Modification of RFA-RM-10-020: Institutional Clinical and Translational Science Award (CTSA) (U54)


Notice Number:  NOT-RM-11-016

Key Dates

Release Date: May 6, 2011

Issued by

National Center for Research Resources (NCRR)

Purpose

This Notice modifies the language of RFA-RM-10-020 with regard to the section on Special Program Requirements part 20 (Required Institutional Letters) and the section on Format of the Application part I (Human Subjects) to address reporting of serious and unexpected adverse events.

In RFA-RM-10-020, part 20 (Required Institutional Letters) of the section on Special Program Requirements currently reads:

20. Required Institutional Letters

Applicants must provide letters from the appropriate high-ranking institutional official(s) from the parent institution(s) and its affiliates that:

This is hereby replaced with:

20. Required Institutional Letters

Applicants must provide letters from the appropriate high-ranking institutional official(s) from the parent institution(s) and its affiliates that:

In RFA-RM-10-020, part I (Human Subjects) of the section on Format of the Application currently

does not have content:

I. Human Subjects

This is hereby replaced with:

I. Human Subjects

Where appropriate, discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects in studies supported by the CTSA. If studies that involve clinical trials (biomedical and behavioral intervention studies) are to be supported by the CTSA, include a general description of the plan for data and safety monitoring of such studies and adverse event reporting to the IRB, NCRR, NIH, and others, as appropriate, to ensure the safety of subjects.

Inquiries

Please direct all inquiries to:

Dr. Anthony Hayward
Division for Clinical Research Resources
National Center for Research Resources
Democracy One, Room 906
6701 Democracy Blvd.
Bethesda, MD 20892-4874
Telephone: (301) 435-0790
FAX: (301) 480-3661
Email: haywarda@mail.nih.gov


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