From:                                         Teller, Alan [at2059@mail.cumc.columbia.edu]

Sent:                                           Friday, May 20, 2011 9:03 AM

To:                                               cuhs-irb@CUMC.COLUMBIA.EDU

Subject:                                     New Requirement for Submission of FDA-regulated Research for IRB Review

 

New Requirement for Submission of FDA-regulated Research for IRB Review

The Columbia IRB will require submission of FDA Form 1572 for all FDA-regulated studies that involve an IND.  The Principal Investigator should ensure consistency of all listed co-investigators/sub-investigators between the FDA Form 1572 and the “Personnel” section in RASCAL.

Similarly, the Columbia IRB will require submission of a Clinical Investigator Agreement as required by 21 CFR 812 for all studies that involve an IDE.

For any study for which a Columbia Faculty member will hold an IND or IDE the relevant application to FDA (FDA Form 1571 or the “Application for Investigational Device Exemption” for IDEs) should be included as an attachment in RASCAL in the submission for IRB review.