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March 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
OARS

Opioid Analgesic Reduction Study
Our spotlight this month is on the RSDM’s Opiod Analgesic Reduction Study (OARS). Dr. Cecile Feldman-Zohn, RSDM Dean, is the PI on the overall NIH grant as well as for the study here at Rutgers. The OARS study seeks to answer a critical and timely question, as Opioid related deaths are rising alarmingly in the United States with dentists among the leading prescribers of opioid analgesics. OARS is an $11.5 million NIH-National Institute for Dental and Craniofacial Research supported multi-site double-blind, randomized, clinical trial aims to demonstrate the non-inferiority of a combination of over-the-counter analgesics (ibuprofen and acetaminophen) as compared to the most prescribed opioid analgesic (hydrocodone and acetaminophen) by dentists for the management of acute post-operative surgical pain.

Patients undergoing impacted mandibular 3rd molar extraction are randomly assigned to either the OPIOID group (patients assigned to receive hydrocodone 5mg/acetaminophen 300 mg) or the NON-OPIOID group (ibuprofen 400mg/acetaminophen 500) to manage their postoperative pain.  To date, 1660 subjects have been enrolled at five-clinical sites, including University of Illinois at Chicago, University of Maryland at Baltimore, University of Michigan, University of Rochester and Rutgers University. Ultimately 1800 participants will be enrolled and be followed for one week post-surgery. Information is collected throughout the post-operative period on the patient’s pain experience, pain interference, sleep quality, adverse events, need for rescue, left over opioid tablets and fulfillment of an additional post-operative opioid containing analgesic within 6 months of surgery.  

Congratulations to Dean Feldman and the RSDM study team!
From left to right:

Cecile Feldman, DMD, MBA – Principal Investigator
Janine Fredericks Younger, DMD - Clinical Chief
Julie Chapman-Greene, PhD, - Project Manager
Jeremiah Colon, CPhT – Pharmacy Technician
Yosmery Garcia, RDH, BS- Research Coordinator
Megen Colon, CPhT – Pharmacy technician
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
Consenting to ClinCard
The standalone Rutgers ClinCard consent form should no longer be used for new studies moving forward. Instead, Rutgers HRPP has provided new template language to insert into the payments section of the main study consent form, for studies using ClinCard.  You’ll note that the language differs, depending upon the amount of money the participant could possibly earn in a tax year, and whether or not ClinCard is being used to reimburse travel expenses. 

The new template language can be found on the HRPP website. (See the Human Research Protection Program Toolkit, section B - Consent Templates, under Consent Addenda.) This language should be used regardless of whether Rutgers is the IRB of record or if a commercial or central IRB is used. Please note that the tax withholding functionality referenced in the template has not been officially launched yet, however, this is expected in the near future. If you have questions, please e-mail us at clincard@rbhs.rutgers.edu
Upcoming Events
RBHS Clinical
Research Workgroup
May 15th, 2023
12:00 pm
Barbara DeMarco, PhD, Senior Associate Dean for Education, and Director, Rutgers Biopharma Educational Initiative will be our guest speaker. The topic will be the new CRC badging program!
Open Demo: Advarra eRegulatory Management System

April 4, 2023
1:00 pm

Join us for an open demo of Advarra eReg, where you will tour current and upcoming workflows driven by our site community to improve regulatory processes and compliance.
RWJMS Corner
EPIC Report Request
Look for more details in the future about using Epic tools for research, but, for now, if you need to request a report of Epic data for research, you can do so via this link: 

You will select “Epic Report Request” and specify that it is for research.
NJMS Corner
NJMS Clinical
Research Workgroup
April 10th, 2023
12:00 pm
UH-Newark updates and more!
OnCore Quick Tip:
What is summary accrual in OnCore?
Summary accrual is used for clinical trials that do not require a calendar or detailed subject visit tracking. You can find the summary accrual information for a protocol in PC Console and then clicking the Accrual tab on the left sidebar.
The Accrual Summary table displays subject accruals by date range, institution and institution type.

From Date
The start date of this summary accrual entry.

Thru Date
The end date of summary accrual entry.

RC Accrual
The number of accruals at the Research/Cancer Center during the date range.

VA Accrual
The number of accruals at the VA during the date range.

Affiliate Accrual
The number of accruals at all affiliates during the date range.
The Accruals table displays subject summary accrual entries.
Creating a New Summary Accrual Entry
Clicking the Update button will display an add block to add summary accrual entries.
The fields in the add block are those defined in the previous section. You may capture general subject information as well as recruiter information. There are some rules and conventions enforced by this add block:
  • Required fields are marked with an asterisk.
  • From Date and Thru Date must be in the same calendar year.
  • The Institution drop-down displays participating institutions. When an Institution is selected, the Internal Accrual Reporting Group is automatically populated.
  • When a non-oncology library is selected, the Diagnosis field appears instead.
Clinical Research Pet of the Month
March’s Clinical Research Pets of the month are a long and distinguished line of Newfoundlands. Their humans are Dr. Cecile Feldman-Zohn, Dean of the Rutgers School of Dental Medicine and her husband, Dr. Harry Zohn, Professor of Periodontics.

We asked Dr. Feldman to tell us about the breed and the unusual naming convention for the dogs, and this is what she told us:

“Of course there are stories to tell.

It is believed that Newfoundlands originated from the maritime providences in Canada. The Labradors and Newfoundlands are closely related with the Labradors once known as the Lesser Newfoundland and the Newfoundlands known as the Greater Newfoundland. Newfoundlands were bred to be working dogs. They are extremely strong swimmers (can tow boats with people in them) and pull 1,000 pound carts. They served on merchant marine ships and fishing boats. When sailors fell overboard, they were sent out to rescue or retrieve them. They were also employed to pull in fishing nets.

There were some famous Newfoundlands including a Newfoundland who went with Lewis and Clark on their expedition west and another which lived in the White House during the Kennedy administration.

Our first five Newfoundlands were chocolate colored – thus the chocolate theme. (R-Bee is the exception because she was adopted at 6 years so she came with her name.) Brown Newfoundlands are not very common. They was also a lot of discrimination against them because of their color so it is rare to see a Newfoundland win a show dog title. Our current two, Newton and Einstein are black (the most common color) and thus we changed our theme to scientists who have foods named after them. We raised Herhsie, Keebler, Nestle and Newton from young puppies and adopted R-Bee, Bosco and Einstein when they were older. Both Bosco and Einstein were young enough to have their names changed.
We don’t show our dogs, but we do train them to be companion or therapy dogs and have experimented with working toward working dog titles. Newfoundlands can earn titles for water rescue or draft work. We have only achieved a “tadpole” title which is an unofficial title which is equivalent to graduating from Kindergarten.  

Dr. Zohn does help administer the water rescue dog title tests. It is equivalent to the dental licensing exam (which he also helps administer.). If an owner wants to get their dog certified as a water rescue dog, they have to complete a number of competency exams which take place on a lake. Dr. Zohn may drown 25 times in a weekend and might be rescued successfully just a handful of times. It isn’t easy to complete the life-saving tasks. He also has helped in winter draft tests which can be a whole lot of fun when there is lots of snow.

Newfoundlands are known as gentle giants. They range in size from about 120 pounds to 200 pounds. Ours have all been females and have weighed in at 140 pounds to 180 pounds. They are fantastic family dogs (Nanny from Peter Pan was a Newfoundland) and love the cold (ours sleep outside when it gets below 20 degrees). They can get into a lot of mischief. For example, Nestle stole our 20 pound Thanksgiving dinner one year as it was sitting on the counter cooling. We ended up serving hot dogs that year. And just this year, Newton who has an insatiable appetite for electronics stole one of my iPhones and buried it under two inches of mud. I was only able to find it by hearing the find-my-phone pinging coming from my daffodil flower bed.” 

Congratulations, Drs. Feldman and Zohn and thanks for giving us a glimpse into the world of Newfoundlands!  
If you want your favorite pet featured in the next newsletter, reach out to us via clinicaltrials@rbhs.rutgers.edu