Our previously published newsletters are available on our website. You can find them here.
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The Maternal-Fetal Medicine Divisions of Rutgers Robert Wood Johnson Medical School (RWJMS) and New Jersey Medical School (NJMS) participate in The Perinatal Research Consortium (PRC), a collaborative formed in 2005 to conduct prospective observational studies and clinical trials. The PRC consists of 10 member institutions with twelve maternity hospitals, which collectively, delivers 45,000 women annually. The PRC has a single institutional review board and master sub-award agreements which are essential for NIH-funded research and also facilitates industry collaborations. Dr. Shauna Williams serves as the principal investigator for the PRC in Newark, and Dr. Todd Rosen serves as the principal investigator in New Brunswick.
The PRC has participated in numerous NIH-funded studies including the Chronic Hypertension and Pregnancy Project (CHAP) and the Medical Optimization of Management of Overt Diabetes in Pregnancy Study (MOMPOD).
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The CHAP study was a randomized controlled trial of pregnant patients with mild chronic hypertension in pregnancy to either active treatment with a blood pressure goal <140/90 mm Hg (n = 1,208) versus control (n = 1,200). Despite recruitment challenges due to the pandemic, and challenges inherent in recruiting pregnant women, Rutgers RWJMS and Rutgers NJMS enrolled 44 patients. Study results showed that, among pregnant women with mild chronic hypertension, antihypertensive therapy targeted to a blood pressure <140/90 mm Hg reduced the incidence of important adverse pregnancy outcomes compared with standard of care. Study results were published in the New England Journal of Medicine in May of 2022, which led to changes in the current guidelines for managing hypertension in pregnancy.
The MOMPOD study, which was completed more recently, was a randomized controlled trial of pregnant patients with Type II Diabetes to 1000 mg of metformin BID vs. placebo, plus insulin. The primary outcome was a (composite) of perinatal mortality, preterm delivery; neonatal hypoglycemia, hyperbilirubinemia, pH < 7.0, shoulder dystocia with injury; large for gestational age (LGA) or small for gestational (SGA), or low birth weight (LBW) infant. The DSMB stopped the study at 830 participants due to futility for primary outcome without short-term safety concerns. Adding metformin to insulin to treat type II diabetes in pregnancy did not reduce composite adverse neonatal outcome, reduce maternal hypoglycemia, or infant fat mass. Metformin was found to reduce the frequency of a (LGA) infant without effecting mode of delivery. Additional studies are needed to measure long term infant metabolic outcomes. The manuscript is still in preparation, and we hope it will be published in a high impact journal. Rutgers RWJMS and Rutgers NJMS enrolled 31 patients.
The manuscript is in preparation. Together, Rutgers RWJMS and Rutgers NJMS enrolled 31 patients into this study.
Congratulations to Drs. Rosen and Williams and the RWJMS and NJMS study teams on this successful cross-medical school collaboration!
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Top to bottom: RWJMS study team: Andrea Prada, Shama Kahn, Vanessa Martinez and Todd Rosen, MD; NJMS Study team: Yanille Taveras & Shauna Williams, MD
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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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Regulatory Tip of the Month |
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From the Rutgers IRB: A new infographic on Reportable Events |
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RBHS Clinical
Research Workgroup
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Barbara DeMarco, PhD, Senior Associate Dean for Education, and Director, Rutgers Biopharma Educational Initiative will be our guest speaker. The topic will be the new CRC badging program! |
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The Human Research Protections Program (HRPP) is offering a Reliance workshop on Thursday, April 27 from 12:00 pm-1:00 pm. The session will focus on understanding the IRB Reliance Mechanisms. Researchers, faculty and students are invited to learn more about our streamlined reliance processes for Single IRB (sIRB) and Administrative Review submissions to the IRB. |
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ACRP 2023 is the place to be for clinical research professionals seeking inspiration, information, and connection.
Sheraton Dallas / April 28 - May 1
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The Zoom event begins at 6:30 PM EDT on Wednesday, May 10th.
This event is free to NY Metropolitan Chapter members and ACRP Consortium Chapter Members and $25 to all others. You may pay via credit/debit card by clicking on the PayPal link. There is no need to have a PayPal account. Alternatively, you may join our chapter for $25 annual dues and enjoy free evening educational events and discounted symposium fees. We hope to see you there!
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EPIC Billing Review Tip Sheet
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- Find patients needing research billing review
- Transfer a charge from the study account to the patient's account
- Mark charges as reviewed
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UH-Newark created a mechanism to request reports from the EMR for all purposes, including clinical research. The form can be found here. Click here for an FAQ document about the process.
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How do I update OnCore to reflect a change in PI? |
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Please see our January edition of our newsletter for regulatory instructions. This tip is ONLY for specific instructions on how to document a PI change in OnCore PC console. First thing you will want to do is put the study on hold and list the reason as PI left and fill out the context of the situation in the comments text field. This is located in PC Console > Status. When the new PI has started, you will change the status from on hold to off hold and again in the comments list that a new PI was added.
On Hold - This status is typically assigned when a sponsor puts the protocol on hold prior to opening to accrual.
- The On Hold button is displayed until the protocol status becomes Open to Accrual.
- The Off Hold button is displayed when a protocol is On Hold.
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When a protocol is removed from On Hold status by clicking Off Hold, the protocol reverts to its previous status. In this way, the Off Hold status undoes the On Hold status (and vice versa), so other functionality to undo the status change isn't available for these statuses.
- When an approved Initial IRB Review or an approved Initial PRMC Review is entered for a protocol having the status On Hold, OnCore updates the status of the protocol to IRB Initial Approval or PRMC Approval and inserts an Off Hold status into the table.
An Undo On Hold button appears for protocols in On Hold status, and an Undo Off Hold button appears for protocols with an Off Hold status. Clicking either button reverses the protocol status to its previous state. Note that to access these buttons, you must have the Protocol > On Hold and Protocol > Off Hold permissions.
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Second, you will want to take the old PI off the staff list by putting an end date to their staff role and listing the stop reason as PI left. The PC Console > Main > Staff tab is where staff members associated with the protocol are managed. Subsequently, you will add the new PI to the staff list and list them as active as of the date they were contractually assigned as PI in the CTA. Staff change instructions can be found below:
Start Date
Appears only if the Active Staff Only checkbox is cleared or if you are editing staff in the edit window.
An optional field indicating the date that a staff member is considered 'Active' on the protocol. For permissions having a scope of 'Assigned', an entry here will preclude access until that date.
Stop Date
Appears only if the Active Staff Only checkbox is cleared or if you are editing staff in the edit window.
An optional field indicating the final date after which a staff member is no longer considered active on the protocol. For permissions having a scope of 'Assigned', an entry here prevents access beyond that date, and it prevents the staff member from continuing to receive any role-based notifications for the protocol.
Reason/Stop Reason
Appears only if the Active Staff Only checkbox is cleared or if you are editing staff in the edit window.
The reason a Stop Date has been entered. This is an information-only field and does not drive any OnCore functionality.
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Clinical Research Pet of the Month |
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April's Clinical Research Pet of the Month is Mochi! Mochi's human is Carmen Kathera-Ibarra, clinical research manager at RWJMS Cardiology!
Despite Mochi's new digs on the East Coast, she remains the ultimate sun-loving pooch from San Diego! With her sandy fur and infectious grin, Mochi is always ready for a day of tanning and napping under the bright California sun. At six years old, this furry diva knows how to kick back and relax in style.
Whether she's lounging by the pool or dozing in the shade, Mochi is always the life of the party. So if you're looking for a furry friend who knows how to soak up the rays and have a good time, look no further than Mochi!
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