POLICiEs
This is the process for Research labs/Billing Registration
Complete Billing form
email Billing Registration
Policy 800.50 https://www.northwell.edu/sites/northwell.edu/files/2023-11/800.50-billing-compliance-policy.pdf
Internal SIUH Process
Contact ~Maria Torres
These disclosure agreements are legal documents necessary to implement funded projects and data transfers, etc
Confidential Disclosure Agreement (CDA), sometimes called a Non-Disclosure Agreement (NDA)
contact CTstudies @northwell.edu
Master Agreement – if with industry CTstudies @northwel.edu, if data transfer for data collection only studies legal depatment
Clinical Trial Agreement for Industry: CTstudies@northwell.edu
Clinical Trial Agreement for Federal-Funded GMO @northwell.edu
This group is responsible for the creation of Medicare coverage analysis for both Industry and Federally Sponsored projects.
Clinical Trials Office
CTstudies @northwell.edu
You just received a new investigational device for an IDE study. Before it can be used you must contact this department to have it evaluated and inventoried.
Clinical Engineering
You have a new study Surgery study that involved obtaining an EKG and a CT scan. You contact
Chairs of participating Departments
This is the mandate for all clinical trials in order to be accessible to all patients and investigators.
What are clinical Trials.gov
To register your study contact Office of Clinical Research OCR@northwell.edu
This process is used to set up patients reimbursement for participation
CTO to set up SMART and clin cards
Name the process for documenting and reporting deviations
PI, Local IRB, Central IRB,if applicable
You are working with a start up company that is requesting for the study team to create their own EDC as they do not have one for the study. Who can you contact to find out the price and the process?
Redcap Team
You have an investigator writing a new research protocol which involves utilizing an FDA approved drug in a population that it was not approved for.
ORC – Regulatory Affairs
This office is responsible for oversight and approval of all research proposals.
What is the IRB and the office of Human Research Protection Program
GR 056
This office is responsible for clinicaltrial.gov, FDA reporting, review of IND, eCOI
Office of Research Compliance
https://northwell.sharepoint.com/sites/Feinstein-ORC
Melissa Scotti
Hamangi Patel
You are consenting a patient who does not speak English
Contact Interpreter Line use Buddy Pass
This group evaluates the electronic data systems to be used in clinical research studies to store and analyze data.
IT Security
this is the process for presenting at a conference
what is Travel policy
You are unclear on policy re: consenting vulnerable population, you contact
1.Human Research Protection Program (HRPP) 516-465-1910 irb@northwell.edu
Office of Research Compliance 516-266-5024 orc@northwell.edu
The process for staff working on a federally funded project to verify engagement in the study
Effort Certification System (ECS) Training Guides and Forms
You are unsure of whether the investigator proposed project is research
submit HRPP form via IRB manager
You have a new study that involves collection and processing of research tissue specimens that will be sent out to the study sponsor for biobanking . Who do you contact before proceeding with IRB submission ?
Local Pathology Team
This is the process for Research labs/Billing Registration
Complete Billing form
email Billing Registration
Policy 800.50
https://www.northwell.edu/sites/northwell.edu/files/2023-11/800.50-billing-compliance-policy.pdf
This group is responsible of IA approvals
Office of Clinical Research contact IA@northwell.edu
You have a study drug that the investigator want to use off label, you submit
Expanded Use Application
You have a new drug trial that involves storage and maintenance of accountability and temperature monitoring. Who do you contact before proceeding with IRB submission
Local Pharmacy