Resources
This is the OCR CTMS OnCore contact email
What is CTMS.support@northwell.edu
This protocol-specific grid or checklist mirrors the study calendar to outline which clinical procedures are paid for by the sponsor versus insurance.
What is a billing grid (or Coverage Analysis)
This type of study is currently hard to track/ not tracked by OnCore
what is an unfunded restrospective chart review
The federal concern when insurance is billed for sponsor-paid procedures.
What is double billing?
Describe how to navigate to OCR OnCore guides and resources.
OCR SharePoint > Tools > OnCore CTMS
This is the default billing designation OnCore assigns to any new procedure added to a protocol calendar before it undergoes formal review.
What is a "Research" (R) designation?
this study was reviewed by Brany, this system must be used for invoicing
what is BRANY CTMS/study tracker
* moving away from utilize Northwell CTO so invoicing can be done directly in OnCore.
This must be completed before participant visits can be accurately billed
What is calendar activation?
The following are contacts for study billing/invoice discrepancies?
CTO Financial Operations Specialist
OCR Clinical Research Specialist (Amber Arrington, Frank Bassani)
To prove a study is legally permitted to bill routine clinical costs to third-party insurers, it must meet these criteria embedded directly inside OnCore’s CA console.
What are "Qualifying Clinical Trial" (QCT) requirements?
This specific protocol status means the study has received all institutional approvals and is actively looking for or enrolling participants.
Open to Accrual
This document often contains sponsor payment requirements.
What is the Clinical Trial Agreement (CTA)?
OnCore@northwell.edu is the contact for the following entities:
- Product Services & Management, Quantitative Intelligence (Matthew Di Micelli)
- Account Activation
- Account-related Issues
These are the three core billing designation abbreviations used on an OnCore grid to mark who is financially responsible for a procedure.
What are S (Standard of Care), R (Research), and Q (Qualifying)?
This is the first mandatory status a participant must be placed in within OnCore when they sign the informed consent form.
What is Consented
Failure to document protocol deviations may affect this.
What is billing accuracy and compliance?
The following information is needed for the OnCore Study Builds
General Information (IRB#, Study Title, Short Title, PI, Coordinators, Site)
- Most recent protocol
- All IRB approved ICFs
- Billing grid/final budget
- Peoplesoft fund #
- Date of initial submission to external IRB (if applicable) & the approval letter
- Date of all continuing review submissions to external IRB (if applicable) & the approval letter
Area where you can look up payment related information
What are CRA console-Financial Events/Protocol Events
This OnCore matrix maps out every scheduled visit, procedure, and lab test required by the protocol.
What is the Study Calendar (or Coverage Analysis)
Participants must be assigned this before visits can be linked to billing grids.
What is protocol enrollment?