Dr. Suchismita Ray, Associate Professor, School of Health Professions is currently leading two NIH-funded clinical trials focused on understanding and improving treatments for opioid use disorder (OUD) and alcohol use disorder (AUD).

Her primary project, an R61/R33 grant from NIDA (09/2024–08/2029; $3.18M, Contact PI), is a multi-phase clinical trial investigating the efficacy of guanfacine extended release (GXR) and Mindfulness-Oriented Recovery Enhancement (MORE)—independently and in combination—in individuals with OUD who are maintained on buprenorphine. The R61 phase evaluates whether GXR, MORE, or their combination can reduce opioid craving, stress, anxiety, and reward-driven reactivity during laboratory stress and cue-provocation tasks, with the combined intervention expected to yield the strongest effects. In the R33 phase, the study examines how these interventions influence brain activation and connectivity related to stress- and cue-induced craving using functional MRI to identify regulatory, affective, and reward-salience neural mechanisms.

In parallel, Dr. Ray serves as Site PI on an NIH/NIAAA-funded R01 study (approx. $1.41M), a 12‑week clinical trial evaluating GXR in individuals with AUD. This project examines whether GXR versus placebo reduces drinking severity through weekly biological and self-report assessments and tests whether GXR can attenuate stress-induced alcohol craving and real-world drinking behavior using ecological momentary assessment.



Across these studies, Dr. Ray and her collaborators aim to establish the clinical efficacy of GXR and mechanistic behavioral interventions like MORE, while also elucidating the underlying neural pathways involved in stress and cue reactivity in substance use disorders.

Congratulations Dr. Ray!

Dr. Suchismita Ray (Ph.D.)

Principal Investigator

Raquel Mack, M.S.

Research Assistant

Sarah Berger, M.S.

Clinical Trial Coordinator

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!

Paul Harris, PhD, Professor,

Director Biomedical Informatics

Details to be announced

Starting January 1st, all new industry-funded registry or phase IV/post-marketing studies are required to be in OnCore, irrespective of whether there are billable clinical procedures entailed with the study or not. This change has been made at the request of Rutgers Health leadership to more comprehensively track clinical research productivity and our industry sponsor relationships. (Previously, use of OnCore for such studies was considered optional.) Note that the specific build of the study in OnCore will depend on whether the study has billing implications and whether participant visit tracking is required for the purposes of sponsor invoicing or not. 

The new criteria for when entry into OnCore is required are as follows:

• All industry sponsored/funded clinical research studies
• All clinical trials (as defined by NIH)
• All studies entailing billable clinical procedures that may be either/or
• billed to study budget requiring Epic charge review
• billable to patient insurance requiring Epic claims codes/modifiers



As always, please contact the CTO at clinicaltrails@rbhs.rutgers.edu with any questions about this change or to discuss any specific studies.

Over the past few years, a team consisting of representatives from Rutgers HRPP and the Office of General Counsel have met with key stakeholders at RWJBH to develop mutual guidelines for recruitment and screening of research participants. As part of this process, a standard operating procedure has been developed to provide guidance as to when a Partial HIPAA Waiver for Screening and Recruitment is required. Click here for a copy of this document. 

In short, IRB administrators will begin to assure that an investigator has applied for this type of waiver of HIPAA authorization in the event that a study team member (who is not a member of the clinical care team) wishes to view a patient’s PHI for the purposes of screening and recruitment in advance of a participant signing the study consent and HIPAA authorization. Rutgers HRPP is in the process of developing guidance materials for their website and instructional text to insert in the eIRB application. Watch out for more information on this topic in the upcoming months. 

You can find OnCore notes by clicking on the note icon in the top left corner of PC console. If no icon is present, a note has not been created yet. Alternatively, they can be found in Documents/Info -> Archive/Notes.

OnCore notes is updated in real time by the CTO team as progress is made in terms of calendar builds and budget/contract negotiations. All OnCore users should have access to notes.

Please shoot us an e-mail at clinicaltrials@rbhs.rutgers.edu with any questions about specific startup activities or access issues.

In case you missed it, the reporting threshold for IRS Form 1099-MISC (which clinical research participant payment income is reported on) was raised from $600 to $2000, effective 1/1/26. Note also that beginning in tax year 2027, the $2,000 threshold will be adjusted annually for inflation.

For studies using Greenphire Patient Payments, new consent language (which also incorporates the recent branding and company name changes) is available on the Rutgers HRPP toolkit. Spanish translations of these documents will be posted soon, however, if you need them immediately, please email us at clinicaltrials@rbhs.rutgers.edu.

Click here for a copy of the guidance that was sent out on 1/9/2026.

The CTO launched a new portal in 2025 to streamline common requests. We updated some language on the request types to make it clearer for end users.

For new accounts / access request on our software platforms like OnCore, Deep 6 or ClinCard: "Account Access Request"

To add a missing study sponsor, PI, Sub-I, or other research staff in OnCore: "Missing OnCore Sponsor or Study Staff Member"

The request portal can be accessed here.

Deep 6 AI Cohort Builder coming to UH-Newark!



Deep6 AI Cohort Builder is scheduled to go-live with UH-Newark’s instance of Epic this Spring. Watch for more information as we get closer to the date about how to request a query to determine whether a study is feasible from a recruitment standpoint and how to request training to use this software as a recruitment tool. Click here for more information about using Deep6.

An upcoming enhancement is planned to the RWJBH Epic Research Charge Review process to improve accuracy, compliance, and efficiency of resolving research charges. Starting next month, the RWJBH Research & Billing Review (RBR) team will begin incorporating an additional step of verification of charges, after the study team performs the initial review of charges in Epic and prior to releasing the charges to the hospital revenue cycle teams.

This change should not substantially change or add to the study team’s obligations, but it will entail a shift in how the RWJBH RBR team, the study teams, and the CTO communicate and resolve pending charges, which will rely on the study team’s OnCore documentation. In the coming weeks, the CTO and RBR teams will schedule a demonstration and training session to ensure all parties are in alignment. This will be recorded and made available to any that are unable to attend.

Once implemented, this collaborative effort will enable a smoother and more effective process for both organizations to close out insurance claims, sponsor payments, and generate invoices. We look forward to your cooperation and continued commitment to compliance‑focused, high‑quality clinical research operations.

For questions regarding this process change, please contact:

OnCore Support: clinicaltrials@rbhs.rutgers.edu

Research Billing Support: Epic Help Desk

Clinical Research Pet of the Month

February's clinical research pet of the month Is Hurley, a 4-year-old Golden Retriever. His dog mom is Judy Argon, Executive Lead for Program Development for NJ ACTS.

Judy and her family adopted Hurley at the tender age of 8 weeks. As a now grown-up, he is an incredibly social dog who assumes that everyone wants to pet him. When Judy is walking him and he sees people a block away, he lies down and waits for them to reach them, so they get a chance to give him belly rubs. Like most Goldens, Hurley is a Velcro dog. He loves attacking his stuffies and pulling out the insides and killing the squeaker!  

Congratulations to Hurley and Judy!

If you want your favorite pet featured in the next newsletter, reach out to us via clinicaltrials@rbhs.rutgers.edu

We very much welcome your comments and suggestions – please drop us a line with your thoughts at clinicaltrials@rbhs.rutgers.edu.