Our previously published newsletters are available on our website. You can find them here.
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Research Spotlight:
CLOCK study
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- Rutgers Robert Wood Johnson Medical School (RWJMS) has been awarded a $30 million+ grant from the NIH to help lead a study on the long term and delayed impacts of COVID-19 in children and young adults. The RWJMS lead is Dr. Lawrence Kleinman.
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The local component of the study is known as CLOCK, the Collaborative Longterm study of Outcomes of COVID-19 in Kids.
- Local recruitment will be conducted using the Rutgers RWJMS Pediatric Clinical Research Center at the Child Health Institute of NJ in New Brunswick. The primary clinical resources are the RWJMS Department of Pediatrics and the Bristol Myers Squibb Children's Hospital. Both are in New Brunswick. The Rutgers team will be recruiting in excess of 150 subjects.
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Eligible subjects include infants, children, adolescents and young adults, through 25 years of age. Infection with COVID is not necessary to participate, although about 8 in 10 of those accepted into the study will have had COVID, whether in the past or mor recently. A small fraction will be recruited within the month that they are infected. Long COVID or a history of other delayed impact from COVID-19 such as MIS-C is not required to participate in the study.
- RWJMS is also serving as a hub of a nation consortium or network, working with 11 other partners sites that will help the team to recruit more than 2,000 participants across the country.
- Partner organizations include the American Academy of Pediatrics and it Pediatric Research in Office Settings practice-based research network (PBRN), the American Association of Family Physicians and its PBRN, and academic medical centers in NJ, NY, CT, OH, MO, and CA. The two PBRN broaden the geographic scope to additional states and rural areas that might be distant from academic medical centers.
- The first phase of the study includes a home questionnaire, blood and saliva samples which are all provided from the comfort of their home. The second and third phase involve more in-depth bloodwork and testing such as lung function testing, brain imaging and cognitive testing
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For more information or to express interest in participating in the study, please email recover_clock@rwjms.rutgers.edu
- The study is part of the NIH-funded Researching COVID to Enhance Recovery (RECOVER) initiative
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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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RWJMS Clinical
Research Workgroup
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Monday, November 21st, 2022
12:00 PM
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Our monthly meeting for the RWJMS clinical research staff will be discussing EPIC, OnCore, Deep6, ClinCard, and more! |
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Announcing a new online training initiative for clinical research coordinators, available at no cost to new and current Rutgers employees! |
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Guidance on scanning signed consent forms into Epic coming soon. |
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Arleen Wallen has asked us to send along the following reminders to study teams:
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Research Note Templates: UH strongly encourages study teams to use the Research Note Templates which have been created in Epic in order to document the informed consent process and study visits. These templates are designed to facilitate documentation of the required elements. Please contact Arleen if you need additional information on these templates:
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2. Requirement to scan signed consent forms into Epic: If your UH approval notice has an ICF cover sheet and references a requirement to forward signed consent forms for scanning into Epic, please remember to do so. This requirement extends to ancillary and substudy consents, and re-consents as well.
3. Removal of the FYI Flag: When a patient goes off of a treatment study with multiple study visits, please remember to send an ICF coversheet to request removal of the FYI Flag in Epic so that treating clinicians know that the participant is no longer on the study.
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How do I upload new versions of blank consent forms to OnCore? |
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First, go to PC console in OnCore. Click on the reviews tab on the left sidebar and then click the IRB tab. Click add and you will enter the page with IRB information and the ability to add documents on the bottom half of the screen. Click add again and you will be able to add consent forms along with the IRB review information associated with that amendment. |
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The most important step is to click the RELEASE checkbox and then hit submit or submit and close. If you do not release the consent form, it will not be available in Subject Console in the below screenshot with available consents. |
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How do I document reconsent of a pediatric subject in OnCore when they turn 18?
RR Reconsent Requirement
If a reconsent requirement exists (see above details tab screenshot for the checkbox), the Consent Type displays as a link, followed by the letters RR. Clicking the link displays a popup window where you can indicate either that the new consent has been signed or that it is not applicable. Selecting one of these options causes the RR to no longer display next to the subject name in the CRA Console.
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Status
If the Consent at Age of Majority field on the PC Console > Main > Details page is set to Yes, the Status field displays the number of days until the subject reaches the Age of Majority.
Subject Age of Majority
This is automatically populated by the number configured as Age of Majority, but may be edited.
Reconsented at Legal Age
When checked, AM no longer displays next to the subject name, indicating that the reconsent requirement has been met.
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Do you ever wonder how you can rapidly on-board clinical research staff for a new clinical trial?
RBHS is partnering with Vitalief for a solution
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Clinical Research Pets of the Month |
November’s RBHS Clinical Research Pets of the Month are Chase and Wesson. Their owner is Jonathan Carter, Clinical Trials Office's Business Systems Analyst.
Chase is a 3-year-old Dutch Shepard and Belgian Malinois (originally from Belgium), who isn’t just a pet. Chase actively serves as a working dog for a local police department, where he specializes in identifying narcotics, search and rescue, and apprehension. If you’re familiar with the breed, you know that for Belgians, “calm” is unknown vocabulary. With energy as high as you can imagine, Chase is hyper alert and focused when he is on the job. But, after quitting time, he is equally energetic with his favorite ball, rope, or toy. Though intimidating in his professional role, he’s one of the sweetest and most affectionate dogs – as long as you’re an owner-approved guest.
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Running around the house with Chase is a rescue from Somerset county, Wesson! Wes (for short) is a 5-year-old Staffordshire Terrier, Boxer, Bulldog, Rottweiler…among other things. (Yes, he has been doggy DNA tested!) Unlike Chase, Wesson much enjoys a more typical canine lifestyle where his days are filled with laying on the couch and sleeping for at least 6 hours a day.
His favorite activity besides napping is enjoying the outside, whether that be to sunbathe in the backyard grass – or enjoying a stroll around the neighborhood. Very much like Chase, Wesson is extremely affectionate and enjoys the attention of being pet for hours and is sure to jump onto the couch to cuddle when watching tv.
Congratulations, Chase, Wesson & Jonathan!
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