NIH have issued FORMS E for applications due after January 25th 2018. One major change that we want to highlight is the importance of identifying at the outset if your study is a clinical trial, as this now impacts which funding opportunity you select.
Please see https://grants.nih.gov/grants/guide/parent_announcements.htm for the list of NIH parent announcements for the new FORMS-E packages. Note that Parent announcements are now split by Clinical Trial Required, and Clinical Trial Not Allowed. For example, the R01 parent solicitation has changed from 16-160 to 18-484 (clinical trial not allowed) and 18-345 (clinical trial required).
If you need help in determining if your proposal is a clinical trial, please see https://grants.nih.gov/ct-decision/index.htm which brings you through 4 questions to help you decide. We found the case studies https://grants.nih.gov/policy/clinical-trials/case-studies.htm particularly useful.
Note that Cayuse have implemented these changes so there are new screens to reflect this. Give yourself plenty of time during proposal preparation to familiarize yourself with what is now required in these sections.
