NIH Applications submitted after January 25, 2018 must now use the new FORMS-E application package.
The most significant change with the new FORMS-E Application Package is the addition of a new PHS Human Subjects and Clinical Trials Information form. This form consolidates human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms. The form collects information on human subjects and clinical trials at the study level.
The updated NIH Application instructions contains significant changes beginning on page 10.
Additional NIH resources to gain a better understanding of the changes check out the Annotated Form Sets including this 9 minute walk through video on the new Human Subjects and Clinical Trial form.