1. Office of Sponsored Projects
NIH Updates
Roundtable
September 28, 2017
Dartmouth Campus

2. NIH Updates FORMS E Changes
New PHS Human Subjects & Clinical Trials Information Form
SF424 Guide Updates
Impact on FOAs
Clinical Trial-specific Update
Appendix Materials Update

3. FORMS E CHANGES Due Dates on or After January 25, 2018
grants.nih.gov/grants/guide/notice-files/NOT-OD html
Due Dates on or After January 25, 2018
FORMS E Packages Available in October 2017

4. FORMS E Highlights
New PHS Human Subjects & Clinical Trials Information Form
Consolidates HS Information
Expands Clinical Trial Data Collection

5. FORMS E Highlights Updated SF424 Guide Available Now
OSP will Schedule a Training Session after Nov 5th Deadline

6. FORMS E Highlights Impact on FOAs FOAs are going to change
grants.nih.gov/grants/guide/notice-files/NOT-OD html
Impact on FOAs
FOAs are going to change
Parent Announcements will be Reissued
Clinical Trial FOAs will be Reissued
Transition Period of Multiple FOAs

7. FORMS E Highlights
All New FOAs will Specify Clinical Trials Allowability in the FOA Title

8. FORMS E Highlights During the FOA Transition Period Read FOA Carefully
FOA Title
Section II of FOA
Ask Your OSP Grants Officer if you Have Questions

9. FORMS E Highlights Clinical Trial-specific Update
grants.nih.gov/grants/guide/notice-files/NOT-OD html
Clinical Trial-specific Update
New review criteria
Refer to Notice for Details
Clinical Trial Definition Resources
Web-based Decision Tool
Case Study Examples
FAQ

10. Clinical Trial Definition Tools
grants.nih.gov/ct-decision/index.htm

11. FORMS E Highlights Appendix Material Update
grants.nih.gov/grants/guide/notice-files/NOT-OD html
Appendix Material Update
Revised Acceptable Materials
FOA May Contain Additional Requirements
Non-compliant Applications WILL be Rejected

12. ~The End~
Thank you for your time. We will post the presentation slides on the OSP web site