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