May 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
The World Trade Center Health Program
The World Trade Center (WTC) Health Program is not a traditional research study but rather a federal health care program for those directly affected by the September 11th attacks. The Rutgers WTC Clinical Center of Excellence at EOHSI, led by Dr. Iris Udasin, provides care, including annual monitoring exams, to over 5,000 first responders (rescue, recovery and clean-up workers) who were exposed to WTC toxins. While the primary purpose of the WTC is health care, the program strongly supports research by encouraging patients to share their data with the WTC data center. At their initial monitoring visit, all patients are given the option in the consent process to allow their data to be entered into the WTC database at the Icahn School of Medicine at Mount Sinai (ISMMS). The collected longitudinal data include demographics, WTC exposure, medical history, pulmonary function assessments, and health conditions from over 65,000 enrolled patients, some of whom have been followed for 20 years. Data from both individual clinical centers and the entire cohort are made available to researchers.

Additionally, the WTCHP has regular funding opportunities to support both observational and interventional research studies. At Rutgers, Dr. Udasin has had a long collaboration with Rutgers investigators recruiting WTC responders for studies on many health conditions including sarcoidosis, chronic rhinosinusitis, and GERD. After observing an increase in head and neck cancer patients in the EOHSI clinic, Dr. Udasin contacted Dr. Judith Graber (Rutgers SPH) who conducted a case-control study in the first responder cohort to identify risk factors in this population. Interest in increased cancer rates in WTC firefighters also led Dr. Graber to develop a larger study (Firefighter Cancer Assessment and Prevention Study) in volunteer firefighters. Perhaps Dr. Udasin’s longest collaboration has been with Dr. Jag Sunderram (RWJMS) who has been investigating the health effects of obstructive sleep apnea in WTC responders through a series of NIOSH-funded studies. Dr. Udasin and Sunderram are currently collaborating with Dr. Indu Ayappa (ISMMS) on a longitudinal, observational cohort to determine the relationship between untreated OSA and the development of Alzheimer’s disease (WTC AD). Responders are recruited by the EOHSI research coordinators, Alicia Legard and Adriana De Resende, at the EOHSI clinic. Participants undergo cognitive testing at EOHSI and are then scheduled for polysomnography (ISSMS) and a PET-MRI (New York University). The testing is repeated two years later to assess any cognitive decline and associated markers.

The WTC cohort at EOHSI is very supportive of the research programs, not just to find answers to their own health problems, but also to give back to Dr. Udasin and the entire WTC health program staff of nurses, mental health specialists, and administrative staff who have provided excellent health care for 20 years!

Congratulations to the EOHSI team for this important work! 
EOHSI WTC Research Team Members (l-r): Ceretha Hall-Dyke, RSN, RN; Linda Christiansen, RN; Alicia Legard; Kathy Black, PhD; Adriana De Resende; Iris Udasin, MD and Medical Director.
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
NJ ACTS REGULATORY SUPPORT TEAM
 
Are you feeling frustrated? Do you have questions about your research project or IRB submission?
 
The NJ ACTS Regulatory Support Team is here to help!

Request a regulatory consult here
 
We can help with questions about:

  • Human subjects research
  • IRB submission
  • Regulatory requirements
  • Special/Vulnerable populations (children, prisoners, pregnant women, etc.)
  • Other regulatory issues
(Image courtesy of Weill Cornell Medicine)
You can also reach the Regulatory Support Team at 848-801-9355 or by e-mail to njactsregulatory@rbhs.rutgers.edu

Farah Anwar
Regulatory Affairs Manager, Clinical Trials Office

Anthony Gonzalez, MS
Manager, Quality Assurance & Quality Control - NJ ACTS
Rutgers Authorized Signatory reminder
(Image courtesy of Access Tufts)
This is just a friendly reminder that, as per Rutgers Policy 50.3.13,  Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs) and any amendments to those agreements must be signed only by the authorized signatory for research contracts. 

Melissa Matsil, Executive Director, Rutgers Research Contract Services (or her designee), is the authorized Rutgers signatory for these agreements, meaning that investigators and department heads do not have this authority.
 
The process to request execution of a CDA is to initiate the Document Review request through RAPSS. The process to initiate review of a new (Non-Oncology) clinical trial agreement and of amendments to a CTA is through OnCore. Please e-mail the CTO at clinicaltrials@rbhs.rutgers.edu if you have questions about using either of these two systems.
 
Please let us know of any instances in which an investigator has signed an agreement without the agreement having gone through the established channels. We will notify the Contract Research Organization or sponsor and begin the review process.  
Upcoming Events
RWJMS Clinical
Research Workgroup
July 17th, 2023
12:00 pm
Agenda TBA
Open Demo
 
June 1, 2023
1:00 pm

The Advarra team will walk through OnCore’s most impactful capabilities, demonstrating key workflows our customers find most valuable.
RWJMS Corner
The Serious Adverse Event (SAE) integration is now available in OnCore. When documenting Adverse Events in Epic, those flagged as serious can now be pulled into OnCore. This may be useful to study teams for both IRB and payment tracking purposes. To import SAEs in OnCore, go to the subject’s record in the study, select the SAE button as normal, and then click “Import SAEs” instead of clicking New. This will pull the SAE from Epic into OnCore. You can still have the ability to update the SAE by opening the SAE to document additional fields. Additional information will be provided at our next monthly meeting. For questions or training on this topic, reach out to Jonathan Carter, jonathan.carter@rutgers.edu
NJMS Corner
How to Access the Research Note Template in Epic

 Scheduled visit
2.     Click on the Research Note Section in the Visit Navigator
3.     Click Create Note
4.     The Note activity will open on the Right panel
5.     In the Insert SmartText field, type Research and hit the Enter button on keyboard
6.     Select the appropriate note (Research note or Research Follow up note)
7.     Complete documentation. You can address the yellow highligted smartlist by clicking the F2 key on your key board. Once you hit the F2 key, the selections will open
8.     Sign the Note
9.     Click Accept to file the note
Access Inpatient Notes
1.     Click on the Patient list from the start up activity tool bar
2.     Click on System list Folder
3.     Open Unit Folder
4.     Select the Unit and Open the patient chart
5.     Click on the Notes Activity and Click on New Note
6.     The Note activity will open on the Right pane
7.     In the Insert SmartText field, type Research and hit the Enter button on keyboard
8.     Select the appropriate note (Research note or Research Follow up note)
9.     Complete documentation. You can address the yellow highlighted smartlist by clicking the F2 key on your key board. Once you hit the F2 key, the selections will open
10. Sign the Note
OnCore Quick Tip:
Orphaned Visits
Verified Visits and New Calendar Versions

In a new calendar version, visit procedures may be added or removed. If a visit has been verified prior to switching the calendar version, the new subject calendar display reflects this change.
In the scheduling grid, the subject calendar displays an 'X' for the procedure with a subscript 'A' or 'D'. The 'A' subscript indicates that a procedure that was not performed as part of the original visit schedule has been added to the calendar, the 'D' subscript indicates that a procedure that was performed as part of the original visit schedule has been deleted from the calendar.
If a visit was entirely removed from the schedule in a new version of the calendar and that visit has already been verified, the visit will show on the Orphaned Visits tab on the Subject Calendar.

Subject Console -> Calendar -> Orphaned Visits:
Clinical Research Pet of the Month
May's pet of the month is Naru! Naru's human is Katie Nan, Clinical Research Coordinator from the NJMA Hepatology Research Team.

Naru is a shy orange tabby who takes his time getting used to meeting new people. Luckily, he can be easily bribed with treats! He can be found napping in the sunlight or chasing the mysterious red dot that emerges from a laser machine. He also enjoys the usual sport of bird-watching, specifically the nest of mourning doves that is perched above the bedroom window. At 10 years old, he is still mischievous at times and is living his best life!

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