Notice Number: NOT-TR-18-030
Key Dates
Release Date: July 23, 2018
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