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August 2023 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.
Research Spotlight
Congratulations to Dr. Sugeet Jagpal and the RWJMS CRC for enrolling their first patient into the TIGRIS study! TIGRIS, sponsored by Spectral Diagnostics, looks at the efficacy and safety of the PMX cartridge for patients with endotoxemic septic shock. 

ICU providers have long been frustrated by a lack of good therapeutic options for septic shock, which generally requires ICU admission and has a high mortality rate. The majority of cases of severe septic shock are associated with endotoxemia (i.e. the release of endotoxin, a component of gram negative bacteria, into the blood stream.) The TIGRIS study approaches endotoxemic shock in two ways: 

1.      Use of the Endotoxin Activity Assay (EAA) – patients with sepsis and suspected endotoxemia are screened for endotoxin using this assay via a kit supplied by the sponsor.
2.      PMX Cartridge Hemoperfusion – patients with an endotoxin level between 0.6 to <0.9 units are eligible to be randomized to receive two extracorporeal hemoperfusion treatments using the PMX Cartridges plus standard of care vs. standard of care alone. The PMX Cartridges are treated with Polymyxin B, which adsorbs and removes endotoxin from the circulating blood. 

The PMX Cartridges are investigational in the US, however, have been available in Japan and the EU for more than 20 years.  

If you want to learn more about Endotoxemic shock and the TIGRIS study, you can tune in to an upcoming Lifetime show called The Balancing Act.
Debbie McCloskey (CRC Nurse Manager) and Fei Chen (Research Nurse)
Therese Pagulayan (CRC research assistant) and Gino Gan (MICU nurse at the hospital)
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!
Regulatory Tip of the Month
Important Update - Changes in WCG IRB Submission Process
As of 9/1/23, Rutgers Researchers will be able to submit WCG IRB applications directly to WCG. Click here for more information.
Reminder: Website Update
Just an FYI that our website URL has moved. Our old website will automatically redirect you to our new location.
Upcoming Events
RBHS Clinical
Research Workgroup
September 18th, 2023
12:00 pm
Join us for an update on recruitment strategies available to Rutgers researchers! The session will include live demos on Research Match, Epic's MyChart and Deep6 AI Cohort Builder.  
Single IRB Unlocked: IREx is the Key to Efficient Single IRB Review for Lead Study Teams
September 20th, 2023
12:00 pm
IREx – the IRB Reliance Exchange – is a freely available web-based tool to help lead study teams manage the single IRB requirements and streamline communications.

This presentation is aimed at lead study teams involved in multi-site research projects using an academic single IRB.
Congratulations to Debbie McCloskey on her retirement!
Please join us in bidding a fond Farewell to Debbie McCloskey. Debbie, who has been the Nurse Manager for the RWJMS Adult Clinical Research Center since 2007 will be retiring at the end of this month.

Debbie’s contributions to clinical research at RWJMS cannot be understated. As the nurse manager for the RWJMS Clinical Research Center, her mentorship of countless research nurses and study coordinators has been instrumental in the CRC’s success, as well as the success of research throughout RWJMS. In her 30+ years in clinical research at RWJMS, she has implemented hundreds of protocols, touched the lives of thousands of patients, and has contributed to the medical community in innumerable ways. Her early years as a critical care nurse provided her with a calm demeanor and a sense of compassion that has served to set the tone for the CRC. She is appreciated and beloved by her investigators, study monitors, colleagues and staff. She will be deeply missed.

While Debbie’s legacy is sure to live on at RBHS, we wish her the best as she starts this new chapter in her life.
RWJMS Corner
Epic Tip Sheet for CAM Requests
The Epic Research Team has provided us with a new tip sheet related to new requests for CAM accounts and Epic access. Please click here to download the tip sheet.
NJMS Corner
University Hospital Laboratory Documents
 
As a reminder, updated laboratory certificates and the Director’s Medical License are available from the CTO. If you need copies of these documents, just shoot us an e-mail to clinicaltrials@rbhs.rutgers.edu
OnCore Quick Tip:
Reminder: Change Reviews
Please make sure that you click "change review" for major protocol amendments (e.g., changes to study design or SOA), budget or contract amendments etc. to current studies in OnCore. The "continuation review" is not currently in use at our institution.

To submit a change review: Go to ePRMS Submission Console. Change review is located as the 3rd option under "Create Submission" as seen on the screenshot to the right. Please let the CTO know if you run into any issues. Thank you!
Clinical Research Pets of the Month
August's clinical research pets of the month are Olive and Alabaster. Justin Blucher of the Clinical Trials Office is the father of these two troublemakers!

Alabaster was the first addition of the family and was rescued from the Texas/Mexico border, hence his chihuahua origins. He is still slightly feral, but when he isn't shy and skiddish, he is a ball of energy. His potential Jack Russel origins explains his high energy play mode.

Olive is the newest addition of the family and was rescued from South Carolina. She is just like a sour patch candy, sweet or sour depending on the mood you catch her in. She balances out Alabaster with her lazy lifestyle, but she does enjoy the occasional tug of war. Her most famous feature is her punk rock hairstyle.

Congratulations Olive, Alabaster, and Justin!
If you want your favorite pet featured in the next newsletter, reach out to us via clinicaltrials@rbhs.rutgers.edu