Columbia University IRB

News & Announcements

Current list of CUMC IT certified systems:

https://rsam.cumc.columbia.edu/RSAM_DEFAULT.aspx

5/12/2017

Guidance on Electronic Informed Consent (e-Consent) released

Visit the Morningside IRB Office on Tuesdays

from 10:00-11:00 am without an appointment*

When: Any Tuesday

Where: Studebaker Building

615 West 131st Street, 3rd Floor

(Building entrance is on W. 132nd Street due to construction)

Time: 10:00 – 11:00 am

*Alternatively an appointment may be scheduled

More...

Policy & Guidance Refresher

Sponsor-Investigator Responsibilities

When a Principal Investigator (PI) is acting as a Sponsor-Investigator, additional consideration must be given as to how compliance with FDA requirements will be maintained. The Columbia University FDA Compliance Program for FDA-regulated Human Subjects Research outlines the institutional oversight of S-I research.

PGR Archive

Information for Research Subjects

Research at Columbia University
What is the IRB?
Should I Participate in Research?

About the HRPP / IRB

Purpose / Scope / Responsibilities
IRB Roster and Meeting Schedule
Quality Improvement Program
Compliance Oversight
Federalwide Assurance

Contact Us

Submitting a Protocol

What Should Be Submitted to the IRB
Types of IRB Review
Protocol Templates
Consent Form Templates
Creating a New Protocol & Beyond:
- How to Apply for IRB Approval

RASCAL Tutorial
Tips for Efficient Protocol Review
Resubmitting
Creating Consent Forms

Maintaining IRB Approval

Modifying a Protocol
Renewing a Protocol
Other Reporting Requirements

-Adverse Events

     -Protocol Deviations & Violations
     -Interim Analysis / Safety Reports
     -Suspension

Closing out a Project