October 2022 Edition
Our previously published newsletters are available on our website. You can find them here.

We very much welcome your comments and suggestions – please drop us a line with your thoughts at clinicaltrials@rbhs.rutgers.edu.
Announcing the Clinical and Research Data Warehouse, a new tool for Rutgers researchers to access RWJBH clinical data and more. Click on the image below to learn more!  
Hello, RBHS study teams: Here is the first installment of a regular new feature for our website and our newsletter. Each month, we plan to highlight a new interesting or exciting research project at RBHS. 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!
Research Spotlight: EXIT-CJS
Research with a Heart at NJMS and University Correctional Health Care at RWJMS are conducting “EXIT-CJS (Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults.)” Dr. Amesika Nyaku and Dr. Donald (Rusty) Reeves, MD are the PIs for this study, which is funded by the National Institute on Drug Abuse (NIDA) and sponsored by New York University. This study seeks to provide extremely important and timely information about the best mechanism to ease re-entry and prevent relapse and re-incarceration for formerly incarcerated individuals. 

Individuals with a history of opioid use disorder and an anticipated release date within six months are recruited while they are still incarcerated. Participants are randomized to receive either extended-release buprenorphine (XR-B) given subcutaneously or extended-release naltrexone (XR-NTX) by intramuscular injection. Both treatments are given monthly. Treatment begins prior to release and continues for 6 months afterwards.  
 
The study opened to enrollment at Rutgers in September, 2021. The Rutgers research team is well on their way to achieving their enrollment goal of 301 participants, with 85 enrollments to date. Congratulations and best wishes for continued success to Drs. Nyaku and Reeves and the Rutgers research team! 
Deep6 Screener Role Now Available
With the newest release of Deep6 (and provided the cost of the identifiable query has been built into the study budget), we can now create a role for study teams to directly access the database to see charts of potential subjects. This can be done once the CTO has built the query. We think this offers a real advantage to study teams because it will allow you to easily compare the inclusion and exclusion criteria to the evidence in Epic using a user friendly menu.

Once you have completed your review of the charts, you will have a list of patients you have determined appear eligible along with the name of their primary physician, allowing you to easily make contact to obtain referrals.

Training and access can be found here

Please email Justin Blucher j.blucher@rutgers.edu for more information.
Upcoming Events
RWJMS Clinical
Research Workgroup
Monday, November 21st, 2022
12:00 PM
Our monthly meeting for the RWJMS clinical research staff will be discussing EPIC, OnCore, Deep6, ClinCard, and more!
Collaboration and Inclusion of Patients in Clinical Trials – Understanding What’s Critical for All Stakeholders
Wednesday, October 26th, 2022
10:00 AM - 2:00 PM
Join us online to hear from patients, their families and advocates, scientists, physicians, and clinical trial specialists from hospitals and drug companies about the importance of a patient-centric clinical trial, better understanding the patient experience, and how we as an industry can improve.
Do you value science but sometimes have difficulty ….  

  • Explaining your research to someone you meet at a cocktail party or your next door neighbor?  
  • Talking to community groups about COVID?  
  • Talking with patients about your clinical research interests?  
  • Selling your commercialization idea to venture capitalists?  
  
If you said ‘yes’ to any of these questions, NJ ACTS can help!  
Creating Connections
Tuesday, October 25th, 2022

3:00 PM - 5:00 PM
This is a general session and all are welcome.  
The workshop is designed to help scientists and researchers learn to  
engage and inspire diverse audiences through effective communication  
 
Read more about the Alan Alda Center at https://aldacenter.org/

Applying to RWJBH for hospital resources


Does your research study have procedures, labs, or services that use RWJBH allocation of resources?


Ever wondered how your IRC/RUG application is processed?
RWJMS Corner
  • IRC/RUG applications can be submitted by submitting a form via this link.

  • RUG/IRC applications are reviewed by the IRC committee members on the third Wednesday of each month at 10:00 am.

  • Once your RUG/IRC study is approved, you will receive an email with the approval letter.

  • Please forward copy of RUG/IRC submitted form and Approval Letter to the CTO: clinicaltrials@rbhs.rutgers.edu
Will your study be conducted at or need University Hospital services?


The OCRA Receipt, issued by the NJMS Office of Clinical Research Administration (by way of the CTO), serves two important purposes and initiates two major study milestones:

  1. Submission of request for UH services
  2. Permission to begin initial IRB submission




For more information, visit the
OCRA website here.
NJMS Corner

There are three conditions that must be met before an OCRA Receipt can be submitted:

  • Study is submitted to OnCore
  • UH Scope of Services form is completed & provided to the CTO/OnCore (see here)
  • Coverage Analysis & Billing Plan Proposal completed by/with the CTO

After these conditions are met and the OCRA Receipt has been issued by the CTO, your study will be eligible to submit your initial IRB application(s).

NOTE: Rutgers IRB will require the Receipt to be uploaded to your IRB application.
OnCore Quick Tip:
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What do all those codes, modifiers, and abbreviations on my OnCore calendar mean?
Primary Designations
Tells you how the procedure/event will be paid for

PR = When a study procedure is going to be paid for by the study budget, it is marked with the "Pure Research" designation.

RC = When a study procedure is not going to be paid for by the study budget and has been deemed as billable to patient/insurance, it is marked with the "Routine Care" designation.

Common Supporting Designations
Tells you how or by whom the procedure/event will be performed

HSU = When a study procedure will be ordered in Epic or requires hospital involvement, it is marked with the "Hospital Service Utilization" designation.

OFF = When a study procedure will be sent or performed at a central study lab or a non-Rutgers entity, (i.e., Covance or Univ. Radiology Group), it is marked with the "OFF" designation.

CRSE = When a study procedure is performed by research staff and has no risk of being billed to the patient/insurance (such as I/E assessment or questionnaires), it is marked with the "Clinical Research Staff Effort" designation.

DATA = When a procedure has been performed for routine, clinical reasons unrelated to the study, but the protocol asks for the resulting data to be collected, it is marked with the "DATA" designation.

Additional Codes & Modifiers Required by CMS for
Clinical Research Claims

Disclaimer: Don't worry, in most cases, you won't need to commit
this information to memory, but it is important to understand
the rationale and concept behind these clinical research regulations!

For Medicare qualified clinical studies that have study procedures marked as RC, CMS requires one of the following codes be listed to identify if CMS is paying for (1) a routine procedure (common) or (2) an investigational procedure (rare).

Q0 = Investigational clinical service provided by CMS in a clinical research study that is an approved clinical research study.
Q1 = Routine clinical service provided by CMS in a clinical research study that is in an approved clinical research study

Why are you telling me this?

Fortunately, OnCore sends the Designations and Modifiers for each study to Epic and the hospital billers automatically, but, first, the research nurse or coordinator needs to confirm this for each patient/procedure via Epic's Research Charge Review module.

Then, when hospital billers receive your confirmation, they'll do one of the following:

  • If PR: remove the charge from the patient chart and invoice the study team/department
  • If RC1 (RC+Q1): file claim to bill Medicare as a routine procedure that is study-related
  • If RC0 (RC+Q0): file claim to bill Medicare as an investigational procedure, but ONLY as permitted by CMS regulation

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Clinical Research Pet of the Month
If you want your favorite pet featured in the next newsletter, reach out to us via clinicaltrials@rbhs.rutgers.edu
October’s RBHS Clinical Research Pets of the Month are ZuZu, VinchenZo, and Mazy. Their parent is Scot Stenroos, a clinical research coordinator from RWJMS Neurology.

ZuZu is a COVID rescue. She is mostly Boxer (means she loves everyone and says so all the time, sometimes loudly) and bulldog (stubborn, stubborn, stubborn). ZuZu’s biggest superpower is snuggling, followed by chewing up all the sticks in the yard and keeping the deer away from the flowers. Her favorite thing, not counting food, is belly rubs.

Her best non-human friend is VinchenZo (black and white) who follows ZuZu around like a puppy. VinchenZo's superpower is the ability to fall off of/run into pretty much anything. Currently exploring gravity by knocking anything and everything off of tables, counters etc.

MaZy (M on forehead) rounds out the group with the superpower of instant on and full volume purr. Favorite thing is to taunt ZuZu.