Our previously published newsletters are available on our website. You can find them here.
|
|
Research Spotlight: BONEBRIDGE |
|
Dr. Jyung and his team at The Cochlear Implant Center at NJMS are gearing up to participate in an exciting new trial that will provide pivotal treatment to young children through 12 years old who have chronic hearing loss, often due to a congenital malformation of the ear canal (aural atresia). The study will explore safety and efficacy of the BONEBRIDGE implant system, an active transcutaneous bone conduction implant that offers an intact skin solution with lower complication rates and better hearing gains compared to other available treatments.
Making this implant available to young developing children will be key to preventing language and learning development delays. This trial will also allow The Cochlear Implant Center at NJMS to provide much needed hearing loss treatment to a community of pediatric patients and parents that is chronically underserved.
More info on their department and studies can be found here.
|
|
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 |
|
New 2023 Data Retention Requirement |
|
New European Union legislation that requires clinical trial master file data to be kept for 25 years from study completion requires actions from sites—including those based in the United States. Read the blog from ACRP here
Please be sure to check your clinical trial agreements, since it is likely that these new extended data retention requirements will be included. Study teams are strongly encouraged to archive study records after a study is closed, using the Rutgers Records Management services. If you have any questions about long term record storage, please e-mail us at clinicaltrials@rbhs.rutgers.edu.
|
|
Did you know that you can use eReg to upload and manage subject source documents? |
|
With the trend toward remote monitoring visits, and with the new requirement for extended essential document storage, we believe this is an excellent solution for study teams. See the section below for instructions as to how to upload source documents such as signed informed consents, diaries, laboratory results, etc., to participant-specific source documentation files within eReg. |
|
The Subject Audit report gives you a closer look at the subject information and subject documents that were added, edited, and deleted for a specified protocol. To review this information, choose the protocol and subjects from those you have access to. You can also specify a date range to limit the report output to that time period.
The report results include audit information including the action taken (create, update, or delete), what changed, the old and new values, reason for change, when the change was made, and by whom. Here's an example of what the report looks like:
|
|
For more information on eReg, visit our website.
|
|
RBHS Clinical
Research Workgroup
|
|
Announcing our first ALL-RBHS clinical research workgroup call! Please watch your inbox for a zoom invite to discuss topics including important updates in the Rutgers Human Subject Protection Program, new ClinCard tax functionality and consent language and much more. |
|
Are you or someone you know considering taking the ACRP certification exam during the Spring Certification Exam Cycle: January 15, 2023 – April 15, 2023?
The New York Metropolitan Chapter of ACRP is offering a virtual certification prep course/study group to assist you in your preparation via Zoom.
All are welcome to register for this preparation and review of covered topics on the ACRP certification exam. Register with Lisette Gonzalez:
call 917-881-4295
|
|
Clinical Research Coordinator Level-1 Badge |
|
Take advantage of the NJ ACTS Badge Program!
Whether you are a brand-new study coordinator or if you have been at this for decades, you may want to take advantage of the new NJ ACTS badging program for clinical research coordinators. Crafted by the Rutgers Biomedical Health Sciences (RBHS), this 6-week online and asynchronous academic badge was developed in collaboration with the School of Health Professions and the New Jersey Alliance for Clinical and Translational Sciences (NJ ACTS). This badge is especially designed for Clinical Research Professionals, novice Investigators, and students with little to no clinical research or pharmaceutical experience who would like to participate in clinical research at an Academic Medical Center (AMC) functioning as a “study coordinator”. Participants will be assessed on competencies related to five domains outlined by the Joint Task Force for Clinical Trial Competency.
The course is self-paced, takes about 20 hours to complete and is structured to fit into the busy schedules of working professionals while maintaining the highest degree of academic rigor.
Free to students, faculty and staff at Rutgers, Princeton, and NJIT, minus a non-refundable $5.00 administrative fee.
A 6-Week Program Covering the Following Training Areas:
- Scientific Concepts and Research Design
- Ethical & Participant Safety Considerations
- Investigational Products Development & Regulation
- Clinical Study Operations and Site Management
- Data Management &Informatics
There is no cost for Rutgers, Princeton, NJIT or RWJBH faculty, staff or students.
|
|
NEW! Instructions for scanning signed consent forms into the RWJBH Epic System are available on the CTO website. Note that this is a new, very important requirement from our RWJBH hospital partners in order to comply with JCAHO standards. It will also assure that a copy of the consent form is easily accessible to any member of the patient’s care team who needs to see it.
|
|
Should you encounter any problems following the instructions, please create an EPIC service now ticket (as directed at the end of the document.) If you have any questions about this new directive from RWJBH, please e-mail clinicaltrials@rbhs.rutgers.edu
|
|
From the UH Office for Clinical Research: Arleen would like to remind clinical research teams to please be sure to complete a subject registration form for each day that a study participant is seen for research procedures. |
|
If, for example, your participant has a visit scheduled for one day, but must come in for an MRI or other procedure on a separate day, it is necessary to complete the registration form separately for both days.
|
|
How do I keep track of all my research participants across multiple studies in OnCore? |
|
My Console Overview
My Console is designed specifically to assist a study coordinator in managing subject visits across all of their protocols. It provides a means to view and verify visits without having to access each subject individually from the CRA Console and Subject Console.
My Console is accessed through the My Console menu item.
The initial My Console page will take you directly to the Protocol menu vertical tab where all protocols to which you are currently assigned will be viewable. Additional tab choices are Subjects, Subject Visits, and My Calendar.
My Calendar
The My Console > My Calendar vertical tab displays a monthly, weekly or daily calendar with the visits of your currently assigned subjects and/or all subjects in your currently assigned protocols. You will also see the subject sequence number in parenthesis after subject name/subject initials depending on your permissions. If there is no sequence number assigned to the protocol subject, the parenthesis will not be seen.
Visit links do not appear when any of the following conditions are present:
- The visit is anchored to On Treatment Date or On Arm Date and the system-generated planned visit date falls after any of the following: Off Arm Date, Off Treatment Date, Follow-Up Start Date, or Off Study Date.
- The visit is anchored to Consent Signed Date or On Study Date, and the system-generated planned visit date is after the Off Study Date.
- The visit is anchored to Off Treatment Date, and the system-generated planned visit date is after the Follow-Up Start Date or Off Study Date.
|
|
By default, the monthly view will display both your currently assigned subjects and subjects from your currently assigned protocols.
You can change your Calendar view options by clicking the appropriate icon under the My Calendar title. The leftmost Icon will display a daily view, the second icon displays a weekly view, the third icon displays a monthly view, and the rightmost icon returns the display to the current month/week/day, depending on your current view.
|
|
Selecting the Include Subjects From Assigned Protocols checkbox will display Subjects from Protocols where you are currently assigned as a Protocol Staff. Selecting the Include Assigned Subjects checkbox will display subjects that you are currently assigned to as Subject Staff. |
|
At the bottom of the page, clicking Print exports the My Calendar data to a PDF format. |
|
Clinical Research Pets of the Month |
December’s Clinical Research Pets of the month are two French Bulldogs by the names of Kleo and Nova. Their pet mom is Taylor Campbell, clinical research coordinator with the NJMS Infectious Disease Research Program (aka Research with a Heart.) |
|
Kleo, the Brindle Frenchie, enjoys car rides, zoom calls, resting by the fireplace, and he hates walks.
Nova, the tan Frenchie, enjoys annoying her big brother, being the center of attention, and being held like a baby.
Congratulations, Kleo, Nova and Taylor!
|
|
|
|
|
|
|
