This month we are shining the spotlight on the RWJMS Clinical Research Center's (CRC) role in the Cystic Fibrosis Foundation’s Therapeutic Development Network (TDN) through the conduct of TDN-sanctioned clinical trials. Their participation reflects the commitment to advancing research that addresses the evolving needs of individuals with cystic fibrosis.

The CRC has supported multiple TDN studies for over 10 years as a TDN site, including the groundbreaking Vertex-sponsored trials which evaluated Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulator therapies that have transformed the lives of patients living with Cystic Fibrosis. Currently, ongoing studies include STOP-360 and STRONG-CF.

Rutgers was recently recognized in the STRONG-CF newsletter for enrolling into a cohort with particularly strict eligibility criteria—highlighting the CRC's attention to detail and dedication to protocol-driven research.

The collaboration with the TDN continues to underscore the importance of high-quality clinical research in bringing new therapies to the CF community.

Congratulations Dr. Jagpal, Dr. Hussain, and the RWJMS CRC team for this important work!

From left to right: Sheila Redding (Research Coordinator), Eileen Jansson (CF Center RN), Sabiha Hussain, MD (Sub-Investigator), Fei Chen (Research Manager), Sarah McCracken (Research Coordinator), Sandra Johnson (CF Center Clinical Coordinator), Erin McElroy Barker (CF Center Coordinator/Social Worker), Darshana Patel (CF Center Respiratory Therapist). Not shown: Sugeet Jagpal, MD (Principal Investigator).

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!

The Trial Innovation Network (TIN) Informed Consent Guidance Manual

The Trial Innovation Network recently released a new guidance document, entitled “Informed Consent Guidance Manual: Best Practices for Ensuring Comprehension and Obtaining Consent,” available for download on the TIN website. This manual will be very beneficial to new and experienced coordinators alike, and has excellent tips for navigating complex consent scenarios, such as determining decisional capacity, language barriers, assent for pediatric participants and administering remote consent.

Maeve Tischbein, PhD

Mariela Rodriquez, MPH

Delicia Burts, MPH

A promising strategy to overcome challenges associated with the recruitment, retention, and engagement of study participants is to involve prospective participants in the design of clinical trials. The ResearchMatch Expert Advice Tool is an information gathering process facilitated by the ResearchMatch. Through this process, opinions related to study design are obtained from potential study participants and shared with researchers in the form of a report containing actionable recommendations. This tool was built by the Recruitment Innovation Center and is available to study teams through the TIN. This presentation will describe the tool and provide an overview of previous use cases to highlight how the Expert Advice Tool might benefit your study.

Greenphire is introducing a new product enhancement for the Visa program which will allow participants to choose direct deposit to their bank account as an option for receiving study payments or reimbursements. Stay tuned for more information in the upcoming months. Feel free to reach out to us at clincard@rbhs.rutgers.edu for more information.

Gary Heiman and Jessica Salvatore of the NJ ACTS GREAT (Genetically Informed Research, Education, and Treatment) core presented on genetic testing in clinical research on June 2nd.

You can watch their talk, Recruiting subjects for genetic studies: What study teams need to know using the link below:

Passcode: @rcST2Lw

Is your clinic moving? Just a reminder that this may entail a bit of paperwork. Let your study monitor know as soon as possible if you have one, but you will likely need to update the IRB application, the FDA Form 1572 or similar regulatory documents, shipping addresses for study supplies, and possibly the consent form. If you are moving to a clinic that is hospital-based practice, there will likely be a process to obtain approval from the hospital as well.

The new location to log into eReg is Advarra One. This is the same location to log into OnCore.

The RWJBH Care Link team took over responsibility for remote monitoring requests as of 4/1/25 and has provided new tip sheets to outline the process for study teams to make a request as well as one to provide to study monitors. Monitors must provide a Certificate of Insurance (COI) in order to access Care Link. If you or your monitor have questions specifically about obtaining a COI for this purpose, feel free to reach out to the CTO at clinicaltrials@rbhs.rutgers.edu for assistance.

Clinical Research Pet of the Month

June's clinical research pet of the month is Bella. Her pet parent is Fei Chen, Nurse Manager from the Clinical Research Center.

Meet Bella, the Chen family cat and reigning queen of the house! Bella was adopted when she was just 3 months old from the Somerset Animal Shelter. She’s now 9 years old, but still has the same playful spark she had as a kitten. She was named after Bella the vampire from the Twilight movies—partly because she’s mysterious and elegant, but mostly because she has very sharp little teeth!

Bella’s favorite game is fetch. Yes, fetch! Toss her a ball, and most of the time she’ll bring it back like a tiny furry retriever. When she’s not playing, Bella loves watching “Cat TV” on YouTube. She’s especially fascinated by bird videos and will always go behind the TV screen to try to “catch” them. She also spends her mornings on the cat tree by the window, making her funny chattering sounds at real birds, convinced she can reach them through the glass.

She’s a loving and affectionate companion who follows Fei everywhere around the house. When she’s ready to snuggle, she’ll curl up next to her and start “making biscuits” with her paws—her way of showing love (and claiming Fei as her human).

Bella may be small, but she’s got a big heart, a big personality, and yes, very sharp tooth!

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.