Notice of Modification to RFA-TR-18-020 “Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional)”

Notice Number: NOT-TR-18-030

Key Dates
Release Date: July 23, 2018

Related Announcements
RFA-TR-18-020

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

The purpose of this Notice is to modify language regarding the use of SMART IRB in RFA-TR-18-020 “Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional)”.

Section IV. Application and Submission Information
2. Content and Form of Application Submission

PHS Human Subjects and Clinical Trials Information (Administrative Core)

Currently Reads:

Single IRB for Multisite Projects

All instructions in the SF424 (R&R) Application Guide must be followed.

Revised to Read:

Single IRB for Multisite Projects

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Investigators are strongly encouraged to use SMARTIRB and its reliance agreements. https://smartirb.org/.

PHS Human Subjects and Clinical Trials Information (Clinical Research Project)

Currently Reads:

Single IRB for Multisite Projects

All instructions in the SF424 (R&R) Application Guide must be followed.

Revised to Read:

Single IRB for Multisite Projects

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Investigators are strongly encouraged to use SMARTIRB and its reliance agreements. https://smartirb.org/.

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

R. Tiina K. Urv, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-2746
Email: urvtiin@mail.nih.gov