Tools and Guidance for Clinical Research

Below are tools and guidance to help you conduct and manage aspects of your clinical research study. Check back often as these documents will be regularly updated.

IRB Submission Instructions – Click for instructions for submissions and reporting to the IRB
Relying on an External IRB – Click for guidance on relying on an External IRB
Northwell IRB as Single IRB – Click here for guidance on using Northwell IRB as the single IRB for your multi-site study
Maintenance of Human Subject Research Documents (f/k/a Regulatory Binder) – Click for guidance on maintaining essential research documents, tools and templates
Guides for Investigators and the Research Team
Informed Consent Guidance 
Electronic Security
Helpful Links

Guides for Investigators and the Research Team

Revised Common Rule

Getting Started

Determining what is Research and when IRB Review is Needed


Informed Consent Guidance


Electronic Security

Conducting Research

Please contact the Office of Research Compliance at if you’d like to inquire about our fee for service monitoring that we provide to health system sponsor-investigators.