To better understand the potential benefits and side effects of medicinal cannabis on physical and mental health, Dr. Tammy Chung (RWJMS-Psychiatry) and her research team began recruitment for the Cannabis Health Project (CHP), funded by the National Institute on Drug Abuse (R01 DA058663) in January 2025. The CHP is a naturalistic, longitudinal observational study on the physical and mental health effects of medicinal cannabis use. The CHP will enroll 400 adult participants who have a New Jersey medical cannabis patient ID card, and who primarily report smoking or vaping cannabis for conditions that include anxiety and chronic pain, which are the most common reasons for using medicinal cannabis. Participants will be followed at 6-month intervals using online surveys over 2-years. In-person visits also occur at baseline, 1- and 2-years to collect a urine sample (to assay THC and CBD metabolites) and to examine lung functioning (spirometry). Assessments are followed by 14-days of daily phone surveys to obtain fine-grained information on, for example, cannabis use, symptom relief, and any side effects. Study results will provide information to help inform clinical practice guidelines regarding the use of cannabis for therapeutic reasons.

To learn more about the CHP, click here

Congratulations, Dr. Chung and the CHP team!

From Left to Right: Onumaraekwu Opara, Tammy Chung, Ayse Sert Oti, Mary Bridgeman, Marc Steinberg

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!

ICH GCP E6 (R3) is here!

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use issued its final version of the revised Guideline for Good Clinical Practice (GCP) in early January. This major update takes into account the changes and innovations in our field over the past number of years, particularly related to the COVID-19 pandemic. There are many important revisions that will impact how we run our clinical trials, so all study teams are urged to familiarize themselves with the revised guideline. 

There are many important revisions that will impact how we run our clinical trials, so all study teams are urged to familiarize themselves with the revised guideline. Click here for a copy of the final ICH-GCP E6 (R3) guideline. There are also a number of educational resources to explain the changes, including a webinar recording through WCG as well as the ACRP Guidelines and Regulations Resource Center.

Reminder: If your study has billing risk (i.e. the schedule of events entails billable clinical procedures such as labwork, x-rays, ECG, etc.), it is absolutely critical that the CTO has opened your study to accrual in OnCore BEFORE participants are enrolled. This will assure that the research charge processes are put in place, which will prevent your participants from receiving bills for research procedures that are meant to be billed to the study.

Please be sure to check the study status in OnCore before enrolling your first participant. If the status is “CTO Signoff,” this means that the CTO has completed all start-up activities and the study is ready to be opened. If you have gotten the sponsor’s OK to start enrolling, simply click PC Console -> Status -> Open and enter the date you were activated. 

If the study status is either “SRB approval” or “IRB approval” and you are ready to begin, please email the CTO right away so that we expedite the processes on our end to assure that everything has been set up appropriately to manage the billing risk.

Please shoot us an e-mail to clinicaltrials@rbhs.rutgers.edu with any questions about this process.

RUBIES stands for the Rutgers University Biostatistics & Epidemiology Services center, which is under the umbrella of Rutgers Health and is housed within the Rutgers School of Public Health.

They are the “action arm” of the Biostatistics, Epidemiology, Research Design (BERD) core within NJACTS primarily responsible for facilitating the translation of science into practice by providing easily accessible advanced clinical study design and data analysis support on a fee-for-service basis. Their team of biostatisticians and epidemiologists cover a wide range of expertise and are committed to offering the highest quality of service to investigators.

If you’re at the early stages of your study design, have already collected data and are unsure how to analyze it, or need help drafting up your manuscript, the RUBIES team is here to help at any point. Click here for a guide that includes recommendations for how to engage with RUBIES to ensure the collaboration is productive and successful!

Questions? Contact the RUBIES Project Manager, Natale Mazzaferro, at natale.mazzaferro@rutgers.edu. Ask them about their Canvas page where they house biostatistics and epidemiology workshops!

Coming in June 2025:

Members of the NJ ACTS GREAT (Genetically Informed Research, Education, and Treatment) core will present on Genetic Testing in Clinical Research. Stay tuned for more information!

Jonathan Casey MD, MSc

Vanderbilt University Medical Center

This lecture will:



1. Discuss the rationale for platform, adaptive, and decentralized trials.

2. Review the capability and limitations of the REDCap Randomizatoin 1.0 to support such trials

3. Describe the design and development of the REDCap Randomizatoin 2.0 Toolkit

4. Discuss potential tradeoffs between statistical efficiency and operational efficiency in randomized trials.

The CTO recently launched a new portal to streamline common requests. This portal replaces our old DocuSign request process, and serves as a “one-stop shop” to request access to the various electronic systems we manage (i.e. OnCore, eReg, Advarra University, ClinCard, Deep6, DocuSign, etc.) and to request various services related to these systems (for example, OnCore reports, CAM requests and more.)  We hope this process will be less burdensome for our users and that it will allow us to more efficiently address your needs. Please check it out by clicking here and letting us know what you think!

EPIC Resolute Implementation & Research Functionality at University Hospital

On November 10th, we officially launched the implementation of EPIC Resolute and the research functionality at University Hospital. The Office of Clinical Research Services would like to extend its heartfelt thanks to all Rutgers Research staff for their dedicated work in making this "Go Live" a success. While we’ve encountered a few challenges along the way, rest assured that we’ve been actively communicating your concerns and compiling a list of items to refine in collaboration with UH-IST and EPIC.

Upcoming Training:

We are excited to announce an upcoming Cadence class for Research Registration and a Slicer/Dicer class focused on research. Stay tuned for more details on these sessions!

Additionally, this winter, we will be hosting an "open discussion session" for NJMS research staff. Join us as we discuss the shared Research Enterprise with our office and Executive Leader, Franklin Hickey. More information will follow soon.

Billing and Documentation Reminders:

If you come across a study that requires a billing grouper to reduce or eliminate billing review, please contact Arleen Wallen at wallenar@uhnj.org or at 973-972-7809.



A couple of important reminders for all research staff:

• Please refer to the Billing Grid in Oncore for your studies to identify what is categorized as RC (Research Charges) or PR (Professional Charges) in your billing reviews.
• Ensure there is a Research Note for all visits so we can accurately compare the visit column during billing reviews. This helps minimize the need for charge returns.
• A Research Note should also be written to document the Informed Consent process.



You can edit the Research Note Template or create your own templates to better suit your needs.

Once again, thank you for all your hard work and dedication as we continue to refine this process together.

Arleen Wallen & Eduardo Torres

University Hospital, Office of Clinical Research Services

The Imaging Center at 10 Plum Street (formerly University Radiology Group) is now managed by RWJUH. Requests to use this center for research imaging are now handled through RWJUH, by completing the RUG/IRC form, available through this link: RUG/IRC Committee Form | RWJ University Hospital  

February's clinical research pet of the month is Beaufort! His pet parent is Rebecca Freiday, grants and contracts manager from NJACTS.

Rebecca was casually scrolling through Facebook when she saw a post from a group called SOS (Save Our Snoopies) Beagle Rescue and saw a very handsome dog needing rescuing. Something in her heart pulled her towards this pup, and she was compelled to ask her husband, Leo, what he thought. “Aw, he’s cute! Beaufort, what a great name. If you want to, put in an application to adopt him.” “I’ll think about it,” Rebecca said.

Rebecca, not being prone to rash decisions, mulled it over for a couple of days and decided to put in an application after all (the application required answering fifty or so questions, two references, and a fairy dog-mother just in case). That night when Leo came home, Rebecca said, “I put in for the beagle adoption today.” Hilarity ensued when Leo, who had forgotten about the beagle, said, “You put in for a legal adoption?!”

Fast forward and the application was approved! Piper, Leo, and Rebecca all trucked over to Pennsylvania where Beaufort (pronounced Bow-fort) was being fostered at a doggie daycare center. Beaufort was originally from Kentucky, but his former owner surrendered him and his brother to a rescue, citing that they had too many dogs. From Kentucky, Beaufort went to Tennessee for veterinary care and then came to PA.

As soon as they trotted him out from the back, Leo and Rebecca gasped simultaneously- he was just too cute! “As long as Piper gets along with him, it’s a done deal,” Rebecca said. Beau was a bit skinny, entirely food driven, and half-feral with no obedience training in evidence whatsoever, but when he noticed Rebecca and Leo crouched down, he flew into their arms for cuddles (at least until he noticed a bag of training treats up on the counter). He came home as part of the family that afternoon.

It’s been almost two months, and Beaufort, aka Beau has acclimated well to his new home and his two big sisters, Piper and Blue. He is a good-natured, sweet, and playful fellow. He is a poor judge of character and would be friends with the devil for a snack. His favorite activities include counter-surfing, looking for weaknesses in the fenced-in backyard (hence the Badger in Badgerpig); wrestling, playing chase and tug-of-war with Piper; using his big beagle baying voice, tracking squirrels and rabbits; smelling all of the things; eating; and cuddling (which he’s still trying to figure out, he tends to stand awkwardly with his feet on your chest until he curls up next to you). He’s been on several adventures and can tell you he is not a fan of the cold; he’ll stop walking and whimper pathetically until you pick him up and stuff him in your coat to warm up and has been carried home on a few occasions. He’ll fall asleep in your arms and just wants to be with people. Beau is an agent of joy and chaos and is forever welcome in his new family.

Congratulations to Beaufort and Rebecca!

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.