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

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

FORMS E CHANGES Due Dates on or After January 25, 2018 grants.nih.gov/grants/guide/notice-files/NOT-OD-17-119.html Due Dates on or After January 25, 2018 FORMS E Packages Available in October 2017

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

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

FORMS E Highlights Impact on FOAs FOAs are going to change grants.nih.gov/grants/guide/notice-files/NOT-OD-17-114.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

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

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

FORMS E Highlights Clinical Trial-specific Update grants.nih.gov/grants/guide/notice-files/NOT-OD-17-118.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

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

FORMS E Highlights Appendix Material Update grants.nih.gov/grants/guide/notice-files/NOT-OD-17-098.html Appendix Material Update Revised Acceptable Materials FOA May Contain Additional Requirements Non-compliant Applications WILL be Rejected

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