Welcome Barnabas Colleagues |
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We would like to take this opportunity to welcome our RWJBH colleagues into the fold! As part of a larger effort to harmonize clinical research processes across Rutgers Health and our partner hospitals, Newark Beth Israel, Cooperman Barnabas Medical Center and Monmouth Medical Center are now live on OnCore for all of their clinical trials (not just cancer studies.) The Rutgers Health CTO will now be building RWJBH non-oncology clinical trials in OnCore and assuming other administrative tasks as well. We are very excited to begin this newest step toward a truly integrated academic health system and are very optimistic that this continued integration will result in many new and productive clinical research collaborations. |
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Research Spotlight: ACTIVATE |
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This month, we are highlighting ACTIVATE, a new study for Parkinson’s Disease being conducted at RWJMS under the direction of Dr. Gian Pal. Parkinson’s disease (PD) is a chronic, debilitating neurodegenerative disorder characterized by motor symptoms including slowness, rigidity, balance difficulties, and tremor with bothersome non-motor symptoms as well.
PD is believed to be caused by a combination of environmental factors (for example, pesticide exposure) as well as specific genetic risk factors. These genetic risk factors range from very rare variants that lead to “familial Parkinsonism” to more common variants that increase one’s risk of developing PD, including mutations in the glucocerebrosidase (GBA1) gene.
ACTIVATE is a randomized double-blind placebo controlled clinical trial aimed at testing the safety, tolerability, and efficacy of BIA 28-6156, an allosteric activator of GCase, in GBA1-PD patients. This is an exciting trial since the intervention is aimed at a specific subset of PD patients (those with GBA1 pathogenic variants) rather than targeting all PD patients. By focusing on this subgroup of PD patients with common biologic underpinnings of their disease, this type of trial may have a greater likelihood of success compared to a trial for the PD population as a whole.
Congratulations to the RWJMS-Neurology study team (from left to right): Dr. Gian Pal, Dr. Marco Russo, Edward (Scot) Stenroos, Arcival Salazar and Ahmad Almelegy
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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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Want to beta test the eIRB+ system? |
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Join our cutting-edge eIRB+ project and revolutionize the way we handle Institutional Review Board (IRB) protocols! As a beta tester, you'll play a pivotal role in shaping the future of streamlined and efficient research management. Contribute your insights as a research clinical coordinator to ensure a seamless user experience. Please email Swapnali.chaudhari@rutgers.edu with subject line "Beta Tester for eIRB+" with your interest.
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Important ClinCard Updates |
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Along with the transition from our current MasterCard program to a new Visa card program, a new pricing structure for current and new studies will go into effect starting 1/1/24. Once launched, the new visa program will entail an integration with Lyft for rideshares for our study participants, as well tax functionality, including the option of backup withholding for participants who do not provide a social security number. Be on the lookout for training sessions on the new system in early 2024. Please feel free to reach out with any questions in the meantime: ClinCard@rbhs.rutgers.edu
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New Research Staff Orientation |
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As a reminder, the CTO is now offering an orientation program for new research staff to help navigate the complexities of conducting clinical research at Rutgers.
To request an orientation session and onboarding package, clinical research staff can complete a brief survey to tell us about his/her expected responsibilities and about any prior work experience in clinical research. We will then work with the employee and their supervisor to supplement any planned orientation with a personalized session to review critical areas such as working with our partner hospitals, getting access to various software systems, etc. The scope of the CTO’s orientation is focused on policies, workflows, and available resources relevant to clinical research at Rutgers. Send us an email to clinicaltrials@rbhs.rutgers.edu if you have any questions.
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SMART IRB Agreement 3.0 Proposed Revisions |
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December 20th, 2023
12:00 pm
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The SMART IRB Agreement was launched in 2016 after extensive collaboration with government agencies, academic medical centers (including all Clinical and Translational Science hubs and many of their affiliates), and industry partners. To date, the SMART IRB Agreement has been signed by over 1130 entities, supported by (1) the SMART IRB platform, a robust online reliance system to support reliance requests; (2) numerous resources to train and educate the regulatory and investigator community, including a publicly-available learning center; and (3) a highly functional harmonization steering committee facilitating the alignment of policies and processes related to single IRB review.
This webinar will provide:
• A summary of the proposed changes
• How public comments are submitted
• An overview of the process, timeline, and requirements for signing and re-signing the SMART IRB Agreement version 3.0
• New and existing SMART IRB resources and educational tools
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Revamping OCRA Receipt Process for CTO studies |
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In pursuit of the CTO’s mission to streamline processes and increase efficiency, the CTO, UH-Newark, and Rutgers’ IRB have agreed to move forward with revamping the OCRA Receipt process, specifically for studies that fall under the purview of the CTO/meet OnCore criteria* The goal of this change is two-fold: (1) to eliminate redundant steps by incorporating the notification to UH and the IRB into existing workflows and (2) to allow the initiation of IRB applications and UH facility use agreements earlier in the study startup process, which will ultimately decrease study startup timelines.
At present, one of the main components of the OCRA Receipt is the Proposed Billing Plan, which takes time to develop and is contingent upon completion of a Medicare Coverage Analysis. Going forward, the CTO will instead utilize the Administrative SRB Approval notification (via OnCore) as the mechanism to (1) notify and provide basic study information to UH and (2) provide proof of UH awareness to the IRB (for Section 5.0 of eIRB). Additionally, the new Billing Plan Proposal that will follow the SRB Approval will also free up UH CRS (Arleen Wallen and Eduardo Torres) to prepare for UH leadership approval more efficiently.
*For clinical trials and prospective, observational studies. At this time, the OCRA Receipt process will remain unchanged for retrospective chart reviews and other non-CTO studies.
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Did you know that OnCore has shortcuts for dates? |
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Keyboard Shortcuts
t = Current day's date
n = Number of days
t+n = Current date plus n days
t-n = Current date minus n days
Examples: t+1 (tomorrow) or t-5 (5 days ago)
w+n = Current date plus n number of weeks
w-n = Current date minus n number of weeks
m+n = Current date plus n number of months
m-n = Current date minus n number of months
y+n = Current date plus n number of years
y-n = Current date minus n number of years
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Clinical Research Pet of the Month |
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December's clinical research pet of the month is Ranger, a 11-year-old Boxer who, despite his age, remains a puppy at heart. His pet parent is Emily Peters, research coordinator from School of Health Professions.
His enthusiasm shines through during walks where he gleefully fetches and collects sticks, only to leave them on the front porch. He enjoys soaking up the sun and spending weekends hiking in the Finger Lakes region.
While Ranger may lack the typical guard dog sternness, he is an instant friend for anyone who pets him. His unique greeting style involves a heartwarming cuddle and leaning against you making it impossible to resist petting him and leaving smiles in his wake.
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Congratulations Ranger and Emily! |
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