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September 2022 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.
eIRB Announcement
If you log into eIRB this week, you’ll notice a change in the eIRB application to section 6.30.

Specifically, the eIRB application

(1) will direct you to put your study into OnCore if it meets those criteria (i.e. Clinical Trial or other study with billable clinical procedures) AND

(2) if your study meets the criteria for review by the new RBHS Scientific Review Board for Non-Oncology (i.e. meaning that the PI is an RBHS faculty person, and it is an investigator-initiated study which entails consent.)

If you have questions about the new SRB, please e-mail njacts.srbregulatory@rbhs.rutgers.edu.

If you have any questions about OnCore, please e-mail the CTO at clinicaltrials@rbhs.rutgers.edu or visit our website.
Deep6 Screener Role Now Available
With the newest release of Deep6 (and provided the cost of the identifiable query has been built into the study budget), we can now create a role for study teams to directly access the database to see charts of potential subjects. This can be done once the CTO has built the query. We think this offers a real advantage to study teams because it will allow you to easily compare the inclusion and exclusion criteria to the evidence in Epic using a user friendly menu.

Once you have completed your review of the charts, you will have a list of patients you have determined appear eligible along with the name of their primary physician, allowing you to easily make contact to obtain referrals.

Please email Justin Blucher j.blucher@rutgers.edu for more information.
Upcoming Events
RWJMS Clinical
Research Workgroup
Monday, September 19th, 2022
12:00 PM
Our monthly meeting for the RWJMS clinical research staff will be discussing EPIC, OnCore, Deep6, ClinCard, and more!
Top Trends in Clinical Trials
Thursday, September 22nd, 2022
11:00 AM
This summer Greenphire conducted its annual Market Research Survey. Sponsors, CROs and sites weighed in on the future of clinical research. 
Join us for an engaging roundtable discussion on these trends with Greenphire experts:
  • Study volume: Back to pre-pandemic levels?
  • The promising role of eClinical technology 
  • What sites want right now from sponsors & CROs
  • Why integration is a key driver of research success
Register now to discover what sparks optimism - and what may be a cause for concern - amongst your peers. 
ClinicalTrials.gov PRS Administration FREE Training 
The Clinical Trials Registration and Results Reporting Taskforce Education Subcommittee will be presenting a two-part presentation titledPRS Administration 101in late September. The presentation is intended to be an introduction to PRS administration for those who are new to their role, but is also a good refresher for PRS veterans and those who anticipate training additional staff who will be assuming PRS-related responsibilities. Each day will have approximately 90 minutes of presentations and 30 minutes for Questions and Answers.
 
Day 1

Thursday, Sept. 29, 2022, 1:00 PM - 3:00 PM EDT

"PRS Administration 101: Legal, Regulatory and Institutional Context for ClinicalTrials.gov Administrators - Why are We Doing This Work, When, and With Whom?"
Day 2

Friday, Sept. 30, 2022, 1:00 PM - 3:00 PM EDT

"PRS Administration 101: Using the ClinicalTrials.gov PRS System - Administrator Superpowers and How to Use Them for Management and Monitoring"
Collaboration and Inclusion of Patients in Clinical Trials – Understanding What’s Critical for All Stakeholders
Wednesday, October 26th, 2022
10:00 AM - 2:00 PM
Join us online to hear from patients, their families and advocates, scientists, physicians, and clinical trial specialists from hospitals and drug companies about the importance of a patient-centric clinical trial, better understanding the patient experience, and how we as an industry can improve.
Regulatory Tip of the Month
Does my study need an IND?
Many resources are available to clinical researchers at RBHS through our Clinical and Translational Science Award (CTSA), such as the Trial Innovation Network (TIN). The TIN is comprised of members from other CTSA institutions, and seeks to develop innovative solutions to the roadblocks we all face in conducting clinical research. You are encouraged to visit the TIN website and create an account to see what they have to offer.
 
This is a short how-to guide for making Investigational New Drug (IND) - Exempt Determinations. This guide will:

  • Introduce IND exemption fundamentals
  • Help users identify the single key exemption criterion
  • Discuss approaches for evaluating the criterion.

Click on the image below for the full guide.
RWJMS Corner
Guidance on scanning signed consent forms into Epic coming soon.
NJMS Corner
Additional interfaces between EPIC and OnCore are on the horizon for NJMS. Stay tuned for more information!
OnCore Quick Tip:
What is the status of my study?

Let's take a deep dive into the status function in OnCore
New: Assigned when the protocol is created.

SRB Approval: Assigned when the CTO has approved of the ePRMS submission or for IITs, when the RBHS SRB committee has completed their review of a new IIT.

IRB Initial Approval: Assigned when an IRB Initial Review is completed for the protocol.
If you need to undo this status change, you can do so as long as the IRB review record is removed and the protocol status hasn't advanced beyond the IRB Initial Approval status.

CTO Signoff: Assigned when the CTO has completed their congruency check and all documents/approvals are complete.

Open to Accrual: Assigned when the Open button is selected and the date you received approval to begin enrollment is added. An Open button is displayed after IRB initial approval and CTO signoff has been completed. When a protocol has a status of Open to Accrual, an Undo Open button appears. This button is available until a subject is registered to the protocol.

On Hold: This status is typically assigned when a sponsor puts the protocol on hold prior to opening to accrual.

  • The On Hold button is displayed until the protocol status becomes Open to Accrual.
  • The Off Hold button is displayed when a protocol is On Hold.
  • When a protocol is removed from On Hold status by clicking Off Hold, the protocol reverts to its previous status.
  • When an approved Initial IRB Review or an approved Initial SRB Review is entered for a protocol having the status On Hold, OnCore updates the status of the protocol to IRB Initial Approval or SRB Approval and inserts an Off Hold status into the table.

An Undo On Hold button appears for protocols in On Hold status, and an Undo Off Hold button appears for protocols with an Off Hold status. Clicking either button reverses the protocol status to its previous state. Note that to access these buttons, you must have the Protocol > On Hold and Protocol > Off Hold permissions.

Abandoned: This status indicates no further action is expected for this protocol. An Abandon button is displayed until a protocol is Open to Accrual. When a protocol has the status of Abandoned, an Undo Abandon button is displayed. Clicking the button reverts the protocol to its most recent valid status.

Suspended: This status indicates that a protocol is temporarily closed to accrual. OnCore does not allow you to place subjects On Study when a protocol is Suspended. A Suspend button is displayed after the protocol is marked Open to Accrual. When a protocol has a status of Suspended, an Undo Suspend button is displayed. Clicking the button reverts the protocol to its previous status.

Closed to Accrual: Indicates that a protocol is closed to accrual. The Close To Accrual button is displayed when the protocol has a status of Open to Accrual. After a protocol is marked as Closed to Accrual, an Undo Closed to Accrual button is displayed.

IRB Study Closure: Typically the final status for the protocol when the expected outcome is successfully completed. The IRB Study Closure button is displayed after the protocol is marked Closed to Accrual. When a protocol is assigned the status of IRB Study Closure, an Undo IRB Study Closure button is displayed.

Protocol-related events that are tracked as payable and have an active IRB Study Closure trigger will create payables when the associated protocol is moved to a status of IRB Study Closure on the PC Console > Status tab.

Terminated: This status is typically used when a protocol ends prior to completing the expected outcome, and indicates that no further protocol action is required. The Terminate button is displayed after the protocol is Closed to Accrual or after IRB Study Closure. When a protocol is marked as Terminated, an Undo Terminate button is available.
Clinical Research Pet of the Month
September’s RBHS Clinical Research Pet of the Month is Ash. His cat mom is Marisol Rivera, a clinical research coordinator from the NJMS CRU.
If you want your favorite pet featured in the next newsletter, reach out to us via clinicaltrials@rbhs.rutgers.edu
In addition to his natural good looks and smoky gray coat that certainly is the envy of the other cats in his neighborhood, Ash is super friendly, affectionate and has a sweet and gentle demeanor with his fellow members of the animal kingdom. His inquisitive nature keeps him hyper-focused on Marisol and her family. Since Ash doesn’t like to miss anything that is going on in his home, he can generally be found front and center, wherever his family is. 
 
Congratulations, Marisol and Ash!