consultations for investigators who are writing grants to conduct multi-center trials. | | Reminder: Please upload relevant RWJBH Partner Hospital documents to OnCore as early as possible | | Please remember to upload copies of partner hospital documents such as the IRC application, IRC approval letter, IT&S approval letter, radiation safety approval letter as soon as these documents are available. These documents are necessary for the CTO to draft the covered study agreement between RU and RWJBH. Please upload to PC Console -> Documents Tab as screenshotted below. | | |
Clinical Research Pets of the Month
| | October's clinical research pets of the month are Ada, Riley, and Malu. Their pet parent is Guadalupe Astorga, PhD, research specialist within the Infectious Disease Division at NJMS. | | |
Ada, AKA Flufface
Ada is an adventurous little personality with a serious love for the outdoors. She enjoys hiking, swimming, and running after her ball, but her greatest passion is carrying sticks that are hilariously bigger than she is. She also has very clear opinions and knows exactly how to communicate them: a gentle paw tap followed by an intense stare until her wishes are fulfilled. And when it comes to her elephant toy, she can get… particularly enthusiastic.
Riley, AKA Mr. Boy
Riley was more recently adopted, so his early story remains a mystery. He has a bit of an anxious attachment style and a charming combination of professor energy and little-boy sweetness.
He isn’t interested in toys and would much rather spend his day quietly keeping you company. Going outside is one of his favorite things. His relationship with food is more complicated: he has little interest in his own meal but becomes extremely motivated when the food belongs to someone else—or happens to be in the trash.
Malu, AKA Maria Luiza
Malu takes her toys very seriously and has always been enthusiastic about food, especially chicken crunchies. Her enthusiasm was a little excessive, though, so her parents switched her to lamb to discourage her from requesting snacks every hour. She still enjoys sniffing the grass, but has now retired from her former energetic lifestyle and devoted herself to napping and lounging in her bed, where she rolls while playing with her ears. And, of course, her adorable little tongue is almost always making an appearance.
| | Congratulations to Guadalupe, Ada, Riley, and Malu! | | | | |
